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87 studies
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- Crohn's / ulcerative colitis (IBD)
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Testing the long-term safety of an under-the-skin injection in children with ulcerative colitis,
📍 Emory University · Atlanta, GA · +4 more US sites · Get directions →
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
- Asthma
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
Testing a skin shot medication in children with severe eosinophilic asthma
📍 Research Site · Mobile, AL · +27 more US sites · Get directions →
A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.
- Crohn's / ulcerative colitis (IBD)
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Testing guselkumab in children with Crohn's disease at week 52
📍 Cedars Sinai Medical Center · Los Angeles, CA · +13 more US sites · Get directions →
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
- Crohn's / ulcerative colitis (IBD)
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Testing a drug given during maintenance to help people with Crohn's disease stay stable
📍 Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 · Colorado Springs, CO · +21 more US sites · Get directions →
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
- Crohn's / ulcerative colitis (IBD)
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Testing a treatment during maintenance for moderately to severely active ulcerative colitis
📍 Del Sol Research Management, LLC - Site Number: 8400012 · Tucson, AZ · +25 more US sites · Get directions →
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
- Crohn's / ulcerative colitis (IBD)
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Looking at tests and scans in children newly diagnosed with Crohn’s disease
📍 Phoenix Children's Hospital · Phoenix, AZ · +21 more US sites · Get directions →
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children.
- Asthma
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Testing whether tezepelumab works and is safe for children with severe asthma
📍 Research Site · Montgomery, AL · +29 more US sites · Get directions →
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
- Type 2 diabetesHigh cholesterol
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome
Testing whether a daily cholesterol medicine, alone or with ezetimibe, works on top of standard
📍 Clinical Research Institute of Arizona · Sun City West, AZ · +19 more US sites · Get directions →
This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
- Lupus (SLE)
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
Testing whether adding two lupus medicines to standard care improves kidney results
📍 AARA Clinical Research · Glendale, AZ · +6 more US sites · Get directions →
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
- Crohn's / ulcerative colitis (IBD)
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Testing a medicine combination and then a single medicine for ulcerative colitis in adults
📍 Digestive Health Specialsits · Dothan, AL · +38 more US sites · Get directions →
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.
- Crohn's / ulcerative colitis (IBD)
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Testing how a medicine given under the skin works in children with IBD
📍 Phoenix Children's Hospital · Phoenix, AZ · +13 more US sites · Get directions →
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks.
- Lupus (SLE)
Dapagliflozin in Active Lupus Nephritis
Testing dapagliflozin for lupus-related kidney inflammation (kidney disease)
📍 Massachusetts General Hospital · Boston, MA · +1 more US site · Get directions →
Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease.
- Lupus (SLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Testing enpatoran over 24 weeks for skin lupus symptoms, with or without whole-body disease
📍 Inland Rheumatology Clinical Trials, Inc. · Upland, CA · +7 more US sites · Get directions →
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.
- Asthma
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Testing an add-on treatment given every 6 months for severe asthma not controlled by inhaled
📍 Research Site 13 · Bakersfield, CA · +12 more US sites · Get directions →
The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.
- COPD (chronic lung disease)Asthma
The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
Testing whether positive airway pressure helps a lung medicine (NAC) reach mucus plugs in asthma or
📍 UCSF Airway Clinical Research Center · San Francisco, CA · Get directions →
The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are: * Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure.
- Asthma
Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
Testing whether adding benralizumab helps adults with uncontrolled asthma
📍 Research Site · Chandler, AZ · +33 more US sites · Get directions →
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
- Asthma
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
Testing a medicine in people with asthma to study lung changes
📍 GSK Investigational Site · Brooksville, FL · +8 more US sites · Get directions →
Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.
- Asthma
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Studying what causes breathing out to get harder during asthma flare-ups
📍 Arthur F Gelb Medical Corporation · Lakewood, CA · Get directions →
The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists.
- Crohn's / ulcerative colitis (IBD)
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Testing a combination of two medicines to treat Crohn’s bowel inflammation vs one medicine
📍 UCSD Medical Center · La Jolla, CA · +18 more US sites · Get directions →
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants.
- Lupus (SLE)
Trial of Belimumab in Early Lupus
Testing belimumab in people with lupus diagnosed within 2 years
📍 Feinstein Institute · Manhasset, NY · Get directions →
This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years.
- Crohn's / ulcerative colitis (IBD)
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
Testing whether fluconazole improves responses to IL-23 therapy in Crohn’s disease
📍 Weill Cornell Medicine · New York, NY · Get directions →
The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.
- Lupus (SLE)
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Testing long-term safety of ianalumab for people with lupus
📍 Pinnacle Research Group Llc · Anniston, AL · +20 more US sites · Get directions →
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
- Crohn's / ulcerative colitis (IBD)
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Testing how a medicine given by IV or shot affects Crohn’s disease in children
📍 Phoenix Children's Hospital /ID# 255766 · Phoenix, AZ · +10 more US sites · Get directions →
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.
- Lupus (SLE)
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Testing LUPKYNIS with other lupus medicines for kidney response in lupus nephritis
📍 Purushotham & Akther Kotha MD, Inc. · La Mesa, CA · +14 more US sites · Get directions →
The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).
- Asthma
A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
Testing a medicine added to usual care to prevent asthma flare-ups in teens and adults with type 2
📍 GSK Investigational Site · Newport Beach, CA · +7 more US sites · Get directions →
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
- Crohn's / ulcerative colitis (IBD)
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Studying how risankizumab works and its safety for youth with ulcerative colitis
📍 Phoenix Children's Hospital /ID# 273015 · Phoenix, AZ · +10 more US sites · Get directions →
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC.
- Asthma
45th Multicenter Airway Research Collaboration
Testing an emergency department treatment to prevent asthma attacks from coming back
📍 MetroHealth · Cleveland, OH · Get directions →
The study is a randomized controlled trial on the effect of emergency department initiation of Airsupra on acute asthma "recurrence" at 3 months and other related outcomes (acute asthma relapse, asthma control).
- Asthma
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Testing a skin injection of dupilumab for asthma in children ages 2 to under 6
📍 Phoenix Children's Hospital- Site Number : 8400001 · Phoenix, AZ · +13 more US sites · Get directions →
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts.
- Asthma
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Testing a new way to match asthma patients to biologic treatments using genetic and lab measures
📍 Mayo Clinic · Scottsdale, AZ · +2 more US sites · Get directions →
In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.
- Lupus (SLE)
Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
Testing what happens to older people with lupus if they stop their hydroxychloroquine
📍 University of California, Los Angeles · Los Angeles, CA · +9 more US sites · Get directions →
Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use.
- Lupus (SLE)
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
Testing the safety and effects of belimumab in early lupus adults
📍 GSK Investigational Site · Anniston, AL · +39 more US sites · Get directions →
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable first-line SLE therapy.
- Crohn's / ulcerative colitis (IBD)
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Testing a medicine called duvakitug for safety and benefit in ulcerative colitis
📍 Onyx Clinical Research - Site Number: 8400021 · Peoria, AZ · +39 more US sites · Get directions →
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study.
- Crohn's / ulcerative colitis (IBD)
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Testing a medicine in children with moderate to severe ulcerative colitis
📍 Children's Healthcare of Atlanta · Atlanta, GA · +1 more US site · Get directions →
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
- Lupus (SLE)💵 May compensate
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Testing whether cenerimod added to usual treatment helps adults with active lupus nephritis
📍 Alloy Clinical Research LLC · Kissimmee, FL · +10 more US sites · Get directions →
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod.
- Crohn's / ulcerative colitis (IBD)
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Comparing two medicines for Crohn’s disease with moderate to severe activity
📍 Digestive Health Specialists of the Southeast · Dothan, AL · +24 more US sites · Get directions →
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
- Asthma
Azithromycin for Critical Asthma - Pediatrics
Testing azithromycin in children with severe asthma to change the immune response
📍 Johns Hopkins All Children's Hospital · St. Petersburg, FL · Get directions →
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
- Asthma
CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
Helping community health clinic clinicians prescribe recommended asthma care
📍 Affinia healthcare, 2220 Lemp Ave · St Louis, MO · +6 more US sites · Get directions →
Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy). The investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers.
- Obesity / overweightCrohn's / ulcerative colitis (IBD)
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Testing two medicines together to reduce ulcerative colitis symptoms and weight in adults with
📍 Digestive Health Specialists · Dothan, AL · +36 more US sites · Get directions →
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
- Obesity / overweightCrohn's / ulcerative colitis (IBD)
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Testing treatments for adults with Crohn’s disease and excess weight
📍 Digestive Health Specialists · Dothan, AL · +34 more US sites · Get directions →
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.
- Crohn's / ulcerative colitis (IBD)
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Testing whether healing through the whole bowel wall is a good treatment goal in Crohn’s disease
📍 TLC Clinical Research Inc - Los Angeles · Los Angeles, CA · +2 more US sites · Get directions →
Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes.
- Crohn's / ulcerative colitis (IBD)
Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis
Testing the best medication sequence for acute severe ulcerative colitis using a drug plus steroids
📍 University of Michigan · Ann Arbor, MI · Get directions →
This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC). This research is studying multiple drugs already approved by the Food and Drug Administration (FDA).
- Asthma
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Testing an added medicine given every 6 months for severe asthma not controlled
📍 Research Site 23 · Northridge, CA · +33 more US sites · Get directions →
The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.
- Crohn's / ulcerative colitis (IBD)💵 May compensate
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Testing whether mirikizumab is safe and works for people with Crohn’s strictures
📍 Digestive & Liver Center of Florida · Orlando, FL · +1 more US site · Get directions →
This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.
- Crohn's / ulcerative colitis (IBD)
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Testing whether tulisokibart works and is safe for people with Crohn’s disease
📍 Digestive Health Specialists ( Site 5064) · Dothan, AL · +39 more US sites · Get directions →
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
- Crohn's / ulcerative colitis (IBD)
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Testing mirikizumab in kids with Crohn’s disease for safety and how it works
📍 Cedars Sinai Medical Center · Los Angeles, CA · +14 more US sites · Get directions →
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.
- Lupus (SLE)
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Testing the safety of a shingles vaccine in people with lupus
📍 NYU Langone Health · New York, NY · +1 more US site · Get directions →
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment.
- Crohn's / ulcerative colitis (IBD)
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Comparing two laxatives for bowel prep before colonoscopy in IBD
📍 University of Manitoba · Winnipeg, Manitoba · Get directions →
The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).
- Crohn's / ulcerative colitis (IBD)
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
Testing whether treatment for ulcerative colitis or Crohn's helps symptoms go away after 14 weeks
📍 Gastro Health Research- St. Vincents East · Birmingham, AL · +39 more US sites · Get directions →
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).
- Asthma
Ventilation and Perfusion in Asthmatics
Testing how inhaled asthma medicines change breathing and blood flow in adults
📍 University of Miami - Converge Miami · Miami, FL · Get directions →
Assess regional changes to perfusion and ventilation from inhaled corticosteroid (ICS) and Fast-acting beta-antagonist (FABA) among adult asthmatics using radiographically derived estimates of regional ventilation (V-distribution), ventilation defect percentage (VDP), and ventilation heterogeneity (VH).
- Lupus (SLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Testing a treatment called enpatoran for skin lupus symptoms over 24 weeks
📍 Dermatology Research Associates - 300204025 · Los Angeles, CA · +10 more US sites · Get directions →
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.
- Asthma
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Comparing two as-needed inhalers to prevent severe asthma flare-ups in teens
📍 Research Site · Anchorage, AK · +39 more US sites · Get directions →
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
- Crohn's / ulcerative colitis (IBD)
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Testing a Crohn’s disease medicine against guselkumab for safety and effects
📍 Clinnova Research · Anaheim, CA · +5 more US sites · Get directions →
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
- Lupus (SLE)
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
Testing an IV medicine to study effects and safety in children with lupus
📍 Research Site · Phoenix, AZ · +21 more US sites · Get directions →
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Crohn's / ulcerative colitis (IBD)
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Testing how well and how safely upadacitinib works in children with Crohn’s disease
📍 UCSF Benioff Children's Hospital - Oakland /ID# 262217 · Oakland, CA · +11 more US sites · Get directions →
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss.
- Crohn's / ulcerative colitis (IBD)
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Testing long-term skin shots of vedolizumab in children with ulcerative colitis or Crohn’s and
📍 Phoenix Childrens Hospital · Phoenix, AZ · +13 more US sites · Get directions →
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.
- Crohn's / ulcerative colitis (IBD)
Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis
Testing if personalized treatment plans for severe ulcerative colitis in hospital are workable
📍 University of Michigan · Ann Arbor, MI · Get directions →
The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.
- Crohn's / ulcerative colitis (IBD)
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Testing whether reducing injections of ustekinumab can keep Crohn’s or colitis in remission
📍 MUHC - Montreal General Hospital · Montreal, Quebec · Get directions →
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST). The main question it aims to answer is: Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response?
- Crohn's / ulcerative colitis (IBD)
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Testing the safety and effectiveness of duvakitug for active Crohn’s disease
📍 Onyx Clinical Research - Site Number: 8400021 · Peoria, AZ · +39 more US sites · Get directions →
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period.
- Lupus (SLE)
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Tracking how anifrolumab passes into breast milk and affects infants in people with lupus
📍 Research Site · Las Vegas, NV · Get directions →
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.
- Crohn's / ulcerative colitis (IBD)
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Testing how well and how safely icotrokinra works for Crohn's disease
📍 AZ Gastro Care · Chandler, AZ · +39 more US sites · Get directions →
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
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