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126 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).
- 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.
- Fatty liver disease (NASH/MASH)
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Testing an experimental medicine for MASLD or MASH in adults
📍 Arizona Liver Health · Chandler, AZ · +1 more US site · Get directions →
This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B).
- 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.
- Fatty liver disease (NASH/MASH)
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Testing a new medicine for liver disease in adults with extra body fat
📍 Altasciences Clinical Company, Inc · Montreal, Quebec · Get directions →
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine.
- Fatty liver disease (NASH/MASH)💵 May compensate
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Testing how efimosfermin alfa compares with placebo for MASH with scarred liver tissue
📍 GSK Investigational Site · Arcadia, CA · +39 more US sites · Get directions →
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
- 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.
- Type 2 diabetesFatty liver disease (NASH/MASH)
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
Testing QX1206 in people with type 2 diabetes and fatty liver
📍 Centricity Research Toronto LMC. · Toronto, · Get directions →
This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose.
- Lupus (SLE)Eczema / atopic dermatitis
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Testing whether baricitinib is safe in people with Job syndrome and lupus or eczema
📍 National Institutes of Health Clinical Center · Bethesda, MD · Get directions →
Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones.
- 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)
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
Testing a cell therapy made from a person’s own immune cells for lupus
📍 Children's Hospital of Philadelphia · Philadelphia, PA · Get directions →
This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE).
- Lupus (SLE)
US Zamto-cel Autoimmune Diseases
Testing the safety of an experimental cell therapy for lupus
📍 Froedtert Hospital and the Medical College of Wisconsin · Milwaukee, WI · Get directions →
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.
- 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.
- Lupus (SLE)
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Testing the safety and early effects of a new treatment for lupus in adults
📍 Research Site 4 · Redwood City, CA · +6 more US sites · Get directions →
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
- Crohn's / ulcerative colitis (IBD)
An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
Testing how afimkibart in people with ulcerative colitis affects drug processing in the liver
📍 Erick H. Alayo Medical Corporation - Gastro SB Clinic · Chula Vista, CA · +1 more US site · Get directions →
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
- Lupus (SLE)
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Testing the safety and tolerance of budoprutug in adults with lupus
📍 Climb Bio Investigative Site #100104 · Allen, TX · +1 more US site · Get directions →
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Crohn's / ulcerative colitis (IBD)
Autologous Stem Cell Transplantation for Crohn's Disease
Testing stem cell treatment for severe Crohn's disease in teens and adults
📍 UPMC Prebyterian- Adult Gastroenterology · Pittsburgh, PA · +1 more US site · Get directions →
The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.
- Lupus (SLE)Rheumatoid arthritis
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Testing a CD19-targeted CAR T cell treatment in people with severe lupus or rheumatoid arthritis
📍 University of Colorado Anschutz Medical Campus · Aurora, CO · +30 more US sites · Get directions →
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Fatty liver disease (NASH/MASH)
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Testing a drug to treat fat buildup liver disease in people with stage 2 or 3 fibrosis
📍 Akero Clinical Study Site · Birmingham, AL · +39 more US sites · Get directions →
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
- Crohn's / ulcerative colitis (IBD)
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Testing vorinostat in people with moderate to severe Crohn’s disease and using ustekinumab to
📍 National Institutes of Health Clinical Center · Bethesda, MD · Get directions →
Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut.
- 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)
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
Testing different doses of an experimental medicine for lupus
📍 GSK Investigational Site · Buenos Aires, · Get directions →
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose.
- Lupus (SLE)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Testing an immune treatment for safety and effects on B-cells in lupus
📍 Wallace Rheumatic Center · Beverly Hills, CA · +15 more US sites · Get directions →
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
- Lupus (SLE)
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Testing the safety and effects of CABA-201 in people with active lupus
📍 University of California Irvine · Orange, CA · +20 more US sites · Get directions →
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Fatty liver disease (NASH/MASH)
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Testing whether two doses of pegozafermin are safe and work for liver scarring in adults with MASH
📍 89bio Clinical Study Site · Birmingham, AL · +39 more US sites · Get directions →
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- 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).
- Lupus (SLE)
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Testing safety and best dose for CAR-T cell treatment in adults with lupus
📍 Nationwide Children's · Columbus, OH · Get directions →
This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.
- 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.
- Obesity / overweightFatty liver disease (NASH/MASH)💵 May compensate
Human Models of Selective Insulin Resistance: Alpelisib, Part I
Testing how insulin works in healthy people versus people at risk for type 2 diabetes
📍 Columbia University Irving Medical Center · New York, NY · Get directions →
The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin.
- Crohn's / ulcerative colitis (IBD)
Treatment of Moderate to Severe Refractory Crohn's Disease
Testing different doses of a new treatment for Crohn’s disease
📍 Mayo Clinic Arizona · Scottsdale, AZ · +12 more US sites · Get directions →
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
- 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).
- 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.
- Obesity / overweightFatty liver disease (NASH/MASH)💵 May compensate
Fibrosis Lessens After Metabolic Surgery
Testing whether metabolic surgery can reduce liver scarring in obesity
📍 Banner Health Center · Phoenix, AZ · +3 more US sites · Get directions →
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma.
- 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.
- Lupus (SLE)
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Testing a CAR T cell treatment for adults with hard-to-treat lupus
📍 Research Site · San Francisco, CA · +14 more US sites · Get directions →
This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.
- Fatty liver disease (NASH/MASH)💵 May compensate
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Testing whether pegozafermin is safe and works for MASH-related liver cirrhosis
📍 89bio Clinical Study Site · Birmingham, AL · +39 more US sites · Get directions →
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
- 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.
- Lupus (SLE)
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)
Testing side effects and how an intravenous drug works in lupus and Sjogren’s
📍 Life Clinical Trials - Colonial Drive - Margate /ID# 276050 · Margate, FL · +3 more US sites · Get directions →
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. ABBV-319 exhibits potential B cell depletion in SLE and SjD which are characterized by B cell hyperactivity.
- 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).
- Lupus (SLE)
REACT-01: Reversing Autoimmunity Through Cell Therapy
Testing a modified immune cell therapy for children and young adults with lupus
📍 Seattle Children's Hospital · Seattle, WA · Get directions →
This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR) A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.
- Lupus (SLE)
Alnuctamab for Refractory SLE (LATTE Study)
Testing alnuctamab in people with moderate to severe lupus not helped
📍 Icahn School of Medicine at Mount Sinai · New York, NY · Get directions →
This study will assess the safety and preliminary efficacy of the bi-specific TCE, alnuctamab (known as BMS-986349, CC-93269, EM901), targeting BCMA in patients with moderate to severe SLE, refractory to standard-of-care treatments.
- 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.
- Lupus (SLE)
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Testing the safety and best dose of an immune cell treatment with lupus drugs and chemotherapy
📍 MD Anderson Cancer Center · Houston, TX · +1 more US site · Get directions →
The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.
- 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).
- 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.
- Fatty liver disease (NASH/MASH)💵 May compensate
Evaluating the Pharmacokinetics and Safety of Miricorilant
Testing how a drug works in the body and its safety in adults with MASH
📍 Site# 433 · San Antonio, TX · Get directions →
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- 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.
- Fatty liver disease (NASH/MASH)
Bicalutamide Therapy in Young Women With NAFLD and PCOS
Testing bicalutamide in young women with fatty liver inflammation (NASH) and PCOS
📍 University of California San Francisco · San Francisco, CA · Get directions →
Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.
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