Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Crohn Disease, Colitis, Ulcerative
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).
- Trial name
- NCT05668013
- Testing
- TEV-48574 Dose Regimen A, TEV-48574 Dose Regiment B
- Where
- 93 sites in United States, Austria and 14 more
- Volunteers
- 247 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Ulcerative Colitis
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC.
- Trial name
- NCT05743010
- Testing
- APL-1401
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Crohn's Disease
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
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…
- Trial name
- VICTRIVA (NCT06227910)
- Testing
- Vedolizumab, Upadacitinib
- Where
- 138 sites in United States, Austria and 24 more
- Volunteers
- 396 people
- Sponsor
- Takeda
Moderate to Severe Ulcerative Colitis
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo
The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life [QoL]), workability, and disease activity.
- Trial name
- AdaProQuo (NCT02092389)
- Volunteers
- 10 people
- Sponsor
- AbbVie
Crohn Disease
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
- Trial name
- NCT00206674
- Testing
- Sargramostim (Leukine)
- Where
- 70 sites in Argentina, Australia and 7 more
- Volunteers
- 286 people
- Sponsor
- Genzyme, a Sanofi Company
Crohn's Disease
A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately Severe Crohn's Disease
- Trial name
- NCT00446433
- Testing
- CC-5013
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 90 people
- Sponsor
- Celgene Corporation
Ulcerative Colitis (UC)
A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)
This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC).
- Trial name
- NCT07062185
- Testing
- ENC1018 capsule administration group
- Volunteers
- 10 people
- Sponsor
- Tang-Du Hospital
Crohn's Disease
Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease
The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.
- Trial name
- NCT02148185
- Testing
- MT-1303
- Where
- 2 sites in Japan
- Volunteers
- 1 people
- Sponsor
- Tanabe Pharma Corporation
Crohn Disease
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
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…
- Trial name
- DUET ENCORE-CD (NCT07577843)
- Testing
- JNJ-78934804, Guselkumab
- Where
- 287 sites in United States, Argentina and 28 more
- Volunteers
- 460 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
- Trial name
- NCT03345836
- Testing
- Upadacitinib
- Where
- 428 sites in United States, Argentina and 46 more
- Volunteers
- 624 people
- Sponsor
- AbbVie
Crohn's Disease
A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease
This is a phase 2, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants…
- Trial name
- CHROMA CD (NCT06958536)
- Testing
- brivekimig
- Where
- 78 sites in United States, Australia and 10 more
- Volunteers
- 99 people
- Sponsor
- Sanofi
Ulcerative Colitis
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02895100
- Testing
- PTG-100
- Where
- 98 sites in United States, Australia and 15 more
- Volunteers
- 98 people
- Sponsor
- Protagonist Therapeutics, Inc.
Crohn's Disease
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT00055367
- Testing
- natalizumab
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Biogen
Ulcerative Colitis
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
- Trial name
- NCT02958865
- Testing
- PF-06700841, PF-06651600
- Where
- 189 sites in United States, Austria and 17 more
- Volunteers
- 319 people
- Sponsor
- Pfizer
Ulcerative Colitis
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
- Trial name
- NCT00787202
- Testing
- CP- 690 550
- Where
- 59 sites in Belgium, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Pfizer
Crohn's Disease
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT03105128
- Testing
- risankizumab IV, risankizumab SC
- Where
- 475 sites in United States, Argentina and 42 more
- Volunteers
- 931 people
- Sponsor
- AbbVie
Crohn Disease
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
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…
- Trial name
- CHARGE (NCT07499232)
- Testing
- Guselkumab, Risankizumab
- Where
- 164 sites in United States, Austria and 15 more
- Volunteers
- 530 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
- Trial name
- NCT00524537
- Volunteers
- 5,025 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Inflammatory Bowel Disease
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD).
- Trial name
- MANTA (NCT03201445)
- Testing
- Filgotinib, Standard of Care
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 139 people
- Sponsor
- Lakefront Biotherapeutics NV
Crohn's Disease
Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine) versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic Scoring in Crohn's Disease) score.
- Trial name
- NCT01817972
- Testing
- Certolizumab pegol, Azathioprine
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Gastroenterology Research of America