Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Colitis, Ulcerative, Crohn Disease
A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical…
- Conditions
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- Trial name
- GLAMOUR (NCT07851207)
- Volunteers
- 200 people
- Sponsor
- Janssen-Cilag Ltd.
Ulcerative Colitis
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active…
- Trial name
- NCT06570772
- Testing
- AVT16, Vedolizumab
- Where
- 100 sites in Argentina, Bulgaria and 9 more
- Volunteers
- 301 people
- Sponsor
- Alvotech Swiss AG
Exclusive Enteral Nutrition, Ulcerative Colitis
Combined Application of EEN in the Induction of Remission in PUC
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear.
- Conditions
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- Trial name
- NCT04999241
- Testing
- exclusive enteral nutrition, regular food
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Fudan University
Bacteria, Microbiota
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism.
- Conditions
- Bacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel Disease
- Trial name
- NCT01790061
- Testing
- Standardized FMT, Traditional treatments
- Where
- China
- Volunteers
- 500 people
- Sponsor
- The Second Hospital of Nanjing Medical University
Crohn's Disease
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
- Trial name
- DUET-CD (NCT05242471)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 456 sites in United States, Australia and 34 more
- Volunteers
- 703 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world.
- Trial name
- UPlift (NCT05930275)
- Where
- 180 sites in Australia, Bulgaria and 15 more
- Volunteers
- 1,200 people
- Sponsor
- AbbVie
Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
- Trial name
- NCT06430801
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 499 sites in United States, Australia and 45 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective Humira (adalimumab) is in treating moderately to severely active CD in China.
- Trial name
- NCT05394805
- Where
- 10 sites in China
- Volunteers
- 156 people
- Sponsor
- AbbVie
Crohn's Disease
Extension Study of Semapimod 60 mg IV x 3 Days
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study.
- Trial name
- CD06 (NCT00741910)
- Testing
- Semapimod
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 15 people
- Sponsor
- Ferring Pharmaceuticals
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Ulcerative Colitis
An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon.
- Trial name
- NCT05791526
- Where
- 114 sites in Japan
- Volunteers
- 308 people
- Sponsor
- AbbVie
Crohn's Disease
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
- Trial name
- NCT00584740
- Testing
- AIN457
- Where
- 2 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Crohn Disease
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.
- Trial name
- NCT01218360
- Testing
- Physician standard-of-care
- Volunteers
- 71 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related…
- Trial name
- NCT00409617
- Testing
- adalimumab
- Where
- 189 sites in Austria, Belgium and 15 more
- Volunteers
- 945 people
- Sponsor
- Abbott
Ulcerative Colitis
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of…
- Trial name
- CONCLUDE (NCT04985968)
- Testing
- Cobitolimod 250 mg, Cobitolimod 500 mg
- Where
- 203 sites in United States, Australia and 26 more
- Volunteers
- 171 people
- Sponsor
- InDex Pharmaceuticals
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT04799496
- Where
- 43 sites in South Korea
- Volunteers
- 688 people
- Sponsor
- Takeda
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.
Ulcerative Colitis
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment…
- Trial name
- ELEVATE UC OLE (NCT03950232)
- Testing
- Etrasimod
- Where
- 472 sites in United States, Argentina and 37 more
- Volunteers
- 896 people
- Sponsor
- Pfizer
Ulcerative Colitis
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
- Trial name
- Touchstone (NCT01647516)
- Testing
- Ozanimod
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 199 people
- Sponsor
- Celgene