Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Crohn Disease
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03440372
- Testing
- Ozanimod
- Where
- 408 sites in United States, Argentina and 33 more
- Volunteers
- 625 people
- Sponsor
- Celgene
Ulcerative Colitis
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
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 evaluate how safe and effective risankizumab is…
- Trial name
- REVAMP (NCT06880744)
- Testing
- Risankizumab, Vedolizumab
- Where
- 270 sites in United States, Austria and 29 more
- Volunteers
- 573 people
- Sponsor
- AbbVie
Ulcerative Colitis
Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658
- Trial name
- FUSCIA (NCT01659138)
- Testing
- SAR339658
- Where
- 41 sites in United States, Austria and 5 more
- Volunteers
- 28 people
- Sponsor
- Sanofi
Crohn's Disease
A Study of SL-325 in Crohn's Disease Patients
The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.
- Trial name
- RECEPTIVE-CD1 (NCT07753850)
- Testing
- SL-325
- Where
- 20 sites in United States
- Volunteers
- 232 people
- Sponsor
- Shattuck Labs, Inc.
Colitis Ulcerative
Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC.
- Trial name
- RESOLUTE (NCT05588843)
- Testing
- SAR443122
- Where
- 106 sites in United States, Argentina and 17 more
- Volunteers
- 187 people
- Sponsor
- Sanofi
Inflammatory Bowel Disease
Bone Marrow Stromal Cells for Inflammatory Bowel Diseases
Background: Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types, including bone, cartilage, marrow, and blood cells.
- Trial name
- NCT01851343
- Testing
- Bone Marrow Stromal Cell (BMSC) Infusion
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ulcerative Colitis
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
- Trial name
- SMART (NCT02155335)
- Testing
- Prefilled Syringe delivery of Golimumab, Smartject Device delivery of Golimumab
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease.
- Trial name
- NCT03677648
- Testing
- SHR0302
- Where
- 82 sites in United States, China and 2 more
- Volunteers
- 112 people
- Sponsor
- Reistone Biopharma Company Limited
Colitis, Ulcerative
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years…
- Trial name
- ELEVATE-UCkids (NCT07470879)
- Testing
- Etrasimod
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Ulcerative Colitis
Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies…
- Trial name
- NCT05177835
- Testing
- ABX464
- Where
- 46 sites in Austria, Belgium and 12 more
- Volunteers
- 203 people
- Sponsor
- Abivax S.A.
Crohn's Disease
Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease
The human immune system is usually tolerant of the millions of beneficial commensal bacteria (the microbiome), which colonize the healthy intestinal tract.
- Trial name
- NCT01847170
- Testing
- Fecal Microbial Transplantation
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
- NCT00295165
- Testing
- Sargramostim (Leukine)
- Where
- 111 sites in United States, Australia and 9 more
- Volunteers
- 33 people
- Sponsor
- Genzyme, a Sanofi Company
Ulcerative Colitis
Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
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).
- Trial name
- NCT06764706
- Where
- 57 sites in Germany
- Volunteers
- 200 people
- Sponsor
- AbbVie
Moderately to Severely Active Crohn's Disease, Crohn Disease
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
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.
- Conditions
- Moderately to Severely Active Crohn's Disease, Crohn Disease, Disease Crohn
- Trial name
- VECTORS (NCT06257706)
- Testing
- Vedolizumab
- Where
- 69 sites in United States, Australia and 11 more
- Volunteers
- 304 people
- Sponsor
- Alimentiv Inc.
Ulcerative Colitis
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.
- Trial name
- NCT06073873
- Testing
- Ozanimod
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Bristol-Myers Squibb
Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
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…
- Trial name
- STARSCAPE-1 (NCT07184931)
- Testing
- Duvakitug
- Where
- 461 sites in United States, Argentina and 34 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Colitis, Ulcerative
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
- Trial name
- NCT00488631
- Testing
- Golimumab 50 mg, Golimumab 100 mg, Golimumab 200 mg
- Where
- 297 sites in United States, Australia and 24 more
- Volunteers
- 1,228 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.
- Trial name
- CD02 (NCT00038766)
- Testing
- semapimod
- Where
- 13 sites in United States
- Volunteers
- 33 people
- Sponsor
- Ferring Pharmaceuticals
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative…
- Trial name
- NCT04504383
- Testing
- PN-943
- Where
- 122 sites in United States, Austria and 11 more
- Volunteers
- 169 people
- Sponsor
- Protagonist Therapeutics, Inc.
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC