IBD Clinical Trials

Ulcerative Colitis Trials | Crohn's Disease Trials

Ulcerative Colitis Clinical Trials

A3921094: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral CP-690,550 as an Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis.

CP-690,550 is a potent, selective inhibitor of the JAK family of kinases with a high degree of selectivity against other kinases in the human genome. The broad effects of JAK1/3 inhibition on multiple cytokine pathways provides the rationale for developing CP-690,550 as treatment for diseases in which lymphocyte activation/proliferation plays a pathogenic role.

Patients must be at least 18 years old have moderately to severely active ucerative clitis that has failed to responde to the following treatments:

• Oral corticosteroids, Azathioprine or 6-MP, anti-TNF therapy.

AMG 181: A Randomized, Double-Blind, Multiple Dose Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis.

The goal of this study is to evaluate the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score ≤ 2, with no individual subscore > 1 point.

AMG 181 is a fully human monoclonal immunoglobulin IgG2 antibody that specifically recognizes the human α4β7 integrin heterodimer. AMG 181 binds α4β7 with high affinity and blocks its interaction with MAdCAM-1.

Patients must be between 18 to 65 years of age with moderate to severe active Ulcerative Colitis. Patients must have demonstrated either an inadequate response to, loss of response to, or intolerance to one of the following:

• Immunomodulators
• Anti-TNF agents

RPC01-202: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy with RPC1063 in Patients with Moderately to Severely Active Ulcerative Colitis.

The goal of this study is to compare the efficacy of RPC1063 vs placebo for induction of clinical remission at Week 8 in patients with moderately to severely active ulcerative colitis.

RPC1063 is a small molecule compound that selectively and potently activates S1P1R, a G protein-coupled receptor whose natural ligand is sphingosine 1-phosphate. S1P1R is expressed by many cells, including vascular endothelial cells, brain cells, and lymphocytes.

Patients must be 18 to 65 years of age with a diagnosis of active UC. Patients must be receiving at least 1 of the following therapies:

• Oral aminosalicylates
• Prednisone

Crohn's Disease Clinical Trials

OPERA: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders.

The goal of this study is to determine the efficacy of PF-00547659 compared with placebo to induce response in patients with moderately to severly active CD.

PF-00547659 is an antibody targeting MAdCAM receptors in the blood vessels of the small bowel and colon. Blocking MAdCAM prevents leukocytes (white blood cells) from moving into the small bowel and colon and is the proposed mechanism of action.

Patients must be between 18 - 75 years of age with a diagnosis of CD. They must also have previously failed or currently be failing with immunosuppresant treatments (azathioprine, 6-mercaptopurine or methotrexate).

CNTO1275CRD3002: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease.

The goal of this study is to evaluate the efficacy of Ustekinumab compared with placebo to induce response in patients with moderately to severly active CD. 

Ustekinumab is an antibody that targets interleukin-12 and interleukin-23, which are proteins that cause inflammation in the small bowel and colon. Blocking interleukin-12 and interleukin-23 is the proposed mechanism of action. 

Patients must be 18 years of age or older and have Crohn’s disease or fistulizing Crohn’s disease of at least three months duration.

IM133-005: A Phase IIb, Double-Blind, Randomized, Placebo-Controlled Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn’s Disease.

The goal of this study is to compare the efficacy of BMS-9454429 versus placebo for induction of clinical remission at week 8 (IP-57).

BMS-945429 has established efficacy in treatment of patients with RA based on its anti-inflammatory activity. BMS-945429 may also be expected to have efficacy in other chronic inflammatory diseases such as CD. In CD, blocking IL-6 with BMS-954429 may theoretically be associated with improvement of chronic inflammation in the GI tract as well as other potential benefits.

Patients must be 18 years of age or older and have moderate to severe CD. Patients must be intolerant to one or more of the following treatments:

• Oral prednisone, immunosuppressants or/and approved anti-TNF  have dependence to: oral prednisone or immunosuppressants.