IBD Clinical Trials

Ulcerative Colitis Trials | Crohn's Disease Trials

Ulcerative Colitis Clinical Trials

Dr. Sandborn talks about a promising new biologic for ulcerative colitis that can be self-administered by patients.

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 ulcerative clitis that has failed to respond 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 (UC).

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 one of the following therapies:

  • Oral aminosalicylates
  • Prednisone

NATRUL-3: A Phase III, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis

The goal of this study is to evaluate the efficacy of patients attaining clinical remission following 8 weeks of treatment of HMPL-004 compared to placebo in patients with mild to moderate ulcerative colitis.

HMPL-004 is an ethanol extract derived from the Andrographis paniculata plant (AP). HMPL-004 has been shown to inhibit inflammation and reduce colon damage.

Patients must be 18 years of age or older and active mild to moderate ulcerative colitis. Patients must be currently receiving mesalamine for at least 6 weeks prior to receiving study drug.


Crohn's Disease Clinical Trials

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 severely 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.

AMG 181: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease. 

The goal of this study is to evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn’s disease activity index (CDAI) remission (CDAI < 150) at week 8. 

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 and 65 years of age with moderate to severe Crohn’s disease. Patients must have demonstrated an intolerance or inadequate response to at least one of the following agents: 

  • Immunomodulators 
  • Anti-TNF agents 

 

B0151003: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders (Andante).

PF-04236921 is a fully human IgG2 monoclonal antibody that binds to human interleukin-6 (IL-6) protein and functions as a potent antagonist of IL-6 signaling. IL-6 is produced constitutively at low levels and is readily induced by infectious stimuli or inflammatory cytokines. IL-6 plays a key role in the intestinal inflammatory processes in IBD. There is increased production of IL-6 associated with the disease activity. 

Patients must be between 18 and 75 years of age with active moderate to severe Crohn’s disease. Patients must have failed or be intolerant to anti-TNFs.