Translate
Giving
Menu
Search

IBD Clinical Trials

Contact Coordinator

Call 858-657-5279

Ulcerative Colitis Trials | Crohn's Disease Trials

Biobank (All IBD Types)

UC San Diego Inflammatory Bowel Disease Center Patient Biobank

The purpose of this study is to establish a biobank of human blood, tissue and stool samples, images, and clinical data to be used in research intended to find out more about inflammatory bowel disease (IBD), especially Crohn’s disease and ulcerative colitis.

The biobank will allow scientists to perform future studies that may allow us to learn more about IBD in order to improve the care provided.

Patients must be 18 years of age and diagnosed with IBD by their provider.


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 and 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 ulcerative colitis at week eight 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, intolerance, or loss of response to one of the following:

  • Immunomodulators
  • Anti-TNF agents

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 have active mild to moderate ulcerative colitis. Patients must be currently receiving mesalamine for at least six weeks prior to receiving study drug.

CNTO148UCO2001: A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis.

The purpose of this study is to evaluate the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis.

Golimumab is classified as a TNF inhibitor and is approved in the United States, European Union, and Canada for the treatment of ulcerative colitis. Studies have shown that people respond differently to treatment with TNF inhibitors and some people may not respond to treatment. Tests which could predict the likelihood of response to golimumab prior to treatment would benefit people with ulcerative colitis.

Patients must be at least 18 years of age with moderate to severe ulcerative colitis. Patients must NOT have received the following concomitant or previous medical therapies: biologic therapy targeted at tumor necrosis factor alpha (e.g., infliximab, adalimumab, golimumab, etanercept, cetrolizumab); natalizumab within 12 months; agents that deplete B- or T-cells within 12 months; cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks; vedolizumab within 8 weeks.

54781532UCO2001: A Study of Safety and Effectiveness of JNJ-54781532 in Patients with Moderately to Severely Active Ulcerative Colitis.

The purpose of this study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis.

JNJ-54781532 is an investigational oral immunosuppressant that acts by inhibiting Janus kinase (Jak), with moderate selectivity for JAK3.

Patients must be at least 18 years old and have moderately to severely active ulcerative colitis. Subjects must have demonstrated an inadequate response or have failed to tolerate at least one of the following conventional therapies: oral corticosteroids, the immunomodulators azathioprine or 6-mercaptoputrine, or anti-tumor necrosis factor alpha therapy. Subjects having demonstrated corticosteroid dependence are also eligible for entry into the study.


Crohn's Disease Clinical Trials

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