Clinical Trials for Inflammatory Bowel Diseasea at UC San Diego Health System

Gastroenterology & Digestive Diseases

Current IBD Clinical Trials

Ulcerative Colitis Clinical Trials

ABS 4986g: Phase II randomized, double-blind placebo-controlled study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis (UC).

  • The primary objective of this study is to evaluate the efficacy of different doses of rhuMAb Beta7 compared with placebo in patients with moderate to severe ulcerative colitis (UC)
  • RhuMAb Beta7 (PRO145223) is a humanized IgG1 monoclonal antibody targeting the ß7 subunit of the a4ß7 and aEß7 integrin heterodimer receptors. Inhibition of trafficking of leukocytes to the gut through the antibody binding of a4ß7 and inhibition of retention of leukocytes in the intraepithelial lining of the gut through the antibody binding of aEß7 are proposed mechanisms for significantly modifying the inflammatory process in UC.
  • Patients must be 18-75 years of age. They must have a diagnosis of moderate to severe UC.

IM 129-005: Phase IIb randomized, placebo-controlled study to evaluate the clinical efficacy and safety of induction and maintenance therapy with BMS-936557 in patients with active ulcerative colitis (UC).

  • The primary objective of this study is to compare the efficacy of BMS-936557 versus placebo for the induction of clinical remission
  • Patient must be at least 18 years old with a clinical diagnosis of moderate to severely active ulcerative colitis confirmed by endoscopic evidence. They cannot have a diagnosis of Crohn’s disease or indeterminate colitis.

To learn more about these studies or to see whether you qualify, please contact ibdresearch@ucsd.edu or call 858-657-5279.

Crohn’s Disease Clinical Trials

GA 28084: Observational multicenter study in patients with Crohn’s disease for characterization of magnetic resonance enterography assays for assessment of disease activity protocol.

  • The overall aim of this study is to assess the feasibility of implementing magnetic resonance enterography (MRE) for use in evaluating disease status in Crohn's disease (CD) patients in a global setting. There will be no therapeutic intervention in this study. Patients will continue on their prescribed medication at a stable dose throughout the short duration of the study.
  • Patients must be = 18 years of age and have a confirmed histologic diagnosis of CD with a disease duration of = 12 weeks.

GSK 151: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of GSK1605786A in the treatment of subjects with moderately-to-severely active Crohn’s disease (CD).

  • The primary objective is to assess the efficacy of GSK1605786A compared with placebo as an induction therapy in subjects with moderately-to-severely active Crohn’s disease over 12 weeks.
  • GSK 1605786A is an orally administered small molecule chemokine receptor agonist which specifically blocks the migration of gut specific T cells, which is selectively home to the intestine.
  • Patients must be = 18 years of age with a diagnosis of Crohn’s disease for > 4 months duration with small bowel and/or colonic involvement.

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 primary objective of this study is to determine the number of subjects that experience a decrease in CDAI (Crohn’s Disease Activity Index) of at least 70 points by the week 8 or week 12 assessment.
  • PF-00547659 is a fully human IgG2k monoclonal antibody that binds to recombinant human MAdCAM to reduce lymphocyte homing to the gut and GI inflammation. MAdCAM plays a role in gut immune surveillance, and also appears to facilitate excessive lymphocyte infiltration under conditions of chronic gastrointestinal inflammation.
  • Patients must be between 18-75 years of age. They must also have active moderate to severe ileal (terminal ileum), ileocolonic, or colonic CD (CDAI scores 220-450), despite use of stable doses of Mesalamine (5-ASAs), and/or immunosuppressants (AZA, 6-MP and methotrexate (MTX)).
  • Patients must also be inadequate responders or intolerant to immunosuppressants.

C87075 (SECURE): A non-interventional long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia) for Crohn’s Disease.

  • The objective of this registry study is to track safety outcomes of patients who have taken Cimzia for the treatment of Crohn’s disease compared to a non-Cimzia control population.
  • Patients must have documented Crohn’s disease and cannot have taken Cimzia for = 6 months prior to going on study.

CNTO1275CRD3002: Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety and efficacy of Ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease.

  • The primary objective of this study is to evaluate the efficacy and safety of IV induction regimens of Ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease.
  • Ustekinumab is a fully human immunoglobulin G1 (IgG1k) monoclonal antibody (mAb) to human interleukin (IL)-12/23p40 that binds with a high affinity to human IL-12 and IL-23. Ustekinumab prevents IL-12 and IL-23 bioactivity by preventing their interaction with their cell surface IL12Rß1 receptor protein. Abnormal regulation of IL-12 and IL-23 has been associated with multiple immune-mediated diseases; including inflammatory bowel disease; and binding the IL-12/23p40 subunit may provide effective therapy in Crohn’s Disease.
  • Patients must be = 18 years of age and have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.

CNTO1275CRD3001: A 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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy.

  • The primary objective of this study is to evaluate the safety and efficacy of IV induction regimens of Ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease that have failed or are intolerant to one or more tumor necrosis factor (TNF) antagonist therapies.
  • Ustekinumab is a fully human immunoglobulin G1 (IgG1k) monoclonal antibody (mAb) to human interleukin (IL)-12/23p40 that binds with a high affinity to human IL-12 and IL-23. Ustekinumab prevents IL-12 and IL-23 bioactivity by preventing their interaction with their cell surface IL12Rß1 receptor protein. Abnormal regulation of IL-12 and IL-23 has been associated with multiple immune-mediated diseases; including inflammatory bowel disease; and binding the IL-12/23p40 subunit may provide effective therapy in Crohn’s Disease.
  • Patients must be = 18 years of age and have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy. Patients must also have received Infliximab, Adalimumab, or Certolizumab Pegol at a dose approved for the treatment of Crohn’s disease and did not respond initially

PREVENT: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
*UC San Diego researchers have led other clinical trials in the approval of Remicade for the treatment of Crohn’s disease.

  • The primary objective of this study will be to compare the efficacy of Remicade (Infliximab) with that of placebo in the prevention of clinical recurrence of CD prior to or at Week 76 in patients who are at an increased risk of active CD recurrence following ileocolonic resection.
  • Remicade is approved for the treatment of patients with Crohn’s Disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and ulcerative colitis. It is administered by intravenous (IV) infusion and is a chimeric (human murine) Immunoglobulin G1 kappa monoclonal antibody that binds to and neutralizes soluble and transmembrane forms of tumor necrosis factor alpha and inhibits the binding of TNFa with its receptors.
  • Patients must be = 18 years of age and have a documented diagnosis of CD confirmed by endoscopic, histologic, and/or radiologic studies prior to resection or by tissue obtained at resection.
  • Patient cannot have a history of latent or active TB prior to screening. Latent TB is allowed if treatment occurred 3 years prior to study onset.

To learn more about these studies or to see whether you qualify, please contact ibdresearch@ucsd.edu or call 858-657-5279.