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IBD Clinical Trials

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Call 858-657-5279

Ulcerative Colitis Trials | Crohn's Disease Trials

 

IBD Biobanks

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.

Predicting Response to Medical Therapy in IBD

The purpose of this study is to understand why some patients with IBD clinically respond to TNF inhibitors and other patients with IBD do not respond to TNF inhibitors. Colonic biopsies and blood will be obtained from patients with a clinical response to TNF inhibitors and from patients without clinical response to TNF inhibitors

First, gene expression from TNF responders and non-responders will be compared to help identify predictors of who will respond to this therapy, enabling the development of tests that will help to predict which patients with IBD are likely to benefit from treatment with TNF inhibitors and which are not. Then, intestinal biopsies will be used to develop systems to test potential efficacy of new medications in order to identify potential therapies that may benefit patients not responding to conventional TNF inhibitors.

This biobank study is conducted in collaboration with Takeda California.

FIT: Fecal immunochemical testing for quantifying disease activity in ulcerative colitis and Crohn’s disease: Identifying a ‘FIT for purpose’ clinical end-point)

Ulcerative colitis (UC) is a chronic condition of the lower intestines, or colon. It is associated with episodes of swelling and inflammation of the colon, which result in abdominal pain and bloody diarrhea. Currently, physicians rely heavily on performing colonoscopy to determine the severity of disease and most appropriate treatment. Colonoscopy is however, an invasive test and can sometimes be associated with an increased risk for complications requiring surgery. Fecal immunochemical testing, or FIT, is a lab based test that measures the amount of blood in a patients stool. Currently, FIT is used as an alternative to colonoscopy for colon cancer screening. Bloody diarrhea is one of the most common symptoms in UC and measuring the amount of blood in the stool may help determine how inflamed the colon is. FIT could therefore potentially be used as an alternative to colonoscopy for determining the severity of inflammation and most appropriate treatment. We plan to perform a research study where we test stool prior to colonoscopy with FIT and determine if FIT results correlate well with colonoscopy findings. The information from this study will help determine if FIT can be used as an alternative to colonoscopy in UC.

New Therapies and Biomarker Development in Crohn’s Disease

The purpose of this study is to try to identify tissue and blood biomarkers that would help predict response to therapies and ultimately to evaluate novel medications for Crohn’s disease.  Blood and intestinal biopsies will be obtained from patients with active Crohn’s disease. First, blood and tissue samples will be used to help identify biomarkers that will help predict response to therapies. Second, intestinal biopsies will be used to develop a system to test novel medications for the treatment of CD in order to identify potential new therapies that may be safer than existing therapies. Ultimately, the study will help develop new therapies for the treatment of CD.

To be eligible for the study the patient needs to have a diagnosis of CD with active symptoms. The patients cannot have impaired decisional capacity, bleeding diathesis and active diagnosis of colon cancer.

This biobank is conducted in collaboration with Janssen.


 

Ulcerative Colitis Clinical Trials

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

GA28950A Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis who are refractory to or Intolerant of TNF Inhibitors.

The objective for this study is to evaluate the efficacy of etrolizumab compared with placebo for the induction of remission in patients with UC as determined by the MCS at Week 14 and to evaluate the efficacy of etrolizumab compared with placebo for the maintenance of remission at Week 66 for randomized patients in remission at Week 14.

To be eligible for the study patients need to be between 18-80 years of age, have a diagnosis of UC established for at least 6 months, be intolerant or refractory to one or two TNF-inhibitors. The patients cannot have colonic resection, diagnosis of CD, past or present fistula or abdominal abscess.

Etrolizumab may enhance efficacy in UC and eliminate generalized immunosuppression by preferentially targetting trafficking to the gut rather than to other organs and tissues.

Etrolizumab is a humanized Mab based on the human IgG1 subgroup-III VH, κ subgroup-1 VL consensus sequences and was constructed using standard recombinant DNA techniques.

M14-033: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.

The purpose of this study is to evaluate the safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active ulcerative colitis.

To be eligible for the study, a patient must have active UC and be between 18-75 years of age and be diagnosed with UC for at least 90 days. Patients cannot have disease limited to the rectum and have a history of subtotal colectomy with ileorectosomy or colectomy with ileoanal pouch.

Adalimumab is a recombinant human monoclonal antibody containing only human peptide sequences. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system.

RPC01-3101: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintanenca Therapy for Moderate to Severe Ulcerative Colitis.

The purpose of this study is to demonstrate the efficacy of RPC1063 versus placebo on induction in clinical remission.

To be eligible for the study, patients will have to be 18-75 years old and have had a UC diagnosis for at least 3 months. Patient must  be receiving treatment with at least 1 of the following therapies and must continue on these therapies during Induction: Oral aminosalicylates, prednisone, budesonide.

Patients cannot have severe extensive colitis as evidenced by physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of Baseline or current/recent evidence of fulminant colitis, toxic megacolon, or bowel perforation.

RPC1063 is a small molecule compound that potently activates the S1P1R and the S1P5 receptor.

GS-US-395-1100: A Combined Phase 2/3, Double-blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis.

The purpose of this study is to evaluate the efficacy of GS-5745 to induce clinical remission and to evaluate the safety and tolerability of GS-5645.

GS-5745 is a fully humanized high-affinity monoclonal IgG4 antibody that is selective and a potent allosteric inhibitor of MMP9. In human UC, MMP9 expression is strongly induced and is associated with progressive disease. 

Patients must be between the ages of 18 to 75 years of age and should have a documented diagnosis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge.

Demonstrated at any time over the prior 5 years an inadequate clinical response or loss of response to, or intolerance to:
Corticosteroids, Immunomodulators, TNF Antagonists, Vedolizumab.


All IBD Studies

2013-01 OCEANIA:  Detection of Advanced Colorectal Neoplasia by Stool DNA in IBD.

The purpose of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients. Tissue diagnosis of CRC will be established by histopathology examination.

To be eligible for the study patients must be between 18-84 years of age and be a candidate for surveillance colonoscopy. The patient cannot have prior colorectal resection and IBD limited only to the rectum and without a concurrent PSC diagnosis.

  

Crohn's Disease Clinical Trials

M14-115 A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderatelty to Severely Active Crohn’s Disease and Evidence of Mucosal Ulceration.

The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission.

Patient need to be between 18- 75 years of age and have a CD diagnosis for at least 3 months. The patients need to have a CDAI score between 220 to 450 despite concurrent or prior treatment with at least one of the following: Oral corticosteroids, oral bedesonide, azathiprine, 6-MP or injectable MTX. Patient cannot have surgical bowel resection within the past 6 months or is planning any resection at any time point while enrolled in the study; symptomatic bowel stricture; abdominal or peri-anal abscess.

Adalimumab is a recombinant human monoclonal antibody containing only human peptide sequences. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system.

M13-740 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn’s Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.

The purpose of this study is to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics of ABT-494 following oral administration in subjects with moderately to severely active Crohn’s disease with a history of inadequate response to or intolerance to anti-TNF therapy.

To be eligible for the study patients must be between 18 and 75 years of age and have a diagnosis of ileal, colonic or ileocolonic Crohn’s disease for at least 3 months prior to entering the study. The patient must have inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent.
 
ABT-494 has demonstrated that inhibiting JAK1 with minimal impact of JAK2 is feasible at efficacious drug exposure levels. Thus, the enhanced selectivity of ABT-494 has the potential for an improved benefit/risk profile by mitigating JAK2 inhibitory effects on erythropoiesis and myelopoiesis.

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