Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily \[BID\] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

Key facts

Study ID

NCT02289417

Run by

Amgen

People needed

170

Starts

2015-01-08

Expected to finish

2019-06-03

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must satisfy the following criteria to be enrolled in the study:
• Male or female aged 18 and over at the time of signing the informed consent.
• Must understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
• Diagnosis of ulcerative colitis (UC) with a duration of at least 3 months prior to the Screening Visit..
• Total Mayo Score (TMS) ≥ 6 to ≤ 11 (range: 0-12) at baseline, prior to randomization in the study.
• Endoscopic subscore ≥ 2 (range: 0-3) on the Mayo score prior to randomization in the study.
• Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
• Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
• Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
• Clinical signs suggestive of fulminant colitis or toxic megacolon.
• Prior use of any tumor necrosing factor (TNF) inhibitor (or any biologic agent).
• Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
• Use of intravenous (IV) corticosteroids within 2 weeks of the Screening Visit.
• Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
• Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
• History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study.

Where it is running

• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Precision Clinical Research, LLC — Lauderdale Lakes, Florida, United States
• Pharmax Research Clinic, Inc. — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• UMass Medical Center — Worcester, Massachusetts, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Center for Digestive Health Research — Troy, Michigan, United States
• Gastrointestinal Associates PA — Flowood, Mississippi, United States
• NYU Langone Long Island Clinical Research Associates — Great Neck, New York, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• Quality Medical Research — Nashville, Tennessee, United States
• Digestive Research Center/ Gastroenterology Consultants of San Antonio — Live Oak, Texas, United States
• Digestive Health Specialist of Tyler — Pasadena, Texas, United States
• San Antonio Gastroenterology — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Harborview Medical Center — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Digestive Health Specialists of The Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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