Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:December 10, 2014
End Date:June 3, 2019

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A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

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 subjects with
active Ulcerative Colitis (UC).

Approximately 165 subjects (55 subjects per arm) will be randomized in a 1:1:1 ratio to
receive oral apremilast (30 mg BID or 40 mg BID), or identically appearing placebo BID for up
to 12 weeks, followed by 40 weeks of blinded treatment with apremilast (30 mg BID or 40 mg
BID).

At the end of the Blinded Active-treatment Phase (Week 52), subjects who have a Mayo
endoscopy score ≤ 1 will have the opportunity to participate in the Extension Phase. Subjects
participating in the Extension Phase will receive apremilast for an additional 52 weeks
(Weeks 52 to 104). With the implementation of Amendment 4, subjects entering the Extension
Phase will receive apremilast 30 mg BID. Subjects currently in the Extension Phase who are
receiving apremilast 40 mg BID will be switched to 30 mg BID at the next scheduled visit.

Inclusion Criteria:

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]).

Exclusion Criteria:

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 TNF inhibitor (or any biologic agent).

- Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.

- Use of 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.
We found this trial at
25
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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Bristol, Connecticut 06010
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Chesterfield, Michigan 48098
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Concord, New South Wales
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jackson, Mississippi 39202
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Lauderdale Lakes, Florida 33319
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Miami, Florida 33126
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Naples, Florida 34102
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Nashville, Tennessee 37211
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Pasadena, Texas 77505
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520 East Euclid Avenue
San Antonio, Texas 78212
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Troy, Michigan 48098
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Worcester, Massachusetts 01655
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