Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Apremilast; Placebo
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Inflammatory Bowel Disease

Summary:

      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).
    

Eligibility criteria:

        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 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.