Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
• Placebo — DRUG

Study Details

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 Dates

First listed

Nov 13, 2014

Start date

Jan 8, 2015

Status verified

Apr 2020

Primary completion

Sep 25, 2017

Completion

Jun 3, 2019

Study Design

Enrollment

170 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 30 mg PO BID
  Apremilast 30 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks: * Participants who achieve at least a 20% decrease from baseline in the total Mayo score (TMS) will continue to receive apremilast 30 mg BID for an additional 40 weeks. (Wk 52) * Participants who do not achieve at least a 20% decrease from baseline in the TMS will receive apremilast 40 mg BID for an additional 40 weeks (Wk 52) After 52 weeks, participants who are eligible for the Extension Phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104)
• Experimental: Apremilast 40 mg PO BID
  Apremilast 40 mg by mouth (PO) twice a day (BID) for 12 weeks After 12 weeks, participants assigned to the 40 mg BID dose of apremilast at baseline will continue to receive apremilast 40 mg BID for an additional 40 weeks (Wk 52) After 52 weeks, participants who are eligible for the extension Phase will continue to receive apremilast 40 mg BID for an additional 52 weeks (Wk 104)
• Placebo Comparator: Placebo BID
  Identically matching placebo by mouth (PO) twice a day (BID) for 12 weeks. After 12 weeks all participants randomized to placebo at baseline will be re-randomized to receive apremilast 30 mg or 40 mg BID for an additional 40 weeks (Wk 52) After Wk 52, participants who are eligible for the extension phase will continue to receive the same dose of apremilast assigned at Wk 12 (30 mg BID or 40 mg BID) for an additional 52 weeks (Wk 104)

Primary Outcome Measure

Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12 [ Time Frame: Week 12 ]

Locations (25)

Find similar trials in Dothan, AL

Related Studies

• Improving the Quality of Care for Adults With Inflammatory Bowel Disease
  Enrolling By Invitation · Dartmouth-Hitchcock Medical Center · Los Angeles, California
• The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
  Recruiting · Stanford University · Palo Alto, California
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
  PHASE1/PHASE2 · Recruiting · Children's Hospital Medical Center, Cincinnati · Hartford, Connecticut