Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02289417
• Date of registration: 10/11/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis UC
• Scientific title: 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
• Date of first enrolment: January 8, 2015
• Target sample size: 170
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02289417
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: Apremilast

Primary Outcome(s)

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

Secondary Outcome(s)

The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase) [Time Frame: From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.]

Percentage of Participants Who Achieved an Endoscopic Remission at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8 [Time Frame: Week 8]

Percentage of Participants Who Achieved an Endoscopic Response at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8 [Time Frame: Week 8]

Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of = 1 at Week 12 [Time Frame: Week 12]

The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period [Time Frame: From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks]

The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase [Time Frame: From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks]

Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12 [Time Frame: Week 12]

The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52 [Time Frame: From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms]

Secondary ID(s)

2014-002981-64

CC-10004-UC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02289417