Phase 2
N=170
Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02289417 ↗Enrolled (actual)
170
Serious AEs
7.0%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12 — 12.1; 31.6; 21.8 Percentage of Participants — p=0.0142
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apremilast (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12 |
12.1; 31.6; 21.8 | 0.0142 sig |
| SECONDARY Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12 |
46.6; 61.4; 67.3 | 0.1224 |
| SECONDARY Percentage of Participants Who Achieved an Endoscopic Remission at Week 12 |
3.4; 8.8; 7.3 | 0.2472 |
| SECONDARY Percentage of Participants Who Achieved an Endoscopic Response at Week 12 |
41.4; 73.7; 47.3 | 0.0005 sig |
| SECONDARY Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12 |
72.4; 84.2; 87.3 | 0.1388 |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12 |
19.0; 43.9; 27.3 | 0.0046 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12 |
46.6; 63.2; 67.3 | 0.0755 |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8 |
32.8; 47.4; 52.7 | 0.1167 |
| SECONDARY Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8 |
48.3; 64.9; 81.8 | 0.0758 |
| SECONDARY The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase |
31; 28; 36; 12; 13; 20 | — |
| SECONDARY The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period |
5; 0; 1 | — |
| SECONDARY The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52 |
60; 67; 8; 5; 6; 0 | — |
| SECONDARY The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase) |
16; 27; 1; 0; 4; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02289417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.