Phase 2
N=185
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02087943 ↗Enrolled (actual)
185
Serious AEs
2.3%
Results posted
Dec 2016
Primary outcome: Primary: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. — -10.98; -25.99; -31.57 percent change — p=0.1308
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
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. |
-10.98; -25.99; -31.57 | 0.1308 |
| SECONDARY Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12. |
6.3; 3.4; 14.3 | 0.4938 |
| SECONDARY Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12 |
32.8; 31.0; 42.9 | 0.8589 |
| SECONDARY The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4 |
-4.83; -10.00; -9.00 | 0.5286 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period |
30; 36; 44; 8; 26; 27 | — |
| SECONDARY Number of Participants With TEAEs During the Apremilast Exposure Period |
49; 61; 29; 38; 1; 1 | — |
Summary
A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis
Eligibility Criteria
Inclusion Criteria
- Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
- Have a diagnosis of atopic dermatitis for ≥ 12 months.
- Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
- Meet the laboratory criteria as defined per protocol
- Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication
- Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication.
Exclusion Criteria
- Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
- Positive for hepatitis B surface antigen or hepatitis C antibody
- Pregnant or breast feeding
- History of allergy to any component of the study medication.
- Active skin infection requiring systemic antimicrobials at Baseline.
Data sourced from ClinicalTrials.gov (NCT02087943). 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.