Clinical trial NCT02087943: Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic Dermatitis
Keywords: Atopic Dermatitis
Atopic Eczema
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

1. Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
2. Have a diagnosis of atopic dermatitis for ≥ 12 months.
3. Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
4. Meet the laboratory criteria as defined per protocol
5. 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
6. 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:

1. Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
2. Positive for hepatitis B surface antigen or hepatitis C antibody
3. Pregnant or breast feeding
4. History of allergy to any component of the study medication.
5. Active skin infection requiring systemic antimicrobials at Baseline.

Primary outcomes:
measure: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: 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.
timeFrame: Baseline to Week 12
measure: Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12
timeFrame: Baseline to Week 12
measure: The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4
timeFrame: Baseline to Week 4
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
timeFrame: Baseline to Week 12
measure: Number of Participants With TEAEs During the Apremilast Exposure Period
timeFrame: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Northwestern Medical Faculty Foundation
state: Illinois
city: Lake Forest
country: United States
facility: Northwestern Medicine Lake Forest Hospital
state: Illinois
city: Louisville
country: United States
facility: Dermatology Specialists, PSC
state: Kentucky
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Department of Dermatology
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem LLC
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc
state: Virginia
city: Surrey
country: Canada
facility: Chih-Ho Hong Medical, Inc.
state: British Columbia
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd
state: Nova Scotia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre Dermatologique du Quebec Metropolitain
state: Quebec
city: Abashiri-shi, Hokkaido
country: Japan
facility: Kokubu Abashiri Dermatology Clinic
city: Chitose-shi, Hokkaido
country: Japan
facility: Asanuma Dermatology Clinic
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Fukuoka University Hospital Dermatology
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Hatamoto Dermatology Clinic
city: Iizuka-shi, Fukuoka
country: Japan
facility: Tashiro Clinic
city: Kitami-shi, Hokkaido
country: Japan
facility: Kokubu Dermatology
city: Kyoto-City
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Skin Clinic
city: Shinagawa-ku, Tokyo
country: Japan
facility: NTT Medical Center Tokyo
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5.