Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

NCT02087943 | Completed Phase 2 Results DMC

• 1 other identifier: CC-10004-AD-001
• Study Type: interventional
• Target: 191
• Locations: 3 countries
• Sites: 31

Brief Summary

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Conditions

Dermatitis, Atopic Dermatitis

Keywords

Atopic Dermatitis; Atopic Eczema

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.

  EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

  Baseline to Week 12

Secondary Outcomes (5)

• 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.

  Baseline to Week 12

• Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12

  Baseline to Week 12

• The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4

  Baseline to Week 4

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period

  Baseline to Week 12

• Number of Participants With TEAEs During the Apremilast Exposure Period

  Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg

Study Arms (5)

Apremilast 40 mg

EXPERIMENTAL

Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

Drug: Apremilast

Apremilast 30 mg

EXPERIMENTAL

Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase

Drug: Apremilast

Placebo + Apremilast 40 mg

EXPERIMENTAL

Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

Drug: Apremilast; Drug: Placebo

Placebo + Apremilast 30 mg

EXPERIMENTAL

Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase

Drug: Apremilast; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

Drug: Placebo

Interventions

Apremilast DRUG

Orally twice a day (BID)

Also known as: CC-10004, Otezla

Apremilast 40 mg; Placebo + Apremilast 40 mg

Placebo DRUG

Orally twice a day (BID)

Placebo + Apremilast 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (31)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, 93309, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Advanced Medical Research

Atlanta, Georgia, 30342, United States

Location

Northwestern University Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Dermatology Specialists, PSC

Louisville, Kentucky, 40202, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

NYU Department of Dermatology

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

PMG Research of Winston-Salem LLC

Winston-Salem, North Carolina, 27103-3914, United States

Location

Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Virginia Clinical Research Inc

Norfolk, Virginia, 23507, United States

Location

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd

Halifax, Nova Scotia, B3H 1Z2, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

Centre Dermatologique du Quebec Metropolitain

Ste-Foy, Quebec, G1V 4X7, Canada

Location

Kokubu Abashiri Dermatology Clinic

Abashiri-shi, Hokkaido, 093-0016, Japan

Location

Asanuma Dermatology Clinic

Chitose-shi, Hokkaido, 066-0064, Japan

Location

Fukuoka University Hospital Dermatology

Fukuoka-shi, Fukuoka, 814-0180, Japan

Location

Hatamoto Dermatology Clinic

Fukuoka-shi, Fukuoka, 815-0075, Japan

Location

Tashiro Clinic

Iizuka-shi, Fukuoka, 820-0040, Japan

Location

Kokubu Dermatology

Kitami-shi, Hokkaido, 090-0832, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Sapporo Skin Clinic

Sapporo-shi, Hokkaido, 060-0063, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Related Publications (1)

• 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.

  PMID: 30528828 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: CelgeneCorp

amcclain@celgene.com

1-888-260-1599

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 14, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 7, 2020
• Results First Posted: December 12, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CA (6); JP (10); US (15)