A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

NCT03123471 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CC-10004-SPSO-001U1111-1194-1248
• Study Type: interventional
• Target: 303
• Locations: 2 countries
• Sites: 45

Brief Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Scalp; Double-Blind; Efficacy; Safety; CC-10004; Apremilast; Otezla; Itch; Head

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline

  The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.

  Baseline to Week 16

Secondary Outcomes (8)

• Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16

  Baseline to Week 16

• Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16

  Baseline to Week 16

• Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase

  Baseline to Weeks 2, 4, 6, 8 and 12

• Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase

  Baseline to Weeks 2, 4, 8 and 12

• Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16

  Baseline to Week 16

Study Arms (2)

Apremilast 30 mg BID

EXPERIMENTAL

Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32

Drug: Apremilast; Other: Placebo

Placebo

PLACEBO COMPARATOR

Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)

Other: Placebo

Interventions

Apremilast DRUG

Apremilast 30 mg tablets BID from weeks 0 to 32.

Also known as: CC-10004

Apremilast 30 mg BID

Placebo OTHER

Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Apremilast 30 mg BID; Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Males or females, ≥ 18 years of age at the time of signing the informed consent document
• Be willing and able to adhere to the study visit schedule and other protocol requirements.
• Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline
• Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.
• Have moderate to severe plaque psoriasis at screening and baseline
• Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis
• Must meet laboratory criteria
• Females of childbearing potential (FCBP)\* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive\*\* options described below:
• Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• \*A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
• \*\* The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Other than psoriasis, history of any clinically significant uncontrolled disease.
• Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
• Pregnant or breast feeding
• Hepatitis B surface antigen positive at screening
• Anti-hepatitis C antibody positive at screening
• Active tuberculosis (TB) or a history of incompletely treated TB
• Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
• History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
• Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.
• Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
• Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
• Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
• Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
• Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization

Sponsors & Collaborators

• Amgen: lead

Study Sites (45)

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

Rogers, Arkansas, 72758, United States

Location

Tien Q. Nguyen MD Inc

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

San Luis Dermatology and Laser Clinic

San Luis Obispo, California, 93405, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Florida Academic Centers Research and Education

Coral Gables, Florida, 33134, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Dermatologic Surgery Specialists, P.C.

Macon, Georgia, 31217, United States

Location

MedaPhase INC

Newnan, Georgia, 30263, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

DS Research

Louisville, Kentucky, 40202, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Lawrence Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

Icahn School of Medicine at Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Austin Dermatology Associates

Austin, Texas, 78705, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

University of Utah

Salt Lake City, Utah, 84107, United States

Location

Virginia Clinical Research Inc

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Lynderm Research

Markham, Ontario, L3P1X2, Canada

Location

North Bay Dermatology Center

North Bay, Ontario, P1B 3Z7, Canada

Location

Skin Center for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Centre For Dermatology and Cosmetic Surgery

Richmond Hill, Ontario, L4B 1A5, Canada

Location

The Toronto Dermatology Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

Québec, G1V 4X7, Canada

Location

Related Publications (2)

• Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

  PMID: 37316690 DERIVED

• Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.

  PMID: 30747550 DERIVED

MeSH Terms

Conditions

Psoriasis; Pruritus

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne McClain, Senior Manager
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: May 16, 2017
• Primary Completion: August 13, 2018
• Study Completion: January 9, 2019
• Last Updated: May 13, 2020
• Results First Posted: September 4, 2019

Record last verified: 2020-04

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 (13); US (32)