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

NCT ID: NCT03123471

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2019-01-09

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.

Detailed Description

The study will consist of four phases:

• Screening Phase - up to 35 days
• Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following:

• apremilast 30 mg tablets orally BID or
• placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID
• Apremilast Extension Phase - Weeks 16 to 32

• All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32.
• Observational Follow-up Phase

• Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Apremilast 30 mg BID

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

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Apremilast 30 mg tablets BID from weeks 0 to 32.

Placebo

Intervention Type: OTHER

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

Placebo

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Apremilast

Apremilast 30 mg tablets BID from weeks 0 to 32.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

CC-10004

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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
• Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
• Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
• Prior treatment with apremilast
• History of allergy or hypersensitivity to any components of the Investigational product.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

Rogers, Arkansas, United States

Tien Q. Nguyen MD Inc

Fountain Valley, California, United States

Dermatology Research Associates

Los Angeles, California, United States

San Luis Dermatology and Laser Clinic

San Luis Obispo, California, United States

University of Connecticut

Farmington, Connecticut, United States

Florida Academic Centers Research and Education

Coral Gables, Florida, United States

International Dermatology Research

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Dermatologic Surgery Specialists, P.C.

Macon, Georgia, United States

MedaPhase INC

Newnan, Georgia, United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

DS Research

Louisville, Kentucky, United States

DS Research

Louisville, Kentucky, United States

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, United States

Lawrence Green, MD, LLC

Rockville, Maryland, United States

Central Dermatology

St Louis, Missouri, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Forest Hills Dermatology Group

Forest Hills, New York, United States

Icahn School of Medicine at Mount Sinai Medical Center

New York, New York, United States

Sadick Research Group

New York, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Wright State Physicians

Fairborn, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Austin Dermatology Associates

Austin, Texas, United States

Modern Research Associates PLLC

Dallas, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Clinical Research Inc

Norfolk, Virginia, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Kirk Barber Research

Calgary, Alberta, Canada

Institute for Skin Advancement

Calgary, Alberta, Canada

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Lynderm Research

Markham, Ontario, Canada

North Bay Dermatology Center

North Bay, Ontario, Canada

Skin Center for Dermatology

Peterborough, Ontario, Canada

Centre For Dermatology and Cosmetic Surgery

Richmond Hill, Ontario, Canada

The Toronto Dermatology Centre

Toronto, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

XLR8 Medical Research

Windsor, Ontario, Canada

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

Québec, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 37316690 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30747550 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1194-1248

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC-10004-SPSO-001

Identifier Type: -

Identifier Source: org_study_id