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

Last updated: April 28, 2020
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Rosacea

Skin Wounds

Warts

Treatment

N/A

Clinical Study ID

NCT03123471
CC-10004-SPSO-001
U1111-1194-1248
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 consentdocument

  • Be willing and able to adhere to the study visit schedule and other protocolrequirements.

  • Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening andbaseline

  • Must be a candidate for phototherapy and/or systemic therapy for either body or scalppsoriasis 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 onmedical history, physical examination, 12-lead electrocardiogram (ECG), clinicallaboratories, and urinalysis

  • Must meet laboratory criteria

  • Females of childbearing potential (FCBP)* must have a negative pregnancy test atscreening and baseline. While on investigational product (IP) and for at least 28 daysafter taking the last dose of investigational product, FCBP who engage in activity inwhich conception is possible - must use one of the approved contraceptive** optionsdescribed below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral,injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tuballigation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom ornonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUSone additional barrier method: (a) diaphragm with spermicide; (b) cervical cap withspermicide; or (c) contraceptive sponge with spermicide.

*A female of childbearing potential is a sexually mature female who 1) has not undergone ahysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgicalremoval of both ovaries) or 2) has not been postmenopausal for at least 24 consecutivemonths (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 thefemale subject is randomized into the study (for example, hormonal contraception should beinitiated at least 28 days before randomization).

Exclusion

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 thesubject 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 acquiredimmunodeficiency (eg, common variable immunodeficiency disease)

  • Active substance abuse or a history of substance abuse within 6 months prior tosigning the informed consent form.

  • Bacterial infections requiring treatment with oral or injectable antibiotics, orsignificant viral or fungal infections, within 4 weeks of signing the informed consentform.

  • Malignancy or history of malignancy, except for treated (i.e., cured) basal cell orsquamous cell in situ skin carcinomas or treated (i.e., cured) cervicalintraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence ofrecurrence within 5 years of signing the informed consent.

  • Prior history of suicide attempt at any time in the subject's life time prior tosigning the informed consent and randomization, or major psychiatric illness requiringhospitalization within the last 3 years prior to signing the informed consent.

  • Psoriasis flare/rebound within 4 weeks of signing the informed consent form or betweenthe screening and baseline visits.

  • Topical therapy within 2 weeks prior to randomization; Conventional systemic therapyfor psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids onthe scalp within 2 weeks prior to randomization; Phototherapy treatment of body orscalp 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 5pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)

  • Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) lightsources

  • Prior treatment with apremilast

  • History of allergy or hypersensitivity to any components of the Investigationalproduct.

Study Design

Total Participants: 303
Study Start date:
May 16, 2017
Estimated Completion Date:
January 09, 2019

Study 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.

Connect with a study center

  • Institute for Skin Advancement

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Kirk Barber Research

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Chih-Ho Hong Medical, Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • New Lab Clinical Research

    Saint Johns, Newfoundland and Labrador A1C 2H5
    Canada

    Site Not Available

  • Eastern Canada Cutaneous Research Associates Ltd

    Halifax, Nova Scotia B3H 1Z4
    Canada

    Site Not Available

  • Lynderm Research

    Markham, Ontario L3P1X2
    Canada

    Site Not Available

  • North Bay Dermatology Center

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Skin Center for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Centre For Dermatology and Cosmetic Surgery

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • The Toronto Dermatology Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • K. Papp Clinical Research

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • XLR8 Medical Research

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Tien Q. Nguyen MD Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • San Luis Dermatology and Laser Clinic

    San Luis Obispo, California 93405
    United States

    Site Not Available

  • University of Connecticut

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Florida Academic Centers Research and Education

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • International Dermatology Research

    Miami, Florida 33144
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Dermatologic Surgery Specialists, P.C.

    Macon, Georgia 31217
    United States

    Site Not Available

  • MedaPhase INC

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Forefront Dermatology

    Carmel, Indiana 46032
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Dermatology and Advanced Aesthetics

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Lawrence Green, MD, LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Central Dermatology

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Skin Specialists, PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Forest Hills, New York 11375
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • San Luis Dermatology and Laser Clinic

    Dayton, Ohio 45408
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Austin Dermatology Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Modern Research Associates PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Virginia Clinical Research Inc

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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