Clinical trial NCT03123471: A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Official title: A Phase 3, Multi-Center, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Scalp
Double-Blind
Efficacy
Safety
CC-10004
Apremilast
Otezla
Itch
Head
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 303
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: 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.

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.

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
timeFrame: Baseline to Weeks 2, 4, 6, 8 and 12
measure: Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
timeFrame: Baseline to Weeks 2, 4, 8 and 12
measure: Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline to Week 16
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
timeFrame: Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
measure: Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
timeFrame: Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
measure: Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
timeFrame: Week 0 to 32;
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen MD Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology and Laser Clinic
state: California
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education
state: Florida
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, P.C.
state: Georgia
city: Newnan
country: United States
facility: MedaPhase INC
state: Georgia
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Rockville
country: United States
facility: Lawrence Green, MD, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Surrey
country: Canada
facility: Chih-Ho Hong Medical, Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Markham
country: Canada
facility: Lynderm Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Center
state: Ontario
city: Peterborough
country: Canada
facility: Skin Center for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: Centre For Dermatology and Cosmetic Surgery
state: Ontario
city: Toronto
country: Canada
facility: The Toronto Dermatology Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.