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

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ClinicalTrials.gov Identifier: NCT03123471
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast Other: Placebo Phase 3

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 will be switched to (or continue with) apremilast 30 mg BID 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Place-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004 in Subjects With Moderate to Sever Plaque Psoriasis of the Scap)
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : August 13, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: 16-week Placebo and Apremilast 30 mg BID
Weeks 0 to 16: Double-blind, Placebo-controlled Treatment Phase: Apremilast 30 mg Twice Daily (BID) or placebo BID
Drug: Apremilast
Apremilast 30 mg Twice Daily (BID)

Other: Placebo
Placebo Twice Daily (BID)

Experimental: Apremilast Extension Phase
Weeks 16 to 32: Apremilast Extension Phase: Apremilast 30 mg Twice Daily (BID).
Drug: Apremilast
Apremilast 30 mg Twice Daily (BID)




Primary Outcome Measures :
  1. Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 [ Time Frame: Up to 16 weeks ]
    The ScPGA is a measurement of overall scalp involvement in plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).


Secondary Outcome Measures :
  1. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the whole body itch NRS score at Week 16 [ Time Frame: Up to 16 weeks ]
    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity

  2. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the scalp itch NRS score at Week 16 [ Time Frame: Up to 16 weeks ]
    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch

  3. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the whole body itch NRS score at Week 12 [ Time Frame: Up to 12 weeks ]
    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

  4. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the scalp itch NRS score at Week 12 [ Time Frame: Up to 12 weeks ]
    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

  5. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the whole body itch NRS score at Week 8 [ Time Frame: Up to 8 weeks ]
    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

  6. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the scalp itch NRS score at Week 8 [ Time Frame: Up to 8 weeks ]
    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

  7. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the whole body itch NRS score at Week 4 [ Time Frame: Up to 4 weeks ]
    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

  8. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the scalp itch NRS score at Week 4 [ Time Frame: Up to 4 weeks ]
    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

  9. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the whole body itch NRS score at Week 2 [ Time Frame: Up to 2 weeks ]
    The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

  10. Proportion of subjects with ≥4 point reduction (improvement) from baseline in the scalp itch NRS score at Week 2 [ Time Frame: Up to 2 weeks ]
    The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

  11. Change from baseline in Dermatology Life Quality Index total score at Week 16 [ Time Frame: Up to 16 weeks ]
    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

  12. Adverse Events (AEs) [ Time Frame: Up to 2 years ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 psoriasis 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 (IP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123471


  Show 45 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Yao Wang, MD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03123471     History of Changes
Other Study ID Numbers: CC-10004-SPSO-001
U1111-1194-1248 ( Registry Identifier: WHO )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Plaque Psoriasis
Scalp
Double-Blind
Efficacy
Safety
CC-10004
Apremilast
Otezla
Itch
Head

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents