Overview

This trial is active, not recruiting.

Condition parapsoriasis
Treatments apremilast, placebo
Phase phase 4
Sponsor Celgene Corporation
Start date April 2015
End date February 2016
Trial size 197 participants
Trial identifier NCT02425826, CC-10004-PSOR-012

Summary

This study will evaluate the clinical efficacy, patients quality of life, satisfaction, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in subjects with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects will receive treatment with either apremilast 30 mg tablets orally twice daily (BID), or matched placebo tablets orally twice daily (BID)
apremilast CC-10004, Otzela
placebo
(Experimental)
All subjects will be switched to (or continue with) apremilast 30 mg twice daily (BID) at Week 16. All subjects will maintain this dosing up to Week 52.
apremilast CC-10004, Otzela

Primary Outcomes

Measure
The primary outcome measure is the mean percentage change from baseline in the product of body surface area (BSA) (%) multiplied by the static Physician's Global Assessment (sPGA) at Week 16
time frame: Up to week 16

Secondary Outcomes

Measure
Dermatology Life Quality Index (DLQI) total score at Week 16
time frame: Up to 16 weeks
Percent of subjects achieving 0 (clear) or 1 (almost clear) on static Physician's Global Assessment (sPGA) scale at Week 16
time frame: Up to week 16
Percent of subjects achieving 0 (clear) or 1 (very mild) on Patient Global Assessment (PtGA) scale at Week 16
time frame: Up to week 16
Mean change from baseline in Pruritus Visual Analog Scale (VAS) at Weeks 1 and 16
time frame: Up to week 16
In subjects with scalp psoriasis at baseline, proportion of subjects with scalp Physician's Global Assessment (ScPGA) 0 (clear) or 1 (minimal) at Week 16
time frame: Up to week 16
Treatment Satisfaction Questionnaire for Medication (TSQM) at Weeks 16
time frame: Up to weeks 16
Treatment Satisfaction Questionnaire for Medication (TSQM) at Weeks 52
time frame: Up to weeks 52
Mean percentage change from baseline in psoriasis area severity index (PASI) at Week 16
time frame: Up to week 16
Subjects who achieve a PASI 50 at Week 16
time frame: Up to week 16
Subjects who achieve a PASI 75 at Week 16
time frame: Up to week 16
Mean percentage change from baseline in the product of BSA (%) x sPGA at Week 52
time frame: Up to week 52
Adverse Events (AEs)
time frame: 56 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Males or females, ≥ 18 years of age at the time of signing the informed consent document. 2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent. 5. Have moderate plaque psoriasis at screening and baseline as defined by 1. BSA (Body Surface Area)5% to 10% and 2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale 6. Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. 7. No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis. 8. 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. 9. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product Exclusion Criteria: 1. Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled. 2. 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. 3. Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis. 4. 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. 5. Pregnant or breast feeding. 6. Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent. 7. Malignancy or history of malignancy, except for: 1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; 2. treated (ie, 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. 8. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization. 9. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 10. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study. 11. Prior treatment with apremilast.

Additional Information

Official title A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Description This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis. Approximately 219 subjects will be randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Subjects randomized to the apremilast treatment group will receive apremilast 30 mg tablets orally twice daily for 52 weeks. Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily for 16 weeks. Beginning Week 16, subjects initially randomized to placebo will be switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total). Study will enroll adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments. The primary efficacy endpoint will be assessed at Week 16 and will be the mean percentage change from baseline in the product of body surface area (BSA) (%) and static Physician's Global Assessment (sPGA).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.