Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments apremilast, placebo, topical treatments or phototherapy
Phase phase 3
Sponsor Celgene Corporation
Start date September 2010
End date December 2012
Trial size 844 participants
Trial identifier NCT01194219, CC-10004-PSOR-008

Summary

This study evaluated the effects of an called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study was to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study was able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Apremilast 30 mg by mouth (PO) twice a day (BID). Participants initially randomized to apremilast 30 mg BID, and who were able to demonstrate a Psoriasis Area Severity Index (PASI)-75 response at week 32 were randomized (1 to1) to either apremilast 30 mg BID or oral placebo (until effect is lost). At relapse/loss of response to therapy (the time effect is lost), participants were treated with apremilast 30 mg BID for the duration of their participation in the study. Non-responders or partial responders (PASI response <75) received additional topical therapies or phototherapy beginning at Week 32.
apremilast CC-10004
placebo
Identical matching placebo
topical treatments or phototherapy Corticosteroid creams
At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.
(Placebo Comparator)
Identically matching placebo by mouth twice a day (BID) during the placebo controlled phase from weeks 0 through 16. At week 16, placebo participants were switched to active apremilast 30mg BID and maintained this dosing through week 32. At week 32, participants were evaluated and the partial responders (PASI-50 to PASI-74) and non-responders (< PASI-50) had the option of adding topical therapies and/or phototherapy to their treatment regimen.
apremilast CC-10004
placebo
Identical matching placebo
topical treatments or phototherapy Corticosteroid creams
At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.

Primary Outcomes

Measure
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline
time frame: Baseline to Week 16

Secondary Outcomes

Measure
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline
time frame: Baseline to Week 16
Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16
time frame: Baseline and Week 16
Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16
time frame: Baseline to Week 16
Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline
time frame: Baseline to Week 16
Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16
time frame: Baseline and Week 16
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
time frame: Baseline to Week 16
Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
time frame: Baseline to Week 16
Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline at Week 16 From Baseline
time frame: Baseline to Week 16
Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase
time frame: Week 32 to Week 52
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
time frame: Week 0 to Week 16
Number of Participants With a Psoriasis Flare or Rebound During the Placebo Controlled Phase
time frame: Weeks 0 to Week 16

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. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening a. Have moderate to severe plaque psoriasis at Screening and Baseline 3. Must meet all laboratory criteria 4. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication 5. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication. Exclusion Criteria: 1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease. . 2. Pregnant or breast feeding 3. History of allergy to any component of the study drug 4. Hepatitis B surface antigen positive at Screening 5. Anti-hepatitis C antibody positive at Screening 6. Active tuberculosis (TB) or a history of incompletely treated TB 7. Clinically significant abnormality on 12-Lead Electrocardiogram (ECG) at Screening 8. Clinically significant abnormal chest x-ray 9. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency 10. Active substance abuse or a history of substance abuse within 6 months prior to Screening 11. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening 12. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years) 13. Psoriasis flare or rebound within 4 weeks prior to Screening 14. Evidence of skin conditions that would interfere with clinical assessments 15. Topical therapy within 2 weeks of randomization 16. Systemic therapy for psoriasis within 4 weeks prior to randomization 17. Use of phototherapy within 4 weeks prior to randomization (ie, Ultraviolet B (UVB), psoralen and ultraviolet A (PUVA) 18. Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization 19. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization 20. Use of any investigational drug within 4 weeks prior to randomization 21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources 22. Prior treatment with apremilast

Additional Information

Official title A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Celgene Corporation.