Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments apremilast, placebo, topical or phototherapy therapy
Phase phase 3
Sponsor Celgene Corporation
Start date November 2010
End date December 2012
Trial size 413 participants
Trial identifier NCT01232283, CC-10004-PSOR-009

Summary

This study evaluated the effects of a study drug 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).

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
(Experimental)
Participants were initially randomized 1:1 and received apremilast 30 mg twice a day (BID).Participants maintained dosing through Week 32. At Week 32, responders, those with a Psoriasis Area Severity Index response -≥75 (PASI-75) and partial responders (≥PASI-50) were re-randomized 1:1 to apremilast 30 mg BID or matching placebo (treatment withdrawal). Participants could resume apremilast 30mg BID at the time of loss of response compared to baseline), and no later than Week 52. At Week 32, the non-responders (< PASI-50) had the option of adding topical therapies and/or phototherapy to their treatment regimen. Those re-randomized to apremilast 30mg BID continued dosing through week 52. At Week 52, participants continued treatment with apremilast 30 mg BID.
apremilast CC-10004
placebo
topical or phototherapy therapy Ultraviolet B
Topical therapies were low-potency or weak corticosteroids or phototherapies such as light therapy were added for non-responders at Week 32, (< PASI-50) and added to their treatment regimen.
(Placebo Comparator)
Participants were initially randomized to placebo, identically matching during Weeks 0-16. At Week 16, participants were switched and received apremilast 30 mg BID through Week 32. At Week 32, participants considered non-responders (< PASI-50) had the option of adding topical therapies and/or phototherapy to their apremilast treatment regimen. At Week 52, participants continued treatment with apremilast 30 mg BID.
apremilast CC-10004
placebo
topical or phototherapy therapy Ultraviolet B
Topical therapies were low-potency or weak corticosteroids or phototherapies such as light therapy were added for non-responders at Week 32, (< PASI-50) and added to their treatment regimen.

Primary Outcomes

Measure
Percentage of Participants Who Achieved at Least 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 the 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 and 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 and 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 Dermatology Life Quality Index (DLQI) Total Score at Week 16
time frame: Baseline and 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 at Week 16 From Baseline
time frame: Baseline to Week 16
Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase
time frame: Weeks 32 to Week 52
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
time frame: Baseline to Week 16
Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase
time frame: Week 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 - 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, UVB, 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.