Clinical trial NCT01194219: Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 844
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 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.


Eligibility criteria: 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

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
timeFrame: 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
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline
timeFrame: Baseline to Week 16
measure: Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline to Week 16
measure: Kaplan Meier Estimate of Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase
timeFrame: Week 32 to Week 52
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
timeFrame: Week 0 to Week 16; mean duration of exposure was 14.8 weeks and 15.0 weeks for subjects randomized to placebo and apremilast respectively.
measure: Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
timeFrame: Week 0 to Week 260; mean exposure to apremilast 30 mg BID during the Apremilast-exposure Period up to Week 260 was 97.83 weeks
measure: Number of Participants With a Psoriasis Flare or Rebound During the Placebo-Controlled Phase
timeFrame: Weeks 0 to Week 16
measure: Number of Participants With a Psoriasis Flare or Rebound During the During the Apremilast-exposure Period Through Week 260
timeFrame: Week 0 to Week 260
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.