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 Genital Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- Apremilast
- Conditions
- Psoriasis
- Sponsor
- Amgen
- Enrollment
- 289
- Locations
- 52
- Primary Endpoint
- Percentage of Participants With a Modified sPGA-G Response at Week 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe).
Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
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 be randomly assigned to either 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. All subjects will maintain this dosing through Week 32. * Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- •Subject must have a diagnosis of moderate or severe psoriasis of the genital area at Screening and Baseline.
- •Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline.
- •Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline.
- •Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area.
- •Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
- •Subject must meet laboratory criteria
Exclusion Criteria
- •The presence of any of the following will exclude a subject from enrollment:
- •Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
- •Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
- •Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- •Subject has 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.
- •Subject has current or planned therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial
- •Subject had prior treatment with apremilast.
Arms & Interventions
Arm A- Apremilast with Placebo
Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
Intervention: Apremilast
Arm A- Apremilast with Placebo
Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
Intervention: Placebo
Arm B - Apremilast 30 mg
All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study
Intervention: Apremilast
Outcomes
Primary Outcomes
Percentage of Participants With a Modified sPGA-G Response at Week 16
Time Frame: Baseline and Week 16 of the Placebo-controlled Phase
The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling. A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.
Secondary Outcomes
- Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Affected Body Surface Area (BSA) at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline and Week 16 of the placebo-controlled phase)