An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (DISCREET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03777436|
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : April 20, 2020
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 332 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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Apremilast Other: Placebo||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||February 19, 2021|
|Estimated Study Completion Date :||July 6, 2021|
Experimental: 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
Other Name: CC-10004, Otezla
Experimental: 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
Other Name: CC-10004, Otezla
- Proportion of subjects with a modified sPGA-G score of [ Time Frame: up to week 16 ]Modified Static Physician Global Assessment of Genitalia (modified sPGA-G)
- Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 [ Time Frame: Up to week 16 ]Static PGA (sPGA)
- Proportion of subjects with at least a 4-point improvement in [ Time Frame: Up to week 16 ]Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS)
- Change from baseline in affected BSA at Week 16 [ Time Frame: Up to week 16 ]Body Surface Area (BSA)
- Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Up to week 16 ]Dermatology Life Quality Index
- Change from baseline in Genital Psoriasis Symptoms Scale (GPSS)total score and individual item scores at Week 16 [ Time Frame: Up to week 16 ]Genital psoriasis symptoms scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777436
|Contact: Amgen Call Centeremail@example.com|