Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (ADVANCE)
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|ClinicalTrials.gov Identifier: NCT03721172|
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : April 17, 2019
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque 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|
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 :||574 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), COMPARED TO PLACEBO, IN SUBJECTS WTIH MILD TO MODERATE PLAQUE PSORIASIS|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||August 5, 2020|
|Estimated Study Completion Date :||December 23, 2020|
Experimental: Apremilast 30 mg or Placebo
Oral Apremilast 30 mg or placebo twice daily (BID) from Week 0 to Week 16
Apremilast, oral, twice daily
Placebo, oral, twice daily
Experimental: Apremilast 30 mg, extension
Apremilast 30 mg twice daily (BID) from Week 16 to Week 32
Apremilast, oral, twice daily
- Proportion of subjects with an sPGA score of clear (0) or almost clear (1) and with at least a 2- point reduction from baseline at Week 16. [ Time Frame: Up to week 16 ]Static Physician Global Assessment (sPGA) 0/1
- Proportion of subjects who improved ≥ 75% in BSA from baseline at Week 16. [ Time Frame: Up to week 16 ]Body Surface Area (BSA)
- Body Surface Area (BSA)changes [ Time Frame: Up to week 16 ]Change from baseline in affected BSA at Week 16.
- Psoriasis Area and Severity Index (PASI) [ Time Frame: Up to week 16 ]Change from baseline in total PASI score at Week 16
- Proportion of subjects with BSA ≤ 3% [ Time Frame: Up to week 16 ]Proportion of subjects who achieved BSA ≤ 3% for subjects with baseline BSA > 3% at Week 16.
- Proportion of subjects with ≥4-point reduction (improvement) from baseline in the whole-body itch NRS score at Week 16 among subjects with baseline whole body itch NRS ≥ 4. [ Time Frame: Up to week 16 ]Whole body itch numeric rating scale (NRS)
- Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 among subjects with baseline ScPGA score ≥ 2. [ Time Frame: Up to week 16 ]Scalp Physician Global Assessment (ScPGA)
- Dermatology Life Quality Index (DLQI) [ Time Frame: Up to week 16 ]Change from baseline in DLQI total score at Week 16
- Adverse Events (AEs) [ Time Frame: From signed the informed consent until at least 28 days after completion of study treatment ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721172
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
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|Study Director:||Yao Wang, MD||Celgene Corporation|