A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life. (EMBRACE)
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|ClinicalTrials.gov Identifier: NCT03774875|
Recruitment Status : Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
This is a Phase 4, multi-center, randomized, placebo-controlled, double-blind study of the impact of apremilast on quality of life, efficacy, and safety in subjects with manifestations of plaque psoriasis and impaired quality of life.
Approximately 255 subjects will be randomized 2 (apremilast):1 (placebo) in approximately 6 to 10 countries in Western Europe. Subjects will be block-randomized equally to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). If subjects present with multiple manifestations, they will be allocated to the manifestation which is most severe, as determined by the subject.
However, all manifestations will be assessed for efficacy at each study visit.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Apremilast (CC-10004) Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life.|
|Estimated Study Start Date :||February 10, 2019|
|Estimated Primary Completion Date :||June 19, 2020|
|Estimated Study Completion Date :||May 26, 2021|
Experimental: Apremilast 30 mg twice daily
Subjects will take oral tablets of apremilast for up to 52 weeks (30 mg twice daily).
Drug: Apremilast (CC-10004)
This study will randomize subjects to either apremilast 30 mg BID or placebo comparator in a 2:1 ratio, respectively. Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk 16 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles.
Other Name: Otezla
Placebo Comparator: Placebo followed by Apremilast 30mg twice daily
Subjects will take placebo for 16 weeks. After Week 16, subjects will be switched to receive apremilast (30 mg twice daily) until Week 52.
Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily for 16 weeks.
Drug: Apremilast (CC-10004)
Beginning at Week 16 and after a 5-day titration with apremilast, subjects initially randomized to placebo will be switched to receive apremilast 30 mg BID for 36 weeks (52 weeks total). Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles
- Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [ Time Frame: Week16 ]Dermatology Life Quality Index (DLQI)
- Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [ Time Frame: Week 32 and 52 ]Dermatology Life Quality Index (DLQI)
- Mean change from baseline in DLQI [ Time Frame: Week 16, 32 and 52 ]Dermatology Life Quality Index (DLQI)
- Mean change from baseline in Whole Body Itch NRS score [ Time Frame: Week 16, 32 and 52 ]Whole Body Itch Numeric Rating Scale (NRS)
- Mean change from baseline in skin discomfort/pain VAS [ Time Frame: Week 16, 32 and 52 ]Skin Discomfort/Pain Visual Analog Scale (VAS)
- Mean percent change in BSA affected by psoriasis [ Time Frame: Week 16, 32 and 52 ]Body Surface Area (BSA)
- Proportion of subjects who achieve PBI score of ≥ 1 [ Time Frame: Week 16, 32 and 52 ]Patient Benefit Index (PBI)
- Proportion of subjects who achieve PASI < 3 [ Time Frame: Week 16, 32 and 52 ]Psoriasis Area Severity Index (PASI)
- Mean percent change from baseline in EQ-5D score [ Time Frame: Week 16 and 52 ]European Quality of Life 5- Dimension (EQ-5D)
- Mean change in WPAI domain scores [ Time Frame: Week 16 and 52 ]Work Productivity and Activity Impairment Questionnaire (WPAI)
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): NCT03774875
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Study Director:||Priscila Nakasato, MD||Celgene|