Back to Search Results
Study Complete
Sponsor ID
CC-10004-PSOR-025

An Efficacy and Safety study of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital PsoriasisDISCREET

Sponsor ID
CC-10004-PSOR-025
Clinicaltrials.gov ID
NCT03777436
EUCTIS ID
N/A
EudraCT ID
2018-002608-15
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
289
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects with a modified sPGA-G score of

Timeframe: up to week 16

Secondary Outcome Measures

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

Timeframe: Up to week 16

Proportion of subjects with at least a 4-point improvement in

Timeframe: Up to week 16

Change from baseline in affected BSA at Week 16

Timeframe: Up to week 16

Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

Timeframe: Up to week 16

Change from baseline in Genital Psoriasis Symptoms Scale (GPSS)total score and individual item scores at Week 16

Timeframe: Up to week 16

Study Documents

Plain Language Summary of Results
Available Language(s): English, Spanish (United States), Italian, French (Canadian), Dutch (Belgium), French, French (Belgium), German
Download Document(s)

Locations

Location
Status
Contact Us
Location
Ospedali Riuniti di Ancona
Ancona, Italy, 60020
Status
Recruiting
Location
Oakview Dermatology
Athens, OH, United States, 45701
Status
Recruiting
Location
Austin Institute for Clinical Research
Pflugerville, TX, United States, 78660
Status
Recruiting
Location
ISA - Interdisciplinary Study Association GmbH
Berlin, Germany, 10789
Status
Recruiting
Location
University of Alabama at Birmingham
Birmingham, AL, United States, 35233
Status
Recruiting
Location
Universitaetsklinikum Bonn
Bonn, Germany, 53127
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Feb 2019 - Sep 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF. 3. Subject must have a diagnosis of moderate or severe psoriasis of the genital area at Screening and Baseline. 4. Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline. 5. Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline. 6. 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. 7. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 8. Subject must meet laboratory criteria
    Exclusion Criteria:
    The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study. 2. 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. 3. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening. 4. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 5. 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. 6. 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 7. Subject had prior treatment with apremilast.