Status:
COMPLETED
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Lead Sponsor:
Amgen
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (modifi...
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 ta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT03777436
Start Date
February 11 2019
End Date
February 9 2022
Last Update
May 14 2024
Active Locations (52)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
First OC Dermatology
Fountain Valley, California, United States, 92708
3
Clinical Science Institute
Santa Monica, California, United States, 90404
4
Glick Skin Institute
Margate, Florida, United States, 33073