An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
NCT ID: NCT03777436
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
289 participants
INTERVENTIONAL
2019-02-11
2022-02-09
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Apremilast
Oral
Placebo
Oral
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
Apremilast
Oral
Interventions
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Apremilast
Oral
Placebo
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
First OC Dermatology
Fountain Valley, California, United States
Clinical Science Institute
Santa Monica, California, United States
Glick Skin Institute
Margate, Florida, United States
International Dermatology Research, Inc
Miami, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Adult and Pediatric Dermatology
Overland Park, Kansas, United States
ActivMed Practices and Research Inc
Beverly, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
J Woodson Dermatology and Associates
Henderson, Nevada, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
ActivMed
Portsmouth, New Hampshire, United States
Stony Brook Dermatology Associates
Stony Brook, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Oakview Dermatology
Athens, Ohio, United States
Ohio State University Medical Center
Gahanna, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Center for Clinical Studies
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Virginia Clinical Research Inc
Norfolk, Virginia, United States
Bellevue Dermatology Clinic
Bellevue, Washington, United States
Dermatology Center for Skin Health
Morgantown, West Virginia, United States
Centre Hospitalier Universitaire Saint Pierre
Brussels, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
K Papp Clinical Research
Waterloo, Ontario, Canada
Dre Angelique Gagne-Henley M.D. Inc
Saint-Jérôme, Quebec, Canada
Skincare Studio
St. John's, , Canada
Hopital Claude Huriez CHRU Lille
Lille, , France
CHU de Nice Archet I
Nice, , France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
Pessac, , France
Larrey University Hospital
Toulouse, , France
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Hautklinik Universitatsklinikum Erlangen
Erlangen, , Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
Lübeck, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Presidio Ospedaliero della Misericordia
Grosseto, , Italy
Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore
LAquila, , Italy
Azienda Ospedaliera Di Padova
Padua, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina
Terracina, , Italy
Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, , Italy
GCM Medical Group, PSC
San Juan, , Puerto Rico
Countries
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References
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Merola JF, Parish LC, Guenther L, Lynde C, Lacour JP, Staubach P, Cheng S, Paris M, Picard H, Deignan C, Jardon S, Chen M, Papp KA. Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 Mar;90(3):485-493. doi: 10.1016/j.jaad.2023.10.020. Epub 2023 Oct 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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U1111-1224-6850
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-002608-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-10004-PSOR-025
Identifier Type: -
Identifier Source: org_study_id
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