An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

NCT03777436 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CC-10004-PSOR-025U1111-1224-68502018-002608-15
• Study Type: interventional
• Target: 289
• Locations: 7 countries
• Sites: 52

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 (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.

Conditions

Psoriasis

Keywords

Genital Psoriasis; CC-10004; Apremilast; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Modified sPGA-G Response at Week 16

  The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling. A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.

  Baseline and Week 16 of the Placebo-controlled Phase

Secondary Outcomes (5)

• Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Change From Baseline in Affected Body Surface Area (BSA) at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

  Baseline and Week 16 of the placebo-controlled phase

Study Arms (2)

Arm A- Apremilast with Placebo

EXPERIMENTAL

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

Drug: Apremilast; Other: Placebo

Arm B - Apremilast 30 mg

EXPERIMENTAL

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

Drug: Apremilast

Interventions

Apremilast DRUG

Oral

Also known as: CC-10004, Otezla

Arm A- Apremilast with Placebo; Arm B - Apremilast 30 mg

Placebo OTHER

Oral

Arm A- Apremilast with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Glick Skin Institute

Margate, Florida, 33073, United States

Location

International Dermatology Research, Inc

Miami, Florida, 33144, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Adult and Pediatric Dermatology

Overland Park, Kansas, 66211, United States

Location

ActivMed Practices and Research Inc

Beverly, Massachusetts, 01915, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

J Woodson Dermatology and Associates

Henderson, Nevada, 89052, United States

Location

Las Vegas Dermatology

Las Vegas, Nevada, 89144, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

ActivMed

Portsmouth, New Hampshire, 03801, United States

Location

Stony Brook Dermatology Associates

Stony Brook, New York, 11790, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Oakview Dermatology

Athens, Ohio, 45701, United States

Location

Ohio State University Medical Center

Gahanna, Ohio, 43230, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Paddington Testing Company Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Partners LLC

Johnston, Rhode Island, 02919, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Virginia Clinical Research Inc

Norfolk, Virginia, 23502, United States

Location

Bellevue Dermatology Clinic

Bellevue, Washington, 98004, United States

Location

Dermatology Center for Skin Health

Morgantown, West Virginia, 26505, United States

Location

Centre Hospitalier Universitaire Saint Pierre

Brussels, 1000, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P1X2, Canada

Location

K Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Dre Angelique Gagne-Henley M.D. Inc

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Skincare Studio

St. John's, A1E 1V4, Canada

Location

Hopital Claude Huriez CHRU Lille

Lille, 59037, France

Location

CHU de Nice Archet I

Nice, 06202, France

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre

Pessac, 33604, France

Location

Larrey University Hospital

Toulouse, 31000, France

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitaetsklinikum Bonn

Bonn, 53127, Germany

Location

Hautklinik Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

Lübeck, 23538, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

Location

Ospedali Riuniti di Ancona

Ancona, 60020, Italy

Location

Presidio Ospedaliero della Misericordia

Grosseto, 58100, Italy

Location

Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore

LAquila, 67100, Italy

Location

Azienda Ospedaliera Di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, 89124, Italy

Location

Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina

Terracina, 04019, Italy

Location

Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, 34125, Italy

Location

GCM Medical Group, PSC

San Juan, 00917, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 37852306 BACKGROUND

• Merola JF, Guenther L, Lynde C, Papp KA, Parish LC, Yamauchi P, Cheng S, Amouzadeh H, Deignan C, Jardon S, Chen M, Pinter A. Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis. J Eur Acad Dermatol Venereol. 2025 Dec 10. doi: 10.1111/jdv.70110. Online ahead of print.

  PMID: 41369155 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: February 11, 2019
• Primary Completion: September 23, 2021
• Study Completion: February 9, 2022
• Last Updated: May 14, 2024
• Results First Posted: December 15, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (26); CA (5); IT (7); DE (6); BE (3); FR (4); PR (1)