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

Psoriasis Clinical Trial

— DISCREET  

Official title:

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777436
• Other study ID #: CC-10004-PSOR-025
• Secondary ID: U1111-1224-68502
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2019
• Est. completion date: February 9, 2022

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: February 9, 2022
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Apremilast
Oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire Saint Pierre	Brussels
Belgium	Cliniques Universitaires St Luc	Bruxelles
Belgium	UZ Leuven	Leuven
Canada	Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Dre Angelique Gagne-Henley M.D. Inc	Saint-Jerome	Quebec
Canada	Skincare Studio	St. John's
Canada	K Papp Clinical Research	Waterloo	Ontario
France	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
Germany	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	Luebeck
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Italy	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	Padova
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
Puerto Rico	GCM Medical Group, PSC	San Juan
United States	Oakview Dermatology	Athens	Ohio
United States	Bellevue Dermatology Clinic	Bellevue	Washington
United States	ActivMed Practices and Research Inc	Beverly	Massachusetts
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	First OC Dermatology	Fountain Valley	California
United States	Ohio State University Medical Center	Gahanna	Ohio
United States	J Woodson Dermatology and Associates	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners LLC	Johnston	Rhode Island
United States	Las Vegas Dermatology	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Skin Care Physicians of Georgia	Macon	Georgia
United States	Glick Skin Institute	Margate	Florida
United States	International Dermatology Research, Inc	Miami	Florida
United States	Dermatology Center for Skin Health	Morgantown	West Virginia
United States	Virginia Clinical Research Inc	Norfolk	Virginia
United States	Adult and Pediatric Dermatology	Overland Park	Kansas
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	ActivMed	Portsmouth	New Hampshire
United States	Clinical Science Institute	Santa Monica	California
United States	Stony Brook Dermatology Associates	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Puerto Rico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16	The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.; An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with = 2-point reduction from Baseline at Week 16.; Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.	Baseline and Week 16 of the placebo-controlled phase
Secondary	Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16	The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.; A GPI-NRS response is defined as = 4 point reduction (improvement) from Baseline.; Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.	Baseline and Week 16 of the placebo-controlled phase
Secondary	Change From Baseline in Affected Body Surface Area (BSA) at Week 16	The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total BSA).; A negative change from Baseline indicates a reduction of affected BSA.; Based on mixed-effect model for repeated measures (MMRM) model.	Baseline and Week 16 of the placebo-controlled phase
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).; Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.; A negative change from Baseline indicates an improvement in health-related quality of life scores.	Baseline and Week 16 of the placebo-controlled phase
Secondary	Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16	The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.; Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).; A negative change from Baseline indicates an improvement in genital psoriasis symptoms.	Baseline and Week 16 of the placebo-controlled phase

External Links

•   AmgenTrials clinical trials website