Clinical trial NCT03777436: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Genital Psoriasis
CC-10004
Apremilast
Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-12-17
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With a Modified sPGA-G Response at Week 16
timeFrame: Baseline and Week 16 of the Placebo-controlled Phase
Secondary outcomes:
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
timeFrame: Baseline and Week 16 of the placebo-controlled phase
measure: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16
timeFrame: Baseline and Week 16 of the placebo-controlled phase
measure: Change From Baseline in Affected Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16 of the placebo-controlled phase
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline and Week 16 of the placebo-controlled phase
measure: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
timeFrame: Baseline and Week 16 of the placebo-controlled phase
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Margate
country: United States
facility: Glick Skin Institute
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Overland Park
country: United States
facility: Adult and Pediatric Dermatology
state: Kansas
city: Beverly
country: United States
facility: ActivMed Practices and Research Inc
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Henderson
country: United States
facility: J Woodson Dermatology and Associates
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Dermatology
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Portsmouth
country: United States
facility: ActivMed
state: New Hampshire
city: Stony Brook
country: United States
facility: Stony Brook Dermatology Associates
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Athens
country: United States
facility: Oakview Dermatology
state: Ohio
city: Gahanna
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc
state: Virginia
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinic
state: Washington
city: Morgantown
country: United States
facility: Dermatology Center for Skin Health
state: West Virginia
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint Pierre
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: London
country: Canada
facility: Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Waterloo
country: Canada
facility: K Papp Clinical Research
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. Inc
state: Quebec
city: St. John's
country: Canada
facility: Skincare Studio
city: Lille
country: France
facility: Hopital Claude Huriez CHRU Lille
city: Nice
country: France
facility: CHU de Nice Archet I
city: Pessac
country: France
facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
city: Toulouse
country: France
facility: Larrey University Hospital
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Erlangen
country: Germany
facility: Hautklinik Universitatsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Grosseto
country: Italy
facility: Presidio Ospedaliero della Misericordia
city: LAquila
country: Italy
facility: Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi Melacrino Morelli
city: Terracina
country: Italy
facility: Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.