An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
- Registration Number
- NCT03777436
- Lead Sponsor
- Amgen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 289
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A- Apremilast with Placebo 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 Arm B - Apremilast 30 mg Apremilast 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 Arm A- Apremilast with Placebo Apremilast 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
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Modified sPGA-G Response at Week 16 Baseline and Week 16 of the Placebo-controlled Phase 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 Baseline and Week 16 of the placebo-controlled phase 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.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 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.Change From Baseline in Affected Body Surface Area (BSA) at Week 16 Baseline and Week 16 of the placebo-controlled phase 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.Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16 Baseline and Week 16 of the placebo-controlled phase 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.Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Baseline and Week 16 of the placebo-controlled phase 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.
Trial Locations
- Locations (52)
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Oakview Dermatology
🇺🇸Athens, Ohio, United States
Ohio State University Medical Center
🇺🇸Gahanna, Ohio, United States
Cliniques Universitaires St Luc
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
International Dermatology Research, Inc
🇺🇸Miami, Florida, United States
Centre Hospitalier Universitaire Saint Pierre
🇧🇪Brussels, Belgium
Bellevue Dermatology Clinic
🇺🇸Bellevue, Washington, United States
Paddington Testing Company Inc
🇺🇸Philadelphia, Pennsylvania, United States
Dre Angelique Gagne-Henley M.D. Inc
🇨🇦Saint-Jerome, Quebec, Canada
Universitatsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Hautklinik Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
Hopital Claude Huriez CHRU Lille
🇫🇷Lille, France
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Presidio Ospedaliero della Misericordia
🇮🇹Grosseto, Italy
CHU de Nice Archet I
🇫🇷Nice, France
Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore
🇮🇹LAquila, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
K Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Azienda Sanitaria Universitaria Integrata di Trieste
🇮🇹Trieste, Italy
Azienda Ospedaliera Di Padova
🇮🇹Padova, Italy
Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina
🇮🇹Terracina, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Las Vegas Dermatology
🇺🇸Las Vegas, Nevada, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Guenther Dermatology Research Centre
🇨🇦London, Ontario, Canada
First OC Dermatology
🇺🇸Fountain Valley, California, United States
ActivMed Practices and Research Inc
🇺🇸Beverly, Massachusetts, United States
Glick Skin Institute
🇺🇸Margate, Florida, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
J Woodson Dermatology and Associates
🇺🇸Henderson, Nevada, United States
Adult and Pediatric Dermatology
🇺🇸Overland Park, Kansas, 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
Clinical Partners LLC
🇺🇸Johnston, Rhode Island, United States
Virginia Clinical Research Inc
🇺🇸Norfolk, Virginia, United States
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Dermatology Center for Skin Health
🇺🇸Morgantown, West Virginia, United States
Skincare Studio
🇨🇦St. John's, Canada
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
🇩🇪Luebeck, Germany
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
🇫🇷Pessac, France
Larrey University Hospital
🇫🇷Toulouse, France
GCM Medical Group, PSC
🇵🇷San Juan, Puerto Rico