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PsoriasisPhase 3DISCREETNCT03777436

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

A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 52 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
289 participants
Where
52 sitesin 7 countries
Study dates
11 Feb 2019to 9 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 7 countries.

52 sites in 7 countries

United States26 sites

  • Oakview Dermatology

    Athens, Ohio, 45701

  • Bellevue Dermatology Clinic

    Bellevue, Washington, 98004

  • ActivMed Practices and Research Inc

    Beverly, Massachusetts, 01915

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Ohio State University Medical Center

    Gahanna, Ohio, 43230

  • J Woodson Dermatology and Associates

    Henderson, Nevada, 89052

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Las Vegas Dermatology

    Las Vegas, Nevada, 89144

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • Glick Skin Institute

    Margate, Florida, 33073

  • International Dermatology Research, Inc

    Miami, Florida, 33144

  • Dermatology Center for Skin Health

    Morgantown, West Virginia, 26505

  • Virginia Clinical Research Inc

    Norfolk, Virginia, 23502

  • Adult and Pediatric Dermatology

    Overland Park, Kansas, 66211

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • Paddington Testing Company Inc

    Philadelphia, Pennsylvania, 19103

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • ActivMed

    Portsmouth, New Hampshire, 03801

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Stony Brook Dermatology Associates

    Stony Brook, New York, 11790

Other trials in United States

Italy7 sites

  • Ospedali Riuniti di Ancona

    Ancona, 60020

  • Presidio Ospedaliero della Misericordia

    Grosseto, 58100

  • Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore

    LAquila, 67100

  • Azienda Ospedaliera Di Padova

    Padova, 35128

  • Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria, 89124

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

    Terracina, 04019

  • Azienda Sanitaria Universitaria Integrata di Trieste

    Trieste, 34125

Other trials in Italy

Germany6 sites

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789

  • Universitaetsklinikum Bonn

    Bonn, 53127

  • Hautklinik Universitatsklinikum Erlangen

    Erlangen, 91054

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

    Lübeck, 23538

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55101

Other trials in Germany

Canada5 sites

  • Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7

  • Lynderm Research Inc

    Markham, Ontario, L3P1X2

  • Dre Angelique Gagne-Henley M.D. Inc

    Saint-Jérôme, Quebec, J7Z 7E2

  • Skincare Studio

    St. John's, A1E 1V4

  • K Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

France4 sites

  • Hopital Claude Huriez CHRU Lille

    Lille, 59037

  • CHU de Nice Archet I

    Nice, 06202

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

    Pessac, 33604

  • Larrey University Hospital

    Toulouse, 31000

Other trials in France

Belgium3 sites

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, 1000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Puerto Rico1 site

  • GCM Medical Group, PSC

    San Juan, 00917

Other trials in Puerto Rico

About this study

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

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.

Read the 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.
Conditions
Psoriasis
Being tested
Apremilast, Placebo
Keywords
Genital Psoriasis, CC-10004, Apremilast, Plaque Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called CC-10004, Otezla

    Oral

  • PlaceboOther

    Oral

Study groups in NCT03777436
Study groupRoleWhat they receive
Arm A- Apremilast with PlaceboExperimentalSubjects 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
Receives: Drug: Apremilast; Other: Placebo
Arm B - Apremilast 30 mgExperimentalAll 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
Receives: Drug: Apremilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 16 of the Placebo-controlled Phase

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and Week 16 of the placebo-controlled phase

  2. 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.

    Measured: Baseline and Week 16 of the placebo-controlled phase

  3. 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.

    Measured: Baseline and Week 16 of the placebo-controlled phase

  4. 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.

    Measured: Baseline and Week 16 of the placebo-controlled phase

  5. 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.

    Measured: Baseline and Week 16 of the placebo-controlled phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start11 Feb 2019
  3. Primary completion23 Sep 2021
  4. Study completion9 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777436
Sponsor's protocol ID
CC-10004-PSOR-025
Other IDs
U1111-1224-6850, 2018-002608-15, 2018
Acronym
DISCREET
Status last verified
May 2024
First submitted
14 Dec 2018
Last updated
14 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Expanded access
Available

Publications

  • 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.

    PubMed 37852306

  • Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.

    PubMed 42825996

  • 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. 2026 Feb;40(2):274-284. doi: 10.1111/jdv.70110. Epub 2025 Dec 10.

    PubMed 41369155

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 52 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Italy, Germany, Canada, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Modified sPGA-G Response at Week 16 (time frame: Baseline and Week 16 of the Placebo-controlled Phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03777436, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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