Skip to main content
OpenTrials
Completed

NCT Number: NCT03777436

An Efficacy and Safety Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire Saint Pierre, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion 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.

Treatment and study plan

Apremilast

Drug

Oral

Other names: CC-10004, Otezla

Placebo

Other

Oral

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Acronym: DISCREET

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 17, 2018
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.