Phase 3
Completed N=289
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Source: ClinicalTrials.gov NCT03777436 ↗Enrolled (actual)
289
Serious AEs
1.4%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants With a Modified sPGA-G Response at Week 16 — 19.5; 39.6 Percentage of participants — p=0.0003
◆ Published Evidence
Established
27citations · ~14 / year
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.
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.
Linked Publications (2)
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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.
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Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Modified sPGA-G Response at Week 16 |
19.5; 39.6 | 0.0003 sig |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 |
6.9; 22.2 | 0.0004 sig |
| SECONDARY Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16 |
19.6; 47.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Affected Body Surface Area (BSA) at Week 16 |
-0.79; -4.12 | 0.0005 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-2.6; -5.3 | 0.0008 sig |
| SECONDARY Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16 |
-5.3; -20.5 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03777436) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.