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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    332
  • sponsor
    Amgen
Updated on 23 December 2020
Investigator
Amgen Call Center
Primary Contact
Hautklinik Universitatsklinikum Erlangen (8.7 mi away) Contact
+119 other location
topical agents
cc-10004
apremilast
plaque psoriasis

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 332 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.

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.

Details
Treatment Placebo, Apremilast
Clinical Study IdentifierNCT03777436
SponsorAmgen
Last Modified on23 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Psoriasis and Psoriatic Disorders or Psoriasis?
Do you have any of these conditions: Psoriasis or Psoriasis and Psoriatic Disorders?
Do you have any of these conditions: Psoriasis or Psoriasis and Psoriatic Disorders?
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
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