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

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ClinicalTrials.gov Identifier: NCT03777436
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 19, 2019
Estimated Primary Completion Date : August 24, 2020
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Arm A- Apremilast with 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
Drug: Apremilast
Oral
Other Name: CC-10004, Otezla

Other: Placebo
Oral

Experimental: Arm B - Apremilast 30 mg
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
Drug: Apremilast
Oral
Other Name: CC-10004, Otezla




Primary Outcome Measures :
  1. Proportion of subjects with a modified sPGA-G score of [ Time Frame: up to week 16 ]
    Modified Static Physician Global Assessment of Genitalia (modified sPGA-G)


Secondary Outcome Measures :
  1. Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 [ Time Frame: Up to week 16 ]
    Static PGA (sPGA)

  2. Proportion of subjects with at least a 4-point improvement in [ Time Frame: Up to week 16 ]
    Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS)

  3. Change from baseline in affected BSA at Week 16 [ Time Frame: Up to week 16 ]
    Body Surface Area (BSA)

  4. Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Up to week 16 ]
    Dermatology Life Quality Index

  5. Change from baseline in Genital Psoriasis Symptoms Scale (GPSS)total score and individual item scores at Week 16 [ Time Frame: Up to week 16 ]
    Genital psoriasis symptoms scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
  3. Subject must have a diagnosis of moderate or severe psoriasis of the genital area at Screening and Baseline.
  4. Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline.
  5. Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline.
  6. 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.
  7. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
  8. Subject must meet laboratory criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
  2. 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.
  3. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
  4. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
  5. 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.
  6. 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
  7. Subject had prior treatment with apremilast.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777436


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
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Study Director: Yao Wang, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03777436     History of Changes
Other Study ID Numbers: CC-10004-PSOR-025
U1111-1224-6850 ( Registry Identifier: WHO )
2018-002608-15 ( EudraCT Number )
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Genital Psoriasis
CC-10004
Apremilast

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents