Clincosm LogoSign in Get a demo

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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT03777436
Collaborator
(none)
289
Enrollment
52
Locations
2
Arms
35.9
Actual Duration (Months)
5.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
289 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
Actual Study Start Date :
Feb 11, 2019
Actual Primary Completion Date :
Sep 23, 2021
Actual Study Completion Date :
Feb 9, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • CC-10004, Otezla

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects with a modified sPGA-G score of [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 [Up to week 16]

      Static PGA (sPGA)

    2. Proportion of subjects with at least a 4-point improvement in [Up to week 16]

      Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS)

    3. Change from baseline in affected BSA at Week 16 [Up to week 16]

      Body Surface Area (BSA)

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

      Genital psoriasis symptoms scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 First OC Dermatology Fountain Valley California United States 92708
    3 Clinical Science Institute Santa Monica California United States 90404
    4 Glick Skin Institute Margate Florida United States 33073
    5 International Dermatology Research, Inc Miami Florida United States 33144
    6 Skin Care Physicians of Georgia Macon Georgia United States 31217
    7 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
    8 Adult and Pediatric Dermatology Overland Park Kansas United States 66211
    9 ActivMed Practices and Research Inc Beverly Massachusetts United States 01915
    10 Brigham and Womens Hospital Boston Massachusetts United States 02115
    11 J Woodson Dermatology and Associates Henderson Nevada United States 89052
    12 Las Vegas Dermatology Las Vegas Nevada United States 89144
    13 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03766
    14 ActivMed Portsmouth New Hampshire United States 03801
    15 Stony Brook Dermatology Associates Stony Brook New York United States 11790
    16 Dermatology Consulting Services High Point North Carolina United States 27262
    17 Oakview Dermatology Athens Ohio United States 45701
    18 Ohio State University Medical Center Gahanna Ohio United States 43230
    19 Oregon Health and Science University Portland Oregon United States 97239
    20 Paddington Testing Company Inc Philadelphia Pennsylvania United States 19103
    21 Clinical Partners LLC Johnston Rhode Island United States 02919
    22 Center for Clinical Studies Houston Texas United States 77004
    23 Austin Institute for Clinical Research Pflugerville Texas United States 78660
    24 Virginia Clinical Research Inc Norfolk Virginia United States 23502
    25 Bellevue Dermatology Clinic Bellevue Washington United States 98004
    26 Dermatology Center for Skin Health Morgantown West Virginia United States 26505
    27 Centre Hospitalier Universitaire Saint Pierre Brussels Belgium 1000
    28 Cliniques Universitaires St Luc Bruxelles Belgium 1200
    29 UZ Leuven Leuven Belgium 3000
    30 Guenther Dermatology Research Centre London Ontario Canada N6A 3H7
    31 Lynderm Research Inc Markham Ontario Canada L3P1X2
    32 K Papp Clinical Research Waterloo Ontario Canada N2J 1C4
    33 Dre Angelique Gagne-Henley M.D. Inc Saint-Jerome Quebec Canada J7Z 7E2
    34 Skincare Studio St. John's Canada A1E 1V4
    35 Hopital Claude Huriez CHRU Lille Lille France 59037
    36 CHU de Nice Archet I Nice France 06202
    37 Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre Pessac France 33604
    38 Larrey University Hospital Toulouse France 31000
    39 ISA - Interdisciplinary Study Association GmbH Berlin Germany 10789
    40 Universitaetsklinikum Bonn Bonn Germany 53127
    41 Hautklinik Universitatsklinikum Erlangen Erlangen Germany 91054
    42 Universitatsklinikum Frankfurt Frankfurt am Main Germany 60590
    43 Universitaetsklinikum Schleswig-Holstein, Campus Luebeck Luebeck Germany 23538
    44 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55101
    45 Ospedali Riuniti di Ancona Ancona Italy 60020
    46 Presidio Ospedaliero della Misericordia Grosseto Italy 58100
    47 Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore LAquila Italy 67100
    48 Azienda Ospedaliera Di Padova Padova Italy 35128
    49 Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Calabria Italy 89124
    50 Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina Terracina Italy 04019
    51 Azienda Sanitaria Universitaria Integrata di Trieste Trieste Italy 34125
    52 GCM Medical Group, PSC San Juan Puerto Rico 00917

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03777436
    Other Study ID Numbers:
    • CC-10004-PSOR-025
    • U1111-1224-6850
    • 2018-002608-15
    First Posted:
    Dec 17, 2018
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Genital Psoriasis
    CC-10004
    Apremilast
    Plaque Psoriasis
    Additional relevant MeSH terms:
    Psoriasis
    Apremilast

    Study Results

    No Results Posted as of Feb 21, 2022