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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03777436
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, France, Germany, Italy, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

Drug: - Apremilast

Oral

Other: - Placebo

Oral

Contact a Trial Team

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Research Site, Birmingham, Alabama

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Recruiting

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Birmingham, Alabama, 35233

Research Site, Fountain Valley, California

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Fountain Valley, California, 92708

Research Site, Santa Monica, California

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Santa Monica, California, 90404

Research Site, Hollywood, Florida

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Hollywood, Florida, 33021

Research Site, Margate, Florida

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Margate, Florida, 33073

Research Site, Macon, Georgia

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Macon, Georgia, 31217

Research Site, Indianapolis, Indiana

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Indianapolis, Indiana, 46256

Research Site, Overland Park, Kansas

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Overland Park, Kansas, 66211

Research Site, Beverly, Massachusetts

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Beverly, Massachusetts, 01915

Research Site, Boston, Massachusetts

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Boston, Massachusetts, 02115

Research Site, Henderson, Nevada

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Henderson, Nevada, 89052

Research Site, Las Vegas, Nevada

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Las Vegas, Nevada, 89144

Research Site, Lebanon, New Hampshire

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Lebanon, New Hampshire, 03756

Research Site, Portsmouth, New Hampshire

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Portsmouth, New Hampshire, 03801

Research Site, New Hyde Park, New York

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New Hyde Park, New York, 11040

Research Site, High Point, North Carolina

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High Point, North Carolina, 27262

Research Site, Athens, Ohio

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Athens, Ohio, 45701

Research Site, Gahanna, Ohio

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Gahanna, Ohio, 43230

Research Site, Portland, Oregon

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Portland, Oregon, 97239

Research Site, Philadelphia, Pennsylvania

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Philadelphia, Pennsylvania, 19103

Research Site, Johnston, Rhode Island

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Johnston, Rhode Island, 02919

Research Site, Austin, Texas

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Austin, Texas, 78732

Research Site, Houston, Texas

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Houston, Texas, 77004

Research Site, Norfolk, Virginia

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Norfolk, Virginia, 23502

Research Site, Seattle, Washington

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Seattle, Washington, 98101

Research Site, Morgantown, West Virginia

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Morgantown, West Virginia, 26505

International Sites

Research Site, Graz, Austria

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Recruiting

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Graz, , 8036

Research Site, Brussels, Belgium

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Recruiting

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Brussels, , 1000

Research Site, Brussels, Belgium

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Brussels, , 1200

Research Site, Leuven, Belgium

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Leuven, , 3000

Research Site, St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, A1E 1V4

Research Site, London, Ontario, Canada

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London, Ontario, N6A 3H7

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Markham, Ontario, L3P 1X3

Research Site, Waterloo, Ontario, Canada

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Waterloo, Ontario, N2J 1C4

Research Site, Saint-Jerome, Quebec, Canada

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Saint-Jerome, Quebec, J7Z 7E2

Research Site, Bordeaux, France

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Bordeaux, , 33075

Research Site, Lille cedex, France

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Lille cedex, , 59037

Research Site, Nice, France

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Nice, , 06200

Research Site, Toulouse Cedex 9, France

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Toulouse Cedex 9, , 31059

Research Site, Berlin, Germany

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Berlin, , 10789

Research Site, Bonn, Germany

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Bonn, , 53105

Research Site, Erlangen, Germany

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Erlangen, , 91054

Research Site, Frankfurt am Main, Germany

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Frankfurt am Main, , 60590

Research Site, Lübeck, Germany

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Lübeck, , 23538

Research Site, Mainz, Germany

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Mainz, , 55101

Research Site, Ancona, Italy

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Recruiting

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Ancona, , 60126

Research Site, Grosseto, Italy

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Recruiting

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Grosseto, , 58100

Research Site, L'Aquila, Italy

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Recruiting

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L'Aquila, , 67100

Research Site, Reggio Calabria, Italy

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Recruiting

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Research Site

Reggio Calabria, , 89100

Research Site, Terracina, Italy

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Recruiting

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Research Site

Terracina, , 04019

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