Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Study Purpose

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque 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 must be male or female, ≥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 mild to moderate plaque psoriasis at both Screening and Baseline. 4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline. 5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 6. Subject must meet laboratory criteria. 7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening. 6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial. 8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 9. 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.	NCT03721172
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.	Celgene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yao Wang, MD
Principal Investigator Affiliation	Celgene Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis

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: Apremilast 30 mg or Placebo

Oral Apremilast 30 mg or placebo twice daily (BID) from Week 0 to Week 16

Experimental: Apremilast 30 mg, extension

Apremilast 30 mg twice daily (BID) from Week 16 to Week 32

Interventions

Drug: - Apremilast

Apremilast, oral, twice daily

Other: - Placebo

Placebo, oral, twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Total Skin & Beauty Dermatology Center, Birmingham, Alabama

Status

Recruiting

Address

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205

Site Contact

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