Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

Study Purpose

Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.

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 be in general good health as judged by investigator - Female of childbearing potential (FCBP) must have a negative pregnancy test at screening and Baseline.
  • - FCBP must use an approved method of contraception as outlined in the protocol.
  • - Male subjects who engage in activity in which conception is possible must use barrier contraception as defined in the protocol.
  • - 18 years of age or older - Understand and voluntarily sign the Informed Consent - Able to adhere to study visit schedule - Moderate plaque type psoriasis as define by a a PGA of 3 - BSA 0f 5-10% or a DLQI score of 7 or more - History of uncontrolled plaque psoriasis after either stable dose of high potency topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6 months

    Exclusion Criteria:

    - Any clinically significant disease as determined by the investigator or major disease that is currently uncontrolled - Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk - Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years - Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control methods.
  • - Active substance abuse or a history of substance abuse within 6 months prior to screening.
- Malignancy or history of malignancy except fo treated (cured) basal cell or or squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years - Has not completed the prescribed washout for restricted treatments - Known or suspected allergy to investigational product - Other types of psoriasis - Prior history of depression - Prior use of 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.

NCT03000309
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 4
Lead Sponsor

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

Derm Research, PLLC
Principal Investigator

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

Leon H. Kircik, M.D.
Principal Investigator Affiliation DermResearch PLLC
Agency Class

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

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

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

Plaque Psoriasis
Additional Details

This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)

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.

DermResearch, PLLC, Louisville, Kentucky

Status

Recruiting

Address

DermResearch, PLLC

Louisville, Kentucky, 40217

Site Contact

Leon H. Kircik, M.D.

wedoderm@yahoo.com

502-451-9000

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