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NCT04372277PHASE4Recruiting

Taltz in Combination With Enstilar for Psoriasis

Psoriasis Treatment Center of Central New Jersey

Start Date

4/28/2020

Completion Date

3/30/2021

Summary

Enstilar in combination with Taltz for plaque psoriasis.

Detailed Description

A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Male or female adult ≥ 18 years of age; * Diagnosis of chronic plaque-type * Body Surface Area between 3%-8%. * Patient has been treated with Taltz for a minimum of 24 weeks * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. * Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination * Able and willing to give written informed consent prior to performance of any study-related procedures. Exclusion Criteria -˂3% or \>8% BSA * Patient not receiving Taltz, or receiving Taltz \<24 weeks * Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. * Pregnant or breast feeding, or considering becoming pregnant during the study. * Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). * Use of oral systemic medications for the treatment of psoriasis within 4 weeks. * Patient used other topical therapies to treat within 2 weeks of the Baseline Visit. * Patient received UVB phototherapy within 2 weeks of Baseline. * Patient received PUVA phototherapy within 4 weeks of Baseline. * Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Interventions

DRUG

Enstilar

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Conditions

Psoriasis

Locations

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey 08520

United States