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
Conditions
Psoriasis
Locations
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520
United States