Recruiting NCT04372277

Taltz in Combination With Enstilar for Psoriasis

Phase IV Interventional Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Enstilar.
Who it may be relevant to: Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients

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%.

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.

-˂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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT04372277 · PTC06