Taltz in Combination With Enstilar for Psoriasis

Last updated: April 29, 2020
Sponsor: Psoriasis Treatment Center of Central New Jersey
Overall Status: Active - Recruiting

Phase

4

Condition

Rosacea

Warts

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT04372277
PTC06
  • Ages > 18
  • All Genders

Study Summary

Enstilar in combination with Taltz for plaque psoriasis.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 25
Study Start date:
April 28, 2020
Estimated Completion Date:
March 30, 2021

Study 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%.

Connect with a study center

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

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