RecruitingPhase 4NCT04372277

Taltz in Combination With Enstilar for Psoriasis

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


Sponsor

Psoriasis Treatment Center of Central New Jersey

Enrollment

25 participants

Start Date

Apr 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Enstilar in combination with Taltz for plaque psoriasis.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria10

  • ˂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.

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Interventions

DRUGEnstilar

topical Enstilar foam


Locations(1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

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NCT04372277


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