Taltz in Combination With Enstilar for Psoriasis

Overview

Enstilar in combination with Taltz for plaque psoriasis.

Full Title of Study: “Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2021

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%.

Interventions

  • Drug: Enstilar
    • topical Enstilar foam

Arms, Groups and Cohorts

  • Experimental: Enstilar
    • Enstilar foam

Clinical Trial Outcome Measures

Primary Measures

  • Body Surface Area 0 or 1
    • Time Frame: 4 weeks
    • Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Psoriasis Treatment Center of Central New Jersey
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jerry Bagel, MD, 6094434500, dreamacres1@aol.com

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