Taltz in Combination With Enstilar for Psoriasis

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Enstilar

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Recruiting
      • Psoriasis Treatment Center of Central New Jersey
      • Contact: Elise Nelson; Phone Number: 609-443-4500; Email: enelson@windsordermatology.com
      • Sub-Investigator: Wendy Myers, MD
      • Sub-Investigator: Brianna Butler, PA-C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enstilar; Enstilar foam	Drug: Enstilar; topical Enstilar foam

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PTC06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes