Taltz in Combination With Enstilar for Psoriasis

NCT04372277 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PTC06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Enstilar in combination with Taltz for plaque psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Enstilar

EXPERIMENTAL

Enstilar foam

Drug: Enstilar

Interventions

Enstilar DRUG

topical Enstilar foam

Enstilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ˂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.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jerry Bagel, MD

CONTACT

6094434500; dreamacres1@aol.com

Elise Nelson

CONTACT

6094434500; enelson@windsordermatology.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: April 28, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 30, 2021
• Last Updated: May 4, 2020

Record last verified: 2020-04

Locations

US (1)