Taltz in Combination With Enstilar for Psoriasis

Psoriasis Treatment Center of Central New Jersey

Status and phase

Enrolling

Phase 4

Conditions

Psoriasis

Treatments

Drug: Enstilar

Study type

Interventional

Funder types

Other

Industry

Identifiers

PTC06

Details and patient eligibility

About

Enstilar in combination with Taltz for plaque psoriasis.

Full 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%.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.