Taltz in Combination With Enstilar for Psoriasis

• Status: Recruiting
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Enstilar in combination with Taltz for plaque psoriasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborator: Eli Lilly and Company
• Treatments: Calcipotriene

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.