Psoriasis
Conditions
Brief summary
Enstilar in combination with Taltz for plaque psoriasis.
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
DRUGEnstilar
topical Enstilar foam
Sponsors
Eli Lilly and Company
Psoriasis Treatment Center of Central New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Surface Area 0 or 1 | 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. |
Countries
United States
Contacts
Primary ContactJerry Bagel, MD
Backup ContactElise Nelson
Outcome results
None listed