Tests Taltz with Enstilar foam for skin psoriasis
Tests Taltz combined with Enstilar foam in adults with psoriasis.
Plain-language title generated from the registry record
Registry title: Taltz in Combination With Enstilar for Psoriasis
Key facts
- Where
- East Windsor, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Psoriasis Treatment Center of Central New JerseyEast Windsor, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Psoriasis Treatment Center of Central New Jersey
- Trial code
- NCT04372277
- Record updated
- 4 May 2020
- Original description
Enstilar in combination with Taltz for plaque psoriasis.Read full original descriptionShow less
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.
Inclusion: 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: Patient not receiving Taltz, or receiving Taltz <24 weeks; 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; Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study; Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label; -˂3% or >8% BSA; Pregnant or breast feeding, or considering becoming pregnant during the study.