Status:
RECRUITING
Taltz in Combination With Enstilar for Psoriasis
Lead Sponsor:
Psoriasis Treatment Center of Central New Jersey
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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%.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04372277
Start Date
April 28 2020
End Date
March 30 2021
Last Update
May 4 2020
Active Locations (1)
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1
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520