Psoriasis Clinical Trial

Taltz in Combination With Enstilar for Psoriasis

Summary

Enstilar in combination with Taltz for plaque psoriasis.

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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%.

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Eligibility 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.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

25

Study ID:

NCT04372277

Recruitment Status:

Unknown status

Sponsor:

Psoriasis Treatment Center of Central New Jersey

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There is 1 Location for this study

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Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States More Info
Elise Nelson
Contact
609-443-4500
[email protected]
Jerry Bagel, MD
Principal Investigator
David Nieves, MD
Sub-Investigator
Wendy Myers, MD
Sub-Investigator
Alexa Hetzel, PA-C
Sub-Investigator
Brianna Butler, PA-C
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

25

Study ID:

NCT04372277

Recruitment Status:

Unknown status

Sponsor:


Psoriasis Treatment Center of Central New Jersey

How clear is this clinincal trial information?

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