Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments 122-0551 foam, vehicle foam
Phase phase 3
Sponsor Therapeutics, Inc.
Start date January 2015
End date September 2015
Trial size 140 participants
Trial identifier NCT02368210, 122-0551-306

Summary

This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
122-0511 Foam, topically applied twice daily
122-0551 foam
Topical Foam
(Placebo Comparator)
Vehicle Foam, topically applied twice daily
vehicle foam
Topical Foam

Primary Outcomes

Measure
Proportion of subjects rated a "treatment success" based on the Investigator's Global Assessment (IGA)
time frame: Day 15

Secondary Outcomes

Measure
Proportion of subjects rated a "treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
time frame: Day 15

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area. - Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start. - If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study. Exclusion Criteria: - Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. - Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. - Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation. - Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start. - Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to study start. - Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start. - Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.

Additional Information

Official title A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Therapeutics, Inc..