A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: 122-0551 Foam; Drug: Vehicle Foam

• Registration Number: NCT02368210
• Lead Sponsor: Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-23
• Primary Completion: 2015-06
• Study Completion: 2017-02
• Disposition First Submitted: 2017-02-16
• Disposition First Submitted QC: 2017-02-16
• Disposition First Posted: 2017-02-17
• Results First Submitted: 2018-08-30
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-24
• Last Update Submitted: 2018-10-24
• Results First Posted: 2018-11-26
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
122-0551 Foam	122-0551 Foam	122-0511 Foam, topically applied twice daily
Vehicle Foam	Vehicle Foam	Vehicle Foam, topically applied twice daily

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	Day 15	The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)	Day 15	A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).

Trial Locations

Locations (8)

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Dermatology Associates of Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Center for Dermatology Clinical Research; 🇺🇸 Fremont, California, United States

The Center for Skin Research; 🇺🇸 Houston, Texas, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Altman Dermatology Associates; 🇺🇸 Arlington Heights, Illinois, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States