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

Plaque Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368210
• Other study ID #: 122-0551-306
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: February 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 122-0551 Foam
Topical Foam
• Vehicle Foam
Topical Foam

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	The Center for Skin Research	Houston	Texas
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Subjects With IGA "Treatment Success"	"Treatment success" and IGA as defined in the primary outcome measure. "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).	Day 8
Other	Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)	"Treatment success" and clinical signs as defined in the secondary outcome measure. "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).	Day 8
Other	Change From Baseline in Pruritus Score	Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).	Baseline and Day 15
Other	Change in Percent Body Surface Area (BSA) With Active Psoriasis	The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.	Baseline and Day 15
Primary	Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	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).	Day 15
Secondary	Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)	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).	Day 15