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

NCT02368210 | Completed Phase 3 Results

• 1 other identifier: 122-0551-306
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 8

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)

  Day 15

Other Outcomes (4)

• Percentage of Subjects With IGA "Treatment Success"

  Day 8

• Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)

  Day 8

• Change From Baseline in Pruritus Score

  Baseline and Day 15

Study Arms (2)

122-0551 Foam

EXPERIMENTAL

122-0511 Foam, topically applied twice daily

Drug: 122-0551 Foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Foam, topically applied twice daily

Drug: Vehicle Foam

Interventions

122-0551 Foam DRUG

Topical Foam

122-0551 Foam

Vehicle Foam DRUG

Topical Foam

Vehicle Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (8)

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Dermatology Associates of Knoxville

Knoxville, Tennessee, 37917, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796.

  PMID: 31424709 DERIVED

Results Point of Contact

• Title: Clinical Research Director
• Organization: Therapeutics, Inc.

projectmanager@therapeuticsinc.com

858-571-1800

Study Officials

• Anthony Andrasfay

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2017
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-10

Locations

US (8)