A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

NCT02367911 | Completed Phase 3 Results

• 1 other identifier: 122-0551-305
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 9

Brief Summary

This Phase 3 study 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).

  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)

• Proportion of Subjects With IGA "Treatment Success"

  Day 8

• Proportion 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

  Day 15

Study Arms (2)

Active Arm

EXPERIMENTAL

122-0551 Foam, topically applied twice daily for two weeks

Drug: 122-0551 Foam

Vehicle Arm

PLACEBO COMPARATOR

Vehicle Foam, topically applied twice daily for two weeks

Drug: Vehicle Foam

Interventions

122-0551 Foam DRUG

122-0551 Foam applied twice daily to treat psoriasis

Active Arm

Vehicle Foam DRUG

Vehicle Foam applied twice daily to treat psoriasis

Vehicle Arm

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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (9)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

UCSD Dermatology

San Diego, California, 92122, United States

Location

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

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 20, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2017
• Last Updated: November 8, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-10

Locations

US (9)