A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

NCT02742441 | Completed Phase 3 Results

• 1 other identifier: 122-0551-310
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 21

Brief Summary

This Phase 3 study (Study 310) 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 taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 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)

• Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)

  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

  Day 15

Study Arms (2)

122-0551 Foam

EXPERIMENTAL

122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam

Drug: 122-0551 Foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam

Drug: Vehicle Foam

Interventions

122-0551 Foam DRUG

Topical Foam containing active drug

122-0551 Foam

Vehicle Foam DRUG

Topical Foam containing no active drug

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 is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit.
• Subject has provided written informed consent.
• Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
• Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
• Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
• Females must be post-menopausal , surgically sterile or use an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.

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 the Baseline Visit.
• 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 the Baseline Visit.
• Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value.
• Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease.
• Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit.
• Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
• Subject is currently using lithium or Plaquenil (hydroxychloroquine).
• Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
• Subject has a history of sensitivity to any of the ingredients in the test articles.
• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (21)

Site 14

Fort Smith, Arkansas, 72916, United States

Location

Site 01

Hot Springs, Arkansas, 71913, United States

Location

Site 17

Encino, California, 91436, United States

Location

Site 19

Denver, Colorado, 80220, United States

Location

Site 16

Brandon, Florida, 33511, United States

Location

Site 15

Clearwater, Florida, 33756, United States

Location

Site 20

Miami Lakes, Florida, 33014, United States

Location

Site 11

North Miami Beach, Florida, 33162, United States

Location

Site 12

Pinellas Park, Florida, 33781, United States

Location

Site 10

Carmel, Indiana, 46032, United States

Location

Site 06

New Albany, Indiana, 47150, United States

Location

Site 13

Quincy, Massachusetts, 02169, United States

Location

Site 07

Ann Arbor, Michigan, 48103, United States

Location

Site 02

Saint Joseph, Missouri, 64506, United States

Location

Site 08

Wilmington, North Carolina, 28405, United States

Location

Site 04

Gahanna, Ohio, 43230, United States

Location

Site 05

Nashville, Tennessee, 37215, United States

Location

Site 09

Austin, Texas, 78746, United States

Location

Site 18

San Antonio, Texas, 78229, United States

Location

Site 21

Norfolk, Virginia, 23507, United States

Location

Site 03

Spokane, Washington, 99202, 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, Therapeutics, Inc.
• Organization: Therapeutics, Inc.

clinicalresearch@therapeuticsinc.com

858-571-1800

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: June 1, 2016
• Primary Completion: February 27, 2017
• Study Completion: June 16, 2017
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

US (21)