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

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: 122-0551 Foam; Drug: Vehicle Foam

• Study Type: Interventional
• Enrollment (Actual): 409
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Site 14
    • Hot Springs, Arkansas, United States, 71913
      • Site 01
  • California
    • Encino, California, United States, 91436
      • Site 17
  • Colorado
    • Denver, Colorado, United States, 80220
      • Site 19
  • Florida
    • Brandon, Florida, United States, 33511
      • Site 16
    • Clearwater, Florida, United States, 33756
      • Site 15
    • Miami Lakes, Florida, United States, 33014
      • Site 20
    • North Miami Beach, Florida, United States, 33162
      • Site 11
    • Pinellas Park, Florida, United States, 33781
      • Site 12
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Site 10
    • New Albany, Indiana, United States, 47150
      • Site 06
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Site 13
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Site 07
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Site 02
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Site 08
  • Ohio
    • Gahanna, Ohio, United States, 43230
      • Site 04
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Site 05
  • Texas
    • Austin, Texas, United States, 78746
      • Site 09
    • San Antonio, Texas, United States, 78229
      • Site 18
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Site 21
  • Washington
    • Spokane, Washington, United States, 99202
      • Site 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit.
2. Subject has provided written informed consent.
3. 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.
4. 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).
5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
6. 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.

Exclusion Criteria:

1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
11. 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.
12. Subject has a history of sensitivity to any of the ingredients in the test articles.
13. Subject is pregnant, lactating, or is planning to become pregnant during the study.
14. Subject is currently enrolled in an investigational drug or device study.
15. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
16. Subject has been previously enrolled in this study and treated with a test article.
17. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 122-0551 Foam; 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam	Drug: 122-0551 Foam; Topical Foam containing active drug
Placebo Comparator: Vehicle Foam; Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam	Drug: Vehicle Foam; Topical Foam containing no active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)	Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.	Day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.	Day 15
Changes in Percent BSA With Active Psoriasis in the Treatment Area	The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive.	Day 15

Collaborators and Investigators

• Sponsor: Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 122-0551-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided