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

NCT ID: NCT02742441

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

122-0551 Foam

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

Group Type: EXPERIMENTAL

122-0551 Foam

Intervention Type: DRUG

Topical Foam containing active drug

Vehicle Foam

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Group Type: PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type: DRUG

Topical Foam containing no active drug

Interventions

122-0551 Foam

Topical Foam containing active drug

Intervention Type: DRUG

Vehicle Foam

Topical Foam containing no active drug

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 14

Fort Smith, Arkansas, United States

Site 01

Hot Springs, Arkansas, United States

Site 17

Encino, California, United States

Site 19

Denver, Colorado, United States

Site 16

Brandon, Florida, United States

Site 15

Clearwater, Florida, United States

Site 20

Miami Lakes, Florida, United States

Site 11

North Miami Beach, Florida, United States

Site 12

Pinellas Park, Florida, United States

Site 10

Carmel, Indiana, United States

Site 06

New Albany, Indiana, United States

Site 13

Quincy, Massachusetts, United States

Site 07

Ann Arbor, Michigan, United States

Site 02

Saint Joseph, Missouri, United States

Site 08

Wilmington, North Carolina, United States

Site 04

Gahanna, Ohio, United States

Site 05

Nashville, Tennessee, United States

Site 09

Austin, Texas, United States

Site 18

San Antonio, Texas, United States

Site 21

Norfolk, Virginia, United States

Site 03

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31424709 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

122-0551-310

Identifier Type: -

Identifier Source: org_study_id