Clinical trial NCT02742441: A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
measure: Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
timeFrame: Day 15
Other outcomes:
measure: Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
timeFrame: Day 8
measure: Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
timeFrame: Day 8
measure: Change From Baseline in Pruritus Score
timeFrame: Day 15
measure: Changes in Percent BSA With Active Psoriasis in the Treatment Area
timeFrame: Day 15
Locations:
city: Fort Smith
country: United States
facility: Site 14
state: Arkansas
city: Hot Springs
country: United States
facility: Site 01
state: Arkansas
city: Encino
country: United States
facility: Site 17
state: California
city: Denver
country: United States
facility: Site 19
state: Colorado
city: Brandon
country: United States
facility: Site 16
state: Florida
city: Clearwater
country: United States
facility: Site 15
state: Florida
city: Miami Lakes
country: United States
facility: Site 20
state: Florida
city: North Miami Beach
country: United States
facility: Site 11
state: Florida
city: Pinellas Park
country: United States
facility: Site 12
state: Florida
city: Carmel
country: United States
facility: Site 10
state: Indiana
city: New Albany
country: United States
facility: Site 06
state: Indiana
city: Quincy
country: United States
facility: Site 13
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site 07
state: Michigan
city: Saint Joseph
country: United States
facility: Site 02
state: Missouri
city: Wilmington
country: United States
facility: Site 08
state: North Carolina
city: Gahanna
country: United States
facility: Site 04
state: Ohio
city: Nashville
country: United States
facility: Site 05
state: Tennessee
city: Austin
country: United States
facility: Site 09
state: Texas
city: San Antonio
country: United States
facility: Site 18
state: Texas
city: Norfolk
country: United States
facility: Site 21
state: Virginia
city: Spokane
country: United States
facility: Site 03
state: Washington
Study officials:
References:
citation: 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.