Clinical trial NCT03759197: A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis
Official title: A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Efficacy and Safety of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis Receiving Up to Four Weeks of Twice-Daily Treatment (Study 305)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 206
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 305) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).


Eligibility criteria: Inclusion Criteria:

1. Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas).
4. Subject has moderate to severe plaque psoriasis.
5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
6. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have 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 palmar/plantar psoriasis.
4. Subject is pregnant, lactating, or is planning to become pregnant during the study.
5. Subject is currently enrolled in an investigational drug or device study.
6. Subject has been previously enrolled in this study and treated with a test article.

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Primary outcomes:
measure: Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
timeFrame: Day 29
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 29
measure: Change from Baseline in pruritus score
timeFrame: Day 29
measure: IGA "treatment success" at Day 15
timeFrame: Day 15
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Site 06
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 09
state: California
city: Fremont
country: United States
facility: Site 07
state: California
city: Aventura
country: United States
facility: Site 02
state: Florida
city: Brandon
country: United States
facility: Site 04
state: Florida
city: Largo
country: United States
facility: Site 01
state: Florida
city: North Miami Beach
country: United States
facility: Site 05
state: Florida
city: Albany
country: United States
facility: Site 08
state: Indiana
city: Plainfield
country: United States
facility: Site 03
state: Indiana
city: Louisville
country: United States
facility: Site 11
state: Kentucky
city: Metairie
country: United States
facility: Site 12
state: Louisiana
city: Fountain Inn
country: United States
facility: Site 10
state: South Carolina
Study officials:
affiliation: Therapeutics, Inc.
name: Tony Andrasfay
role: STUDY_DIRECTOR
References: