A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

— 305  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759197
• Other study ID #: 188-0551-305
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: February 2020
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 188-0551 Spray
Topical Spray containing active drug
• Vehicle Spray
Topical Spray containing no active drug

Locations

Country	Name	City	State
United States	Site 08	Albany	Indiana
United States	Site 02	Aventura	Florida
United States	Site 04	Brandon	Florida
United States	Site 06	Fort Smith	Arkansas
United States	Site 10	Fountain Inn	South Carolina
United States	Site 09	Fountain Valley	California
United States	Site 07	Fremont	California
United States	Site 01	Largo	Florida
United States	Site 11	Louisville	Kentucky
United States	Site 12	Metairie	Louisiana
United States	Site 05	North Miami Beach	Florida
United States	Site 03	Plainfield	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)	The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).	Day 29
Secondary	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 29
Secondary	Change from Baseline in pruritus score	The proportion of subjects with =4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."	Day 29
Secondary	IGA "treatment success" at Day 15	The proportion of subjects with IGA "treatment success" at Day 15	Day 15