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Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

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ClinicalTrials.gov Identifier: NCT03731052
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Brief Summary:
This Phase 3 study (Study 307) 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).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: 188-0551 Spray Drug: Vehicle Spray Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 307)
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Drug: 188-0551 Spray
188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Drug: 188-0551 Spray
Topical Spray containing active drug

Placebo Comparator: Vehicle Spray
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Drug: Vehicle Spray
Topical Spray containing no active drug




Primary Outcome Measures :
  1. Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success [ Time Frame: Day 29 ]
    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).


Secondary Outcome Measures :
  1. Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) [ Time Frame: Day 29 ]
    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.

  2. Change from Baseline in pruritus score [ Time Frame: Day 29 ]
    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."

  3. IGA "treatment success" at Day 15 [ Time Frame: Day 15 ]
    The proportion of subjects with IGA "treatment success" at Day 15.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731052


Contacts
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Contact: TI Clinical Operations 1-858-571-1800 ext 147 ClinicalResearch@therapeuticsinc.com

Locations
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United States, California
Site 04 Recruiting
Los Angeles, California, United States, 90045
Contact    858-571-6800 ext 147      
United States, Florida
Site 14 Recruiting
Ocala, Florida, United States, 34470
Contact    858-571-6800 ext 147      
United States, Georgia
Site 01 Recruiting
Macon, Georgia, United States, 31217
Contact    858-571-6800 ext 147      
United States, Illinois
Site 11 Recruiting
Rolling Meadows, Illinois, United States, 60008
Contact    858-571-6800 ext 147      
United States, Maryland
Site 13 Recruiting
Rockville, Maryland, United States, 20850
Contact    858-571-6800 ext 147      
United States, Michigan
Site 10 Recruiting
Clinton Township, Michigan, United States, 48038
Contact    858-571-6800 ext 147      
United States, Minnesota
Site 12 Recruiting
Fridley, Minnesota, United States, 55432
Contact    858-571-1800 ext 147      
United States, New York
Site 07 Recruiting
Rochester, New York, United States, 14623
Contact    858-571-1800 ext 147      
United States, North Carolina
Site 06 Recruiting
High Point, North Carolina, United States, 27262
Contact    858-571-6800 ext 147      
United States, Oklahoma
Site 05 Recruiting
Norman, Oklahoma, United States, 73071
Contact    858-571-6800 ext 147      
United States, Pennsylvania
Site 03 Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact    858-571-6800 ext 147      
United States, Texas
Site 15 Recruiting
Austin, Texas, United States, 78759
Contact    858-571-1800 ext 147      
Site 08 Recruiting
San Antonio, Texas, United States, 78229
Contact    858-571-6800 ext 147      
United States, Virginia
Site 02 Recruiting
Norfolk, Virginia, United States, 23502
Contact    858-571-6800 ext 147      
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
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Study Director: Tony Andrasfay Therapeutics, Inc.

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Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03731052     History of Changes
Other Study ID Numbers: 188-0551-307
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases