A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (305)
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| ClinicalTrials.gov Identifier: NCT03759197 |
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Recruitment Status :
Completed
First Posted : November 29, 2018
Last Update Posted : February 25, 2020
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Sponsor:
Therapeutics, Inc.
Information provided by (Responsible Party):
Therapeutics, Inc.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: 188-0551 Spray Drug: Vehicle Spray | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 206 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 305) |
| Actual Study Start Date : | November 26, 2018 |
| Actual Primary Completion Date : | August 27, 2019 |
| Actual Study Completion Date : | August 27, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: 188-0551 Spray
Topical Spray containing active drug |
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Placebo Comparator: Vehicle Spray
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
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Drug: Vehicle Spray
Topical Spray containing no active drug |
Primary Outcome Measures :
- Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) [ 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 :
- 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.
- 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."
- 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:
- Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
- Subject has provided written informed consent.
- 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).
- Subject has moderate to severe plaque psoriasis.
- 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:
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- Subject has palmar/plantar psoriasis.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- 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): NCT03759197
Locations
| United States, Arkansas | |
| Site 06 | |
| Fort Smith, Arkansas, United States, 72916 | |
| United States, California | |
| Site 09 | |
| Fountain Valley, California, United States, 92708 | |
| Site 07 | |
| Fremont, California, United States, 94538 | |
| United States, Florida | |
| Site 02 | |
| Aventura, Florida, United States, 33180 | |
| Site 04 | |
| Brandon, Florida, United States, 33544 | |
| Site 01 | |
| Largo, Florida, United States, 33770 | |
| Site 05 | |
| North Miami Beach, Florida, United States, 33162 | |
| United States, Indiana | |
| Site 08 | |
| Albany, Indiana, United States, 47150 | |
| Site 03 | |
| Plainfield, Indiana, United States, 46168 | |
| United States, Kentucky | |
| Site 11 | |
| Louisville, Kentucky, United States, 40241 | |
| United States, Louisiana | |
| Site 12 | |
| Metairie, Louisiana, United States, 70006 | |
| United States, South Carolina | |
| Site 10 | |
| Fountain Inn, South Carolina, United States, 92708 | |
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
| Study Director: | Tony Andrasfay | Therapeutics, Inc. |
| Responsible Party: | Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03759197 |
| Other Study ID Numbers: |
188-0551-305 |
| First Posted: | November 29, 2018 Key Record Dates |
| Last Update Posted: | February 25, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |