Back to resultsA Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
188-0551 Spray
RLD
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent.
- Subject has provided written informed consent.
- Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA).
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Exclusion Criteria:
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation.
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.
Sites / Locations
- TI Site #13
- TI Site #12
- TI Site #11
- TI Site #31
- TI Site #32
- TI Site #23
- TI Site #22
- TI Site #21
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
188-0551 Spray
Reference Listed Drug (RLD)
Arm Description
Investigational Topical Spray Product
FDA Approved Topical Cream
Outcomes
Primary Outcome Measures
The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test
A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04080206
Brief Title
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
Official Title
An Open Label, Comparative Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of 188-0551 Spray Versus Reference Listed Drug (RLD) Applied Every 12 Hours for 2 Weeks in Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
188-0551 Spray
Arm Type
Experimental
Arm Description
Investigational Topical Spray Product
Arm Title
Reference Listed Drug (RLD)
Arm Type
Active Comparator
Arm Description
FDA Approved Topical Cream
Intervention Type
Drug
Intervention Name(s)
188-0551 Spray
Intervention Description
Applied topically twice daily for two weeks
Intervention Type
Drug
Intervention Name(s)
RLD
Intervention Description
Applied topically twice daily for two weeks
Primary Outcome Measure Information:
Title
The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test
Description
A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent.
Subject has provided written informed consent.
Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA).
Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Exclusion Criteria:
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation.
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation.
Subject is currently enrolled in an investigational drug or device study.
Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.
Facility Information:
Facility Name
TI Site #13
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
TI Site #12
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
TI Site #11
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
TI Site #31
City
Batumi
Country
Georgia
Facility Name
TI Site #32
City
Tbilisi
Country
Georgia
Facility Name
TI Site #23
City
Lviv
Country
Ukraine
Facility Name
TI Site #22
City
Rivne
Country
Ukraine
Facility Name
TI Site #21
City
Zaporizhzhya
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
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