A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080206
• Other study ID #: 188-0551-204
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: May 2021
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 188-0551 Spray
Applied topically twice daily for two weeks
• RLD
Applied topically twice daily for two weeks

Locations

Country	Name	City	State
Georgia	TI Site #31	Batumi
Georgia	TI Site #32	Tbilisi
Ukraine	TI Site #23	Lviv
Ukraine	TI Site #22	Rivne
Ukraine	TI Site #21	Zaporizhzhya
United States	TI Site #11	Miami	Florida
United States	TI Site #13	Scottsdale	Arizona
United States	TI Site #12	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Georgia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 15