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

NCT04080206 | Completed Phase 2 FDA Drug

• 1 other identifier: 188-0551-204
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 8

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

188-0551 Spray

EXPERIMENTAL

Investigational Topical Spray Product

Drug: 188-0551 Spray

Reference Listed Drug (RLD)

ACTIVE COMPARATOR

FDA Approved Topical Cream

Drug: RLD

Interventions

188-0551 Spray DRUG

Applied topically twice daily for two weeks

188-0551 Spray

RLD DRUG

Applied topically twice daily for two weeks

Reference Listed Drug (RLD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (8)

TI Site #13

Scottsdale, Arizona, 85258, United States

Location

TI Site #12

Thousand Oaks, California, 91320, United States

Location

TI Site #11

Miami, Florida, 33147, United States

Location

TI Site #31

Batumi, Georgia

Location

TI Site #32

Tbilisi, Georgia

Location

TI Site #23

Lviv, Ukraine

Location

TI Site #22

Rivne, Ukraine

Location

TI Site #21

Zaporizhzhya, Ukraine

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: April 7, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); GE (2); UA (3)