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OpenTrials
Completed

NCT Number: NCT04080206

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TI Site #31, Batumi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

188-0551 Spray

Drug

Applied topically twice daily for two weeks

RLD

Drug

Applied topically twice daily for two weeks

Primary outcomes

  1. The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test

    Time frame: Day 15

    A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).

Sponsors and collaborators

Lead sponsor

Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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