drugset / Trial / NCT04080206

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

NCT04080206 ↗

Phase 2 Completed 55 enrolled Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-04-07
Primary completion
2021-01-20
Completion
2021-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject 188-0551 Unknown — Topical
Comparator RLD Unknown — Topical

Indications