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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04080206

Enrollment

Registered

2019-09-06

Start date

2020-04-07

Completion date

2021-01-20

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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.

Interventions

DRUG188-0551 Spray

Applied topically twice daily for two weeks

DRUGRLD

Applied topically twice daily for two weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test	Day 15	A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).

Countries

Georgia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026