Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: IDP-122 Lotion; Drug: IDP-122 Vehicle Lotion

• Registration Number: NCT02514577
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).

Detailed Description

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-03
• Study Start: 2015-11-07
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Disposition First Submitted: 2018-02-13
• Disposition First Submitted QC: 2018-02-13
• Disposition First Posted: 2018-02-15
• Status Verified: 2020-01
• Results First Submitted: 2020-01-14
• Results First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Results First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Male or female, of any race, at least 18 years of age (inclusive).
• Freely provides both verbal and written informed consent.
• Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
• Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).

Key

Exclusion Criteria

• Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
• Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
• Is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-122 Lotion	IDP-122 Lotion	Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.
IDP-122 Vehicle Lotion	IDP-122 Vehicle Lotion	Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success at Week 8	Week 8	Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12	Weeks 2, 4, 6, and 12 (4-week follow-up)	Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.

Trial Locations

Locations (15)

Valeant Site 11; 🇺🇸 Hot Springs, Arkansas, United States

Valeant Site 1; 🇺🇸 Encinitas, California, United States

Valeant Site 12; 🇺🇸 Santa Rosa, California, United States

Valeant Site 9; 🇺🇸 Raleigh, North Carolina, United States

Valeant Site 3; 🇺🇸 Austin, Texas, United States

Valeant Site 14; 🇺🇸 Spokane, Washington, United States

Valeant Site 4; 🇺🇸 Ann Arbor, Michigan, United States

Valeant Site 7; 🇺🇸 Boise, Idaho, United States

Valeant Site 6; 🇺🇸 Rockville, Maryland, United States

Valeant Site 8; 🇺🇸 Clarkston, Michigan, United States

Valeant Site 5; 🇺🇸 Knoxville, Tennessee, United States

Valeant Site 15; 🇺🇸 Las Vegas, Nevada, United States

Valeant Site 13; 🇺🇸 Atlanta, Georgia, United States

Valeant Site 10; 🇺🇸 Encino, California, United States

Valeant Site 2; 🇺🇸 San Antonio, Texas, United States