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

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis

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).

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: IDP-122 Lotion; Drug: IDP-122 Vehicle Lotion

Detailed Description

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92701
      • Valeant Site 14
  • Florida
    • Boynton Beach, Florida, United States, 33424
      • Valeant Site 02
    • Clearwater, Florida, United States, 33755
      • Valeant Site 10
    • Tampa, Florida, United States, 33603
      • Valeant Site 1
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Valeant Site 07
  • Kansas
    • Olathe, Kansas, United States, 66051
      • Valeant Site 15
  • Minnesota
    • Fridley, Minnesota, United States, 55421
      • Valeant Site 08
  • Nebraska
    • Omaha, Nebraska, United States, 68022
      • Valeant Site 13
  • New York
    • New York, New York, United States, 10001
      • Valeant Site 04
    • Stony Brook, New York, United States, 11790
      • Valeant Site 12
  • North Carolina
    • High Point, North Carolina, United States, 27260
      • Valeant Site 05
  • Tennessee
    • Knoxville, Tennessee, United States, 37901
      • Valeant Site 11
  • Texas
    • Houston, Texas, United States, 77001
      • Valeant Site 03
    • San Antonio, Texas, United States, 78201
      • Valeant Site 09
  • Utah
    • West Jordan, Utah, United States, 84081
      • Valeant Site 06

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 in this assessment).

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-122 Lotion; Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.	Drug: IDP-122 Lotion; Medicated topical lotion; Other Names: HP 0.01%
Placebo Comparator: IDP-122 Vehicle Lotion; Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.	Drug: IDP-122 Vehicle Lotion; Vehicle topical lotion with no active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment Success at 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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12	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.	Weeks 2, 4, 6, and 12 (4-week follow-up)

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2015
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: V01-122A-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes