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

NCT02514577 | Completed Phase 3 Results

• 1 other identifier: V01-122A-301
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 15

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).

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12

  Weeks 2, 4, 6, and 12 (4-week follow-up)

Study Arms (2)

IDP-122 Lotion

EXPERIMENTAL

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

Drug: IDP-122 Lotion

IDP-122 Vehicle Lotion

ACTIVE COMPARATOR

Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.

Drug: IDP-122 Vehicle Lotion

Interventions

IDP-122 Lotion DRUG

Topical lotion

Also known as: HP 0.01%

IDP-122 Lotion

IDP-122 Vehicle Lotion DRUG

Topical lotion. No active ingredient.

IDP-122 Vehicle Lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (15)

Valeant Site 11

Hot Springs, Arkansas, 71901, United States

Location

Valeant Site 1

Encinitas, California, 92023, United States

Location

Valeant Site 10

Encino, California, 91436, United States

Location

Valeant Site 12

Santa Rosa, California, 95401, United States

Location

Valeant Site 13

Atlanta, Georgia, 30301, United States

Location

Valeant Site 7

Boise, Idaho, 83701, United States

Location

Valeant Site 6

Rockville, Maryland, 20847, United States

Location

Valeant Site 4

Ann Arbor, Michigan, 48103, United States

Location

Valeant Site 8

Clarkston, Michigan, 48346, United States

Location

Valeant Site 15

Las Vegas, Nevada, 89101, United States

Location

Valeant Site 9

Raleigh, North Carolina, 27601, United States

Location

Valeant Site 5

Knoxville, Tennessee, 37901, United States

Location

Valeant Site 3

Austin, Texas, 73301, United States

Location

Valeant Site 2

San Antonio, Texas, 78201, United States

Location

Valeant Site 14

Spokane, Washington, 99201, United States

Location

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc.

aloncaric@bauschhealth.com

1-510-259-5284

Study Officials

• Binu j Alexander

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 3, 2015
• Study Start: November 7, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (15)