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

• ClinicalTrials.gov Identifier: NCT02514577
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Tracking Information

• First Submitted Date: July 31, 2015
• First Posted Date: August 3, 2015
• Results First Submitted Date: January 14, 2020
• Results First Posted Date: January 27, 2020
• Last Update Posted Date: January 27, 2020
• Actual Study Start Date: November 7, 2015
• Actual Primary Completion Date: May 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2020)

Percentage of Participants With Treatment Success at Week 8 [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: July 31, 2015): the percent of subjects with treatment success, defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". [ Time Frame: 3 months ]

Current Secondary Outcome Measures (submitted: January 14, 2020)

Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
• Official Title: 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
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Plaque Psoriasis

Intervention

• Drug: IDP-122 Lotion
  Topical lotion
  Other Name: HP 0.01%
• Drug: IDP-122 Vehicle Lotion
  Topical lotion. No active ingredient.

Study Arms

• Experimental: IDP-122 Lotion
  Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
  Intervention: Drug: IDP-122 Lotion
• Active Comparator: IDP-122 Vehicle Lotion
  Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
  Intervention: Drug: IDP-122 Vehicle Lotion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 31, 2017): 217
• Original Estimated Enrollment (submitted: July 31, 2015): 210
• Actual Study Completion Date: May 1, 2017
• Actual Primary Completion Date: May 1, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02514577
• Other Study ID Numbers: V01-122A-301
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Bausch Health Americas, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Bausch Health Americas, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Binu j Alexander; Valeant Pharmaceuticals

• PRS Account: Bausch Health Americas, Inc.
• Verification Date: January 2020