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NCT02514577

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

Completed Phase 3 Results posted Last updated 27 January 2020
What this trial tests

Phase 3 trial testing IDP-122 Lotion in Plaque Psoriasis in 217 participants. Completed in 1 May 2017.

Timeline
7 November 2015
Primary endpoint
1 May 2017
1 May 2017

Quick facts

Lead sponsorBausch Health Americas, Inc.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment217
Start date7 November 2015
Primary completion1 May 2017
Estimated completion1 May 2017
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Treatment Success at Week 8 Primary · 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.

GroupValue95% CI
IDP-122 Lotion36.5
IDP-122 Vehicle Lotion8.13
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 Secondary · 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.

Week 2
GroupValue95% CI
IDP-122 Lotion7.06
IDP-122 Vehicle Lotion0
Week 4
GroupValue95% CI
IDP-122 Lotion19.81
IDP-122 Vehicle Lotion2.77
Week 6
GroupValue95% CI
IDP-122 Lotion30.14
IDP-122 Vehicle Lotion7.93
Week 12
GroupValue95% CI
IDP-122 Lotion19.48
IDP-122 Vehicle Lotion6.69

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through Week 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IDP-122 Lotion
Serious: 1/142 (1%)
Deaths: 0/142
IDP-122 Vehicle Lotion
Serious: 3/72 (4%)
Deaths: 0/72

Serious adverse events (5 terms)

ReactionSystemIDP-122 LotionIDP-122 Vehicle Lotion
Lobar pneumoniaInfections and infestations
Anal fissureGastrointestinal disorders
Application site cellulitisInfections and infestations
DiverticulitisInfections and infestations
Cardiac failure chronicCardiac disorders

Most-reported serious reactions: Lobar pneumonia, Anal fissure, Application site cellulitis, Diverticulitis, Cardiac failure chronic.

Data from ClinicalTrials.gov NCT02514577 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Once-Daily Halobetasol Propionate 0.01% Lotion for Moderate-to-Severe Plaque Psoriasis: Phase 3 Analysis of Hispanic Participants.
    Desai SR, Glick B, Del Rosso JQ, Harris S, et al · · 2021 · cited 2× · PMID 33683083 · DOI 10.36849/jdd.5698

Verify or expand the search:

Other trials of IDP-122 Lotion

Trials testing the same drug.

Other recruiting trials for Plaque Psoriasis

Currently open trials in the same condition.

Other Bausch Health Americas, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02514577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing