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IDP-122

Phase 3

Plaque Psoriasis | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Jan 27, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment430

FDA Designations

No designations recorded

Clinical trial landscape

IDP-122 · 2 trials · 1 indication

Phase 3 2
NCT02514577Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque PsoriasisPlaque Psoriasis
COMPLETED217 Analytics
NCT02515097Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque PsoriasisPlaque Psoriasis
COMPLETED213 Analytics
PHASE3COMPLETED
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Weeks 2, 4, 6, and 12 (4-week follow-up)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
IDP-122 LotionDRUGTopical lotion
IDP-122 Vehicle LotionDRUGTopical lotion. No active ingredient.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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%. Th...

Countries:United States
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Frequently asked questions about IDP-122

What is IDP-122 used for?

IDP-122 is an investigational small molecule being developed for the treatment of plaque psoriasis, a chronic skin condition characterized by red, scaly patches. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes IDP-122?

IDP-122 is being developed by Bausch Health Companies Inc., a company publicly traded under the ticker symbol BHC. The drug is in Phase 3 clinical trials for plaque psoriasis.

What phase is IDP-122 in?

IDP-122 is in Phase 3 clinical development for plaque psoriasis. It is an investigational drug and has not yet received regulatory approval. Two Phase 3 trials have been completed, each enrolling over 200 participants.

What clinical trials is IDP-122 in?

IDP-122 has been studied in two completed Phase 3 clinical trials: NCT02514577, which enrolled 217 participants, and NCT02515097, which enrolled 213 participants. Both trials were randomized, double-blind, placebo-controlled studies conducted in the United States in adults aged 18 years and older with plaque psoriasis.

Is IDP-122 FDA approved?

IDP-122 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for plaque psoriasis. The two Phase 3 trials have been completed, but the drug has not yet received marketing authorization.