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IDP-122

Phase 3

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

IDP-122 target and mechanism

ModalitySmall molecule

Also known as IDP-122 Lotion

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

IDP-122 clinical trials

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?

IDP-122 is an investigational small molecule lotion being developed for the treatment of plaque psoriasis. It is also known as IDP-122 Lotion. Bausch Health Companies Inc. (ticker BHC) is developing the asset, which has completed Phase 3 clinical development in adults with plaque psoriasis.

What is IDP-122 used for?

IDP-122 is being studied for the treatment of plaque psoriasis, a common inflammatory skin condition. Both completed Phase 3 trials enrolled adults 18 years and older with plaque psoriasis in the United States. The program has not reported an approved indication, so the use remains investigational.

Who makes IDP-122?

IDP-122 is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company sponsored the Phase 3 plaque psoriasis program for the asset, including the two completed trials that together enrolled 430 participants in the United States.

What phase is IDP-122 in?

IDP-122 has completed Phase 3 development for plaque psoriasis. Two Phase 3 trials, both randomized, double-blind and placebo-controlled, have finished, and no trials are currently listed as active. The asset is investigational and has not been approved for marketing based on the information available.

What clinical trials is IDP-122 in?

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

Is IDP-122 the same as IDP-122 Lotion?

Yes, IDP-122 Lotion is another name for IDP-122. The two names refer to the same investigational small molecule product developed by Bausch Health Companies Inc. for plaque psoriasis, so searches for either name point to the same Phase 3 asset.