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IDP-124

Phase 3

Atopic Dermatitis | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: May 8, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment666

FDA Designations

No designations recorded

Clinical trial landscape

IDP-124 · 2 trials · 1 indication

Phase 3 2
NCT03058783Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult SubjectsAtopic Dermatitis
COMPLETED328 Analytics
NCT03002571Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)Atopic Dermatitis
COMPLETED338 Analytics
PHASE3COMPLETED
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Atopic DermatitisUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
Baseline to Week 6

Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.

Secondary Endpoints

Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
Baseline to Week 10
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Baseline to Week 10
Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"
Baseline to Week 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IDP-124 LotionEXPERIMENTALIDP-124 Lotion, twice-daily application
IDP-124 Vehicle LotionACTIVE_COMPARATORIDP-124 Vehicle Lotion, twice-daily application

Interventions

NameTypeDescription
IDP-124 LotionDRUGIDP-124 Lotion, twice-daily application
IDP-124 Vehicle LotionDRUGIDP-124 Vehicle Lotion, twice-daily application
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female at least 2 years of age and older * Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent durin...

Countries:United States
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Frequently asked questions about IDP-124

What is IDP-124 used for?

IDP-124 is an investigational small molecule being developed for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects. It is formulated as a lotion and is currently in Phase 3 clinical development. The drug has not been approved by the FDA and remains under investigation.

Who makes IDP-124?

IDP-124 is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting Phase 3 clinical trials to evaluate the efficacy and safety of IDP-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects.

What phase is IDP-124 in?

IDP-124 is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 666 subjects. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is IDP-124 in?

IDP-124 has been studied in two completed Phase 3 clinical trials: NCT03002571 with 338 participants and NCT03058783 with 328 participants. Both trials evaluated the efficacy and safety of IDP-124 lotion for moderate to severe atopic dermatitis in pediatric and adult subjects in the United States.

Is IDP-124 FDA approved?

No, IDP-124 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. Two Phase 3 trials have been completed, but the drug has not received regulatory approval for the treatment of atopic dermatitis or any other condition.