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IMG-007

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |ImageneBio, Inc.|Last Updated: Feb 19, 2026

Target and mechanism

Molecular targetOX40
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

IMG-007 · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT07037901A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic DermatitisAtopic Dermatitis
RECRUITING220 Analytics
PHASE2RECRUITING
A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean percent change from baseline in EASI at Week 20
Baseline, Week 20
Evaluation of Adverse Events in Participants
Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.

To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.

Secondary Endpoints

Mean percent change from baseline in EASI at Week 16
Baseline, Week 16
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 16 and Week 20, respectively
Week 16, Week 20
Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 16 and Week 20, respectively
Week 16, Week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMG-007 dose 1EXPERIMENTALSubcutaneous injection as per protocol.
IMG-007 dose 2EXPERIMENTALSubcutaneous injection as per protocol.
IMG-007 dose 3EXPERIMENTALSubcutaneous injection as per protocol.
Placebo CrossoverPLACEBO_COMPARATORSubcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
IMG-007 Dose 1 (300 mg)EXPERIMENTALIMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks
IMG-007 Dose 2 (600 mg)EXPERIMENTALIMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks

Interventions

NameTypeDescription
IMG-007DRUGParticipants will receive IMG-007 subcutaneously.
PlaceboDRUGParticipants will receive a placebo subcutaneously.
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: * Moderate-to-severe AD * Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable * Female participants who are not pregnant or...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT07037901studyFirstPostDate: changed

Frequently asked questions about IMG-007

What is IMG-007 used for?

IMG-007 is an investigational small molecule being developed for the treatment of atopic dermatitis and alopecia areata (AA). It is currently in clinical development for moderate-to-severe atopic dermatitis and has completed a Phase 1 study in adult alopecia areata participants.

What does IMG-007 target?

IMG-007 targets OX40, a receptor involved in immune responses. By targeting OX40, IMG-007 aims to modulate immune activity relevant to inflammatory and autoimmune conditions such as atopic dermatitis and alopecia areata.

Who makes IMG-007?

IMG-007 is being developed by ImageneBio, Inc., a biopharmaceutical company. The company's ticker symbol is IMA.

What phase is IMG-007 in?

IMG-007 is in Phase 2 clinical development for moderate-to-severe atopic dermatitis, with a Phase 2 trial currently recruiting participants. A Phase 1 study in alopecia areata has been completed. IMG-007 is investigational and not yet approved by regulatory authorities.

What clinical trials is IMG-007 in?

IMG-007 is being studied in two clinical trials. NCT06060977 is a completed Phase 1 study in adult alopecia areata participants. NCT07037901 is a Phase 2 trial currently recruiting participants with moderate-to-severe atopic dermatitis.

Is IMG-007 the same as any other drug?

No alternative names for IMG-007 have been disclosed. It is identified solely as IMG-007 in clinical trial records and by its developer, ImageneBio, Inc.