A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema
• Interventions: Drug: IMG-007; Drug: Placebo

• Registration Number: NCT07037901
• Lead Sponsor: Inmagene LLC

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

Detailed Description

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 52 weeks.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-17
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-11
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception
• Male participants must agree to use a highly effective method of contraception
• EASI score ≥16
• vIGA-AD score ≥3
• ≥10% body surface area (BSA) of AD involvement
• Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization

Key

Exclusion Criteria

• Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection
• Evidence of active or latent tuberculosis (TB)
• History of untreated or inadequately treated TB infection
• Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
• Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
• Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
• Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IMG-007 dose 1	IMG-007	Subcutaneous injection as per protocol.
IMG-007 dose 2	IMG-007	Subcutaneous injection as per protocol.
IMG-007 dose 3	IMG-007	Subcutaneous injection as per protocol.
Placebo Crossover	IMG-007	Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
Placebo Crossover	Placebo	Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in EASI at Week 20	Baseline, Week 20

Secondary Outcome Measures

Name	Time	Method
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
Incidence and severity of TEAE including treatment-emergent SAEs	Baseline, End of Study

Trial Locations

Locations (3)

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Arlington Dermatology; 🇺🇸 Rolling Meadows, Illinois, United States

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States