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NCT07037901PHASE2Recruiting

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

Inmagene LLC

Start Date

6/17/2025

Completion Date

8/1/2028

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 48 weeks.

Eligibility Criteria

Age Range: 18 years to 74 years

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 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

Interventions

DRUG

IMG-007

DRUG

Placebo

Interested in This Trial?

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Conditions

Atopic DermatitisAtopic Dermatitis EczemaEczema

Locations

Inmagene Site 1

Lancaster, California 93534

United States

Inmagene Site 23

Los Angeles, California 90095

United States

Inmagene Site 19

Ocala, Florida 34470

United States

Inmagene Site 4

Tampa, Florida 33609

United States

Inmagene Site 2

Rolling Meadows, Illinois 60008

United States

Inmagene Site 6

Kew Gardens, New York 11415

United States

Inmagene Site 21

New York, New York 10029

United States

Inmagene Site 11

Woodbury, New York 11797

United States

Inmagene Site 20

Charlotte, North Carolina 28277

United States

Inmagene Site 10

Fargo, North Dakota 58103

United States

Inmagene Site 9

Columbus, Ohio 43213

United States

Inmagene Site 5

Mayfield Heights, Ohio 44124

United States

Inmagene Site 3

Portland, Oregon 97210

United States

Inmagene Site 12

Anderson, South Carolina 29621

United States

Inmagene Site 8

Southlake, Texas 76092

United States

Inmagene Site 7

Burien, Washington 698168

United States

Inmagene Site 15

Surrey, British Columbia V3R 6A7

Canada

Inmagene Site 22

Vancouver, British Columbia V6H 4B1

Canada

Inmagene Site 17

Greater Sudbury, Ontario P3C 1X8

Canada

Inmagene Site 13

Mississauga, Ontario L4Y 4C5

Canada

Inmagene Site 18

North Bay, Ontario P1B 3Z7

Canada

Inmagene Site 14

Montreal, Quebec H2X 2V1

Canada

Inmagene Site 16

Saskatoon, Saskatchewan S7K 2C1

Canada