RECRUITING

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

Conditions

Atopic Dermatitis Atopic Dermatitis Eczema Eczema IMG-007 Dermatitis, Atopic Dermatitis Skin Diseases Immune System Diseases Dermatologic Agents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Quick Facts

Study Start:2025-06-17

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07037901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

ADAPTIVE Study Lead

CONTACT

(858) 345-6927

ADAPTIVE_StudyLead@inmagenebio.com

Study Locations (Sites)

Antelope Valley Clinical Trials

Lancaster, California, 93534

United States

Arlington Dermatology

Rolling Meadows, Illinois, 60008

United States

Oregon Dermatology and Research Center

Portland, Oregon, 97210

United States

Collaborators and Investigators

Sponsor: Inmagene LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17

Study Completion Date2027-10

Study Record Updates

Study Start Date2025-06-17

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

IMG-007
Atopic Dermatitis
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Immune System Diseases
Dermatologic Agents

Additional Relevant MeSH Terms

Atopic Dermatitis
Atopic Dermatitis Eczema
Eczema