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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

NCT ID: NCT05984784

Last Updated: 2025-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2024-04-26

Brief Summary

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The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.

Detailed Description

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This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.

Conditions

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Atopic Dermatitis Moderate-to-severe Atopic Dermatitis AD

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 IMG-007 Dose 1

IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Drug: IMG-007 Intravenous Infusion

Cohort 2 IMG-007 Dose 2

IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Drug: IMG-007 Intravenous Infusion

Placebo

Placebo will be administered intravenously 3 times over 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug: Placebo Intravenous Infusion

Interventions

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Placebo

Drug: Placebo Intravenous Infusion

Intervention Type DRUG

IMG-007

Drug: IMG-007 Intravenous Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged ≥ 18 and \< 75 years.
* 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.

Exclusion Criteria

* Known 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 at the Screening visit.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inmagene LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amicis Research Center

Northridge, California, United States

Site Status

Amicis Research Center

Valencia, California, United States

Site Status

Medical Research Center of Miami II Inc

Miami, Florida, United States

Site Status

Optimal Research Sites

Orange City, Florida, United States

Site Status

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Site Status

Revival Research Institute, LLC

Troy, Michigan, United States

Site Status

Markowitz Medical, LLC

New York, New York, United States

Site Status

Central Sooner Research

Oklahoma City, Oklahoma, United States

Site Status

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, United States

Site Status

Brunswick Dermatology Center

Fredericton, New Brunswick, Canada

Site Status

DermEffects

London, Ontario, Canada

Site Status

Centre de Recherche Saint-Louis (Québec)

Québec, , Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IMG-007-201

Identifier Type: -

Identifier Source: org_study_id