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

NCT05984784 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: IMG-007-201
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Atopic Dermatitis; Moderate-to-severe Atopic Dermatitis; AD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of Adverse Events in Participants

  To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)

  Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.

Secondary Outcomes (2)

• Pharmacokinetic Characterization

  Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).

• Evaluation of Eczema Area and Severity Index (EASI)

  Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.

Study Arms (3)

Cohort 1 IMG-007 Dose 1

EXPERIMENTAL

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

Drug: IMG-007

Cohort 2 IMG-007 Dose 2

EXPERIMENTAL

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

Drug: IMG-007

Placebo

PLACEBO COMPARATOR

Placebo will be administered intravenously 3 times over 4 weeks

Drug: Placebo

Interventions

Placebo DRUG

Drug: Placebo Intravenous Infusion

Placebo

IMG-007 DRUG

Drug: IMG-007 Intravenous Infusion

Cohort 1 IMG-007 Dose 1; Cohort 2 IMG-007 Dose 2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inmagene LLC: lead

Study Sites (12)

Amicis Research Center

Northridge, California, 91324, United States

Location

Amicis Research Center

Valencia, California, 91355, United States

Location

Medical Research Center of Miami II Inc

Miami, Florida, 33134, United States

Location

Optimal Research Sites

Orange City, Florida, 32763, United States

Location

USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Markowitz Medical, LLC

New York, New York, 10128, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Brunswick Dermatology Center

Fredericton, New Brunswick, E3B 1G9, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Centre de Recherche Saint-Louis (Québec)

Québec, G1W4R4, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Results Point of Contact

• Title: Clinical Trials Lead
• Organization: Inmagene LLC

ClinicalTrials@imagenebio.com

(858) 345-6927

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: August 9, 2023
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (9); CA (3)