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

Phase 1

Terminated

• Conditions: Moderate-to-severe Atopic Dermatitis; Atopic Dermatitis; AD
• Interventions: Drug: IMG-007; Drug: Placebo

• Registration Number: NCT05984784
• Lead Sponsor: Inmagene LLC

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-02
• Study Start: 2023-08-09
• Study First Posted: 2023-08-09
• Primary Completion: 2024-04-26
• Study Completion: 2024-04-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1 IMG-007 Dose 1	IMG-007	IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
Cohort 2 IMG-007 Dose 2	IMG-007	IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Placebo	Placebo	Placebo will be administered intravenously 3 times over 4 weeks

Primary Outcome Measures

Name	Time	Method
Evaluation of Adverse Events in Participants	Baseline, Week 24	To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Characterization	Baseline, Week 24	To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
Evaluation of Eczema Area and Severity Index (EASI)	Baseline, Week 12	To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)

Trial Locations

Locations (11)

Amicis Research Center; 🇺🇸 Valencia, California, United States

Medical Research Center of Miami II Inc; 🇺🇸 Miami, Florida, United States

Optimal Research Sites; 🇺🇸 Orange City, Florida, United States

USF Carol and Frank Morsani Center for Advanced Healthcare; 🇺🇸 Tampa, Florida, United States

Revival Research Institute, LLC; 🇺🇸 Troy, Michigan, United States

Markowitz Medical, LLC; 🇺🇸 New York, New York, United States

Central Sooner Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Paddington Testing Co, Inc; 🇺🇸 Philadelphia, Pennsylvania, United States

Brunswick Dermatology Center; 🇨🇦 Fredericton, New Brunswick, Canada

DermEffects; 🇨🇦 London, Ontario, Canada

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