NCT05984784

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

A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Inmagene LLC · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Moderate-to-severe Atopic Dermatitis
• AD

Interventions

Type	Name	Description
DRUG	Placebo	Drug: Placebo Intravenous Infusion
DRUG	IMG-007	Drug: IMG-007 Intravenous Infusion

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2023-08-09
• Last updated: 2025-11-06
• Results posted: 2025-11-06

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study