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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05984784
• Other study ID #: IMG-007-201
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 9, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Inmagene LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
Drug: Placebo Intravenous Infusion
• IMG-007
Drug: IMG-007 Intravenous Infusion

Locations

Country	Name	City	State
Canada	Brunswick Dermatology Center	Fredericton	New Brunswick
Canada	DermEffects	London	Ontario
Canada	Centre de Recherche Saint-Louis (Québec)	Québec
United States	Medical Research Center of Miami II Inc	Miami	Florida
United States	Markowitz Medical, LLC	New York	New York
United States	Amicis Research Center	Northridge	California
United States	Central Sooner Research	Oklahoma City	Oklahoma
United States	Optimal Research Sites	Orange City	Florida
United States	Paddington Testing Co, Inc	Philadelphia	Pennsylvania
United States	USF Carol and Frank Morsani Center for Advanced Healthcare	Tampa	Florida
United States	Revival Research Institute, LLC	Troy	Michigan
United States	Amicis Research Center	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Inmagene LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline, Week 24
Secondary	Pharmacokinetic Characterization	To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants	Baseline, Week 24
Secondary	Pharmacokinetic Characterization	To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants	Baseline, Week 24
Secondary	Evaluation of Eczema Area and Severity Index (EASI)	To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)	Baseline, Week 12