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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05984784
Other study ID # IMG-007-201
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date August 9, 2023
Est. completion date April 26, 2024

Study information

Verified date May 2024
Source Inmagene LLC
Contact n/a
Is FDA regulated No
Health authority
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 Terminated
Enrollment 13
Est. completion date April 26, 2024
Est. primary completion date April 26, 2024
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.

Study Design


Related Conditions & MeSH terms


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
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