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

Sponsor

Inmagene LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05984784

Collaborator

(none)

Enrollment

Locations

Arms

8.7

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Moderate-to-severe Atopic Dermatitis AD	Drug: IMG-007	Phase 1/Phase 2

Detailed Description

This is a phase 1b/2a, double-arm, open-label 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 three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 9, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMG-007 300mg 300mg of IMG-007 will be administered intravenously 3 times over 4 weeks	Drug: IMG-007 Drug: IMG-007 Intravenous Infusion
Experimental: IMG-007 600mg 600mg of IMG-007 will be administered intravenously 3 times over 4 weeks	Drug: IMG-007 Drug: IMG-007 Intravenous Infusion

Arm

Intervention/Treatment

Experimental: IMG-007 300mg

300mg of IMG-007 will be administered intravenously 3 times over 4 weeks

Drug: IMG-007

Drug: IMG-007 Intravenous Infusion

Experimental: IMG-007 600mg

600mg of IMG-007 will be administered intravenously 3 times over 4 weeks

Drug: IMG-007

Drug: IMG-007 Intravenous Infusion

Outcome Measures

Primary Outcome Measures

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

Pharmacokinetic Characterization [Baseline, Week 24]
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Center of Miami II Inc	Miami	Florida	United States	33134
2	Revival Research Institute, LLC	Troy	Michigan	United States	48084
3	Central Sooner Research	Oklahoma City	Oklahoma	United States	73170
4	Paddington Testing Co, Inc	Philadelphia	Pennsylvania	United States	19103