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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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AD, Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis

Intervention / Treatment
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* Drug: Placebo
* Drug: IMG-007


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMG-007 Dose 1<br>IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks | Drug: IMG-007<br>* Drug: IMG-007 Intravenous Infusion<br>|
| Experimental: IMG-007 Dose 2<br>IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks | Drug: IMG-007<br>* Drug: IMG-007 Intravenous Infusion<br>|
| Placebo Comparator: Placebo<br>Placebo will be administered intravenously 3 times over 4 weeks | Drug: Placebo<br>* Drug: Placebo Intravenous Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents, IMG-007