A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

The primary objective of this study is to evaluate the effect of different dose regimens of IMG-007, compared to placebo, on disease activity, as measured by Eczema Area and Severity Index (EASI) in participants with moderate to severe atopic dermatitis, at the end of the placebo-controlled treatment period. This assessment is clinically relevant for determining the optimal dosing strategy and therapeutic efficacy of IMG-007 in reducing disease burden in patients with moderate to severe atopic dermatitis.

The secondary objectives include:

• To evaluate the effect of different dose regimens of IMG-007, compared to placebo, on disease activity, as measured by EASI and Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) in atopic dermatitis participants, during the placebo-controlled treatment period

• To evaluate the safety profile of different regimens of IMG-007 in atopic dermatitis participants

The clinical trial enrolled a total of **88 participants** diagnosed with **atopic dermatitis**. The study population included both **male** and **female** participants aged **18 to 74 years**. All participants had a confirmed diagnosis of atopic dermatitis according to the American Academy of Dermatology Consensus diagnostic criteria, with the condition present for at least one year prior to enrollment. The trial specifically recruited individuals with **moderate-to-severe** active disease who had documented inadequate response to or lack of tolerability of topical treatments, including **topical corticosteroids** and **topical calcineurin inhibitors**, or for whom such treatments were inadvisable. Participants were required to maintain a stable regimen of non-medicated **emollient** use throughout the study. Female participants of childbearing potential and male participants were required to use highly effective methods of **contraception**, while pregnant or breastfeeding women were excluded from participation. The selection criteria ensured enrollment of patients with significant disease burden requiring systemic therapeutic intervention beyond conventional topical management.

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding clinical trial designed to evaluate the efficacy and safety of IMG-007 in adult participants with moderate-to-severe atopic dermatitis. The study investigates different dose regimens of IMG-007, administered as a solution for injection via subcutaneous injection, compared to placebo. The active substance IMG-007 is a protein-based investigational medicinal product. The trial employs a parallel-group design where participants are allocated to receive either the test product or placebo throughout the treatment period.

The primary objective is to evaluate the effect of different dose regimens of IMG-007 on disease activity, as measured by the Eczema Area and Severity Index (EASI), at the end of the placebo-controlled treatment period. The primary endpoint is defined as the mean percent change from baseline in EASI at Week 20. Secondary endpoints include mean percent change from baseline in EASI at Week 16, the proportion of participants achieving at least 75% reduction in EASI (EASI-75) at Week 16 and Week 20, the proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 and Week 20, and the incidence and severity of treatment-emergent adverse events including treatment-emergent serious adverse events.

Eligible participants include male or female individuals aged 18 years or older and younger than 75 years with a diagnosis of atopic dermatitis that has been present for at least 1 year before the screening visit. Participants must have active moderate-to-severe atopic dermatitis and documented history of inadequate response to or lack of tolerability of a stable regimen of one or more topical treatments, such as topical corticosteroids or topical calcineurin inhibitors, or for whom topical treatments are otherwise inadvisable. Participants must agree to apply a stable dose of a non-medicated emollient (moisturizer). Female participants must not be pregnant or breastfeeding and must either not be of childbearing potential or agree to use a highly effective method of contraception. Male participants must also agree to use a highly effective method of contraception or must be surgically sterilized.

The maximum treatment period for IMG-007 is 52 weeks. The estimated recruitment start date is September 30, 2025, with an estimated study end date of October 15, 2027. Participant involvement includes a screening visit to assess eligibility according to the inclusion and exclusion criteria, followed by regular follow-up visits throughout the treatment period to monitor efficacy and safety parameters. Key assessment visits occur at Week 16 and Week 20 for evaluation of primary and secondary endpoints. An end-of-study visit is conducted to complete final assessments and ensure participant safety. Conditions that may lead to early termination from the study include the occurrence of serious adverse events, participant withdrawal of consent, investigator decision based on safety concerns, or failure to comply with study procedures and restrictions.

The experimental medication **IMG-007** is administered as a **solution for injection** via **subcutaneous injection**. IMG-007 is a protein-based investigational medicinal product with the sponsor product code IMG-007, manufactured by INMAGENE LLC. The active substance is classified as a protein of other origin. The maximum treatment period for IMG-007 administration is **52 weeks**. Different dose regimens of IMG-007 are evaluated in this study to assess efficacy and safety in participants with **moderate-to-severe atopic dermatitis**.

A **placebo** is utilized as the comparator treatment in this **double-blinded, placebo-controlled** clinical trial. The placebo serves as the control arm against which the efficacy and safety of IMG-007 are compared during the placebo-controlled treatment period. The study employs a **parallel-group design** to evaluate the effect of different dose regimens of the experimental medication compared to placebo on disease activity, as measured by the **Eczema Area and Severity Index (EASI)**.

Efficacy will be assessed using the Eczema Area and Severity Index (EASI) as the primary measure of disease activity in participants with moderate-to-severe atopic dermatitis. The primary endpoint is the mean percent change from baseline in EASI at Week 20. Secondary efficacy endpoints include the mean percent change from baseline in EASI at Week 16, the proportion of participants achieving at least a 75% reduction in EASI (EASI-75) at Week 16 and Week 20, and the proportion of participants achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 and Week 20. These assessments will be conducted at specified timepoints during the placebo-controlled treatment period to evaluate the effect of different dose regimens of IMG-007 compared to placebo on disease activity.