Evaluation of Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults with Moderate-to-Severe Atopic Dermatitis

The primary objective of this study is to evaluate **adverse events (AEs)** emergent of IMG-007 in adult participants with **atopic dermatitis (AD)**. This is clinically relevant as it assesses the safety profile of IMG-007, which is crucial for determining its suitability for further development and potential therapeutic use in managing moderate-to-severe atopic dermatitis.

Secondary objectives include:

• Characterizing the **pharmacokinetic (PK) profile** of IMG-007 in AD participants, which is essential for understanding the drug's absorption, distribution, metabolism, and excretion.
• Evaluating the **efficacy** of IMG-007 in AD participants as measured by the **eczema area and severity index (EASI)** at Week 12, providing insights into the therapeutic potential of IMG-007 in reducing the severity and extent of eczema.

The clinical trial involves a total of **15 participants** diagnosed with **atopic dermatitis**. The study population includes both male and female adults aged between 18 and 74 years. Participants were selected based on their diagnosis of moderate-to-severe atopic dermatitis, as defined by specific clinical criteria, and a documented history of inadequate response or intolerance to topical treatments. All participants are required to apply a stable dose of a non-medicated emollient. The trial includes individuals who are not pregnant or breastfeeding, and those who agree to use effective contraception methods. The study population is characterized by a vulnerable group, as it includes individuals with a chronic dermatological condition. The selection criteria ensure that participants have a consistent health status relevant to the study's objectives.

The clinical trial is designed to evaluate the **safety**, pharmacokinetics, and efficacy of IMG-007 in adult participants with moderate-to-severe **atopic dermatitis**. This study is a Phase 1b/2a, single-arm trial, which will assess multiple doses of IMG-007. The trial is not categorized as low intervention and is expected to start recruitment on April 2, 2024, with an estimated end date of December 31, 2024. Participants will be involved in the study for a duration that aligns with the trial's timeline, with specific visits scheduled throughout the study period.

The trial will include a screening visit to confirm eligibility based on criteria such as age, diagnosis of atopic dermatitis, and severity of the condition. Participants must have a documented history of inadequate response or intolerance to topical treatments. The study will involve the administration of IMG-007 via **intravenous** infusion, with a placebo group receiving a formulation identical to the drug product minus the active ingredient. The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs), while secondary endpoints include pharmacokinetic parameters and the percentage change in the Eczema Area and Severity Index (EASI) from baseline to week 12.

Study visits will be structured to monitor the safety and efficacy of the treatment, with follow-up visits scheduled to assess the participants' response to the treatment and any adverse events. The end-of-study visit will conclude the participants' involvement, ensuring all necessary data is collected and any remaining health concerns are addressed. Participants may be withdrawn from the study early if they experience significant adverse events or if they do not comply with the study protocol. The trial aims to provide valuable insights into the treatment of moderate-to-severe atopic dermatitis with IMG-007, contributing to the understanding of its safety and efficacy profile.

The clinical trial involves the administration of **IMG-007**, an experimental medication formulated as a **solution for infusion**. The active substance, also named IMG-007, is a protein of other origin. The medication is administered **intravenously**. The frequency and dosage of administration are determined based on the study protocol, which aims to evaluate the safety, pharmacokinetics, and efficacy of IMG-007 in adult participants with moderate-to-severe atopic dermatitis. Participant compliance is monitored through regular assessments and documentation of infusion sessions.

In addition to the experimental medication, the study includes the use of an **IMG-007 placebo**, which is identical in formulation to the drug product but lacks the active ingredient. The placebo is used to maintain blinding and assess the efficacy of the experimental treatment. The pharmaceutical form and route of administration for the placebo are consistent with those of the active drug, ensuring that participants and investigators remain unaware of the treatment allocation.

Several auxiliary treatments are also part of the study protocol. These include chemical entities categorized under various **ATC codes**: D02A (emollients and protectives), H02A (corticosteroids for systemic use, plain), L04A (immunosuppressants), D11AH (agents for dermatitis, excluding corticosteroids), and D07A (corticosteroids, plain). These auxiliary treatments are administered either topically or orally, depending on their specific formulation and intended use. The dosing schedules for these treatments are outlined in the study protocol, and participant adherence is monitored through regular follow-ups and documentation.

The efficacy of IMG-007 in the treatment of moderate-to-severe **Atopic Dermatitis** will be assessed through a series of predefined endpoints. The primary endpoint for evaluating efficacy is the incidence of treatment-emergent adverse events (TEAEs). Secondary endpoints include pharmacokinetic (PK) parameters as data permit and the percentage change in the Eczema Area and Severity Index (EASI) from baseline to week 12. These endpoints will provide a comprehensive evaluation of the drug's impact on the condition.

Data collection will occur at specific timepoints, including baseline and week 12, to ensure accurate measurement of changes in disease severity. The EASI score, a validated scale, will be used to quantify the severity of atopic dermatitis, allowing for a standardized assessment of symptom improvement. The analysis of these parameters will be conducted using appropriate statistical methods to determine the efficacy of IMG-007 in the study population.