Evaluation of ANB032 Efficacy and Safety in Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this Phase 2, randomized, double-blind, placebo-controlled study is to assess the **clinical efficacy** of ANB032 compared to placebo in subjects with moderate to severe **atopic dermatitis**. This evaluation is clinically relevant as it aims to determine the potential of ANB032 as a therapeutic option for managing symptoms and improving the quality of life in patients suffering from this chronic inflammatory skin condition. The study does not list any secondary objectives.

The clinical trial involves a total of **77 participants** diagnosed with **atopic dermatitis**. The study population comprises both male and female subjects, aged between 18 to 65 years, who are in good general health. Participants have been experiencing moderate to severe atopic dermatitis continuously for at least six months prior to randomization. The trial includes individuals with a history of inadequate response to both topical corticosteroids and topical calcineurin inhibitors, or for whom topical treatments are otherwise medically inadvisable. Key clinical assessments include an EASI score of 16 or higher and a vIGA-AD score of 3 or higher at both screening and randomization, with atopic dermatitis involving at least 10% of the body surface area. The selection process ensures a representative sample of the target population, with consideration given to the severity and chronicity of the condition. Lifestyle factors such as diet and physical activity are not specified, and the trial does not focus on any particular habits. The study does not include any specific vulnerable populations.

The clinical trial is a **randomized**, **double-blind**, placebo-controlled study designed to evaluate the efficacy and safety of ANB032 in the treatment of subjects with moderate to severe **atopic dermatitis**. The trial is structured to include a series of study visits over a period of approximately 14 weeks, with the primary endpoint being the proportion of subjects achieving a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 14. The trial is expected to commence recruitment on March 1, 2024, and conclude by May 31, 2025.

Participants will undergo an initial screening visit to confirm eligibility based on criteria such as age, health status, and severity of atopic dermatitis. Eligible participants will be randomly assigned to receive either ANB032, a placebo solution for injection, or auxiliary treatments such as **betamethasone dipropionate** or **hydrocortisone** for cutaneous use. The maximum treatment period for ANB032 is 12 weeks, while auxiliary treatments are limited to 7 days. The study will involve regular follow-up visits to monitor the participants' response to treatment and any adverse effects.

The expected length of participant involvement is approximately 14 weeks, including the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The end-of-study visit will assess the final outcomes and collect data for analysis. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of **ANB032**, a biological investigational product, formulated as a **solution for injection**. The active substance, ANB032, is a protein-based compound developed by ANAPTYSBIO, INC. The maximum daily dose is 400 mg, with a total maximum dose of 2400 mg over a treatment period of up to 12 weeks. The route of administration is via **subcutaneous injection**. Participant compliance will be monitored through regular assessments and documentation of dosing schedules.

In addition to the experimental treatment, the study includes the use of a **placebo solution for injection**. The placebo is designed to match the experimental product in appearance and administration method, ensuring the study remains double-blind. The placebo is administered subcutaneously, following the same dosing schedule as the experimental treatment, to maintain consistency across the study groups.

Two auxiliary treatments are also utilized in the study. **Betamethasone dipropionate** is provided in a pharmaceutical form identified as PHF00017MIG, intended for **cutaneous use**. The maximum daily dose is 1 mg, with a total maximum dose of 7 mg over a 7-day treatment period. This chemical compound is used to manage symptoms and is not the primary focus of the study.

Similarly, **hydrocortisone**, another auxiliary treatment, is administered in a form identified as PHF00099MIG, also for cutaneous use. The maximum daily dose is 50 mg, with a total maximum dose of 350 mg over a 7-day period. This chemical compound serves as a supportive treatment to manage symptoms associated with the condition under investigation.

The efficacy of ANB032 in the treatment of moderate to severe **atopic dermatitis** will be assessed through a Phase 2, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the proportion of subjects achieving a ≥ 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75) at Week 14. This endpoint is designed to measure significant improvement in the severity and extent of atopic dermatitis symptoms.

Participants will be evaluated using the EASI score, a validated scale that quantifies the severity of eczema based on the extent of body surface area affected and the intensity of inflammation. The EASI score will be collected at baseline and at Week 14 to determine the percentage reduction. Additionally, the trial will include assessments of the vIGA-AD score and the percentage of body surface area (BSA) involved, both at screening and randomization, to ensure consistent and reliable measurement of disease severity and treatment response.