Efficacy and Safety of ANB032 with Hydrocortisone/Alclometasone Dipropionate in Patients with Moderate to Severe Atopic Dermatitis: Randomized Phase 2 Study

The primary objective of this 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 is designed as a Phase 2, randomized, double-blind, placebo-controlled trial, ensuring rigorous assessment of the treatment's efficacy and safety.

The clinical trial involves a total of **100 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 selected based on their history of moderate to severe atopic dermatitis persisting for at least six months prior to randomization. The trial includes individuals who have shown an inadequate response to topical treatments or for whom such treatments are medically inadvisable. Key lifestyle considerations such as diet and physical activity are not specified. The trial population was carefully chosen to ensure that participants have an EASI score of 16 or higher and a vIGA-AD score of 3 or higher at both screening and randomization, with at least 10% of their body surface area affected by atopic dermatitis. The study does not specify any particular lifestyle habits or conditions beyond the medical criteria outlined.

The clinical trial is a **Phase 2**, 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 aims to assess the clinical efficacy of ANB032 compared to a placebo, with the primary endpoint being the mean change from baseline in the Eczema Area and Severity Index (EASI) at Week 14. The trial is expected to run from September 1, 2023, to November 30, 2024, with participant involvement lasting approximately 14 weeks.

Participants will be randomly assigned to receive either ANB032, administered as a subcutaneous injection, or a placebo. The study includes several key visits: an initial screening visit to confirm eligibility, followed by regular follow-up visits to monitor safety and efficacy, and an end-of-study visit to assess final outcomes. Inclusion criteria require participants to be aged 18 to 65 years, in good general health, and have moderate to severe atopic dermatitis for at least six months prior to randomization. Participants must also have a history of inadequate response to topical treatments or for whom such treatments are medically inadvisable. Key exclusion criteria are not specified in the provided data.

Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial will utilize a placebo matching investigational medicinal product (IMP) to ensure blinding. The study's design and procedures are structured to maintain scientific rigor and ensure the collection of reliable data on the efficacy and safety of ANB032 in treating atopic dermatitis.

The clinical trial involves the evaluation of **ANB032**, a biological investigational medicinal product, formulated as a solution for injection. ANB032 is administered via subcutaneous injection. The dosing regimen includes a maximum daily dose of 400 mg, with a total maximum dose of 2400 mg over a treatment period of up to 12 weeks. The investigational product is developed by ANAPTYSBIO, INC. and is intended to assess its efficacy and safety in subjects with moderate to severe atopic dermatitis.

A **placebo** matching the investigational medicinal product is utilized in this study to maintain the double-blind design. The placebo is administered in the same pharmaceutical form and route as ANB032, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thus minimizing bias in the assessment of the investigational product's efficacy and safety.

**Hydrocortisone**, a chemical auxiliary treatment, is included in the study protocol. It is administered via cutaneous use, with a maximum daily dose of 50 mg and a total maximum dose of 350 mg over a 7-day treatment period. Hydrocortisone serves as a standard-of-care therapy to manage symptoms of atopic dermatitis in the study population.

**Alclometasone dipropionate** is another chemical auxiliary treatment used in the trial. It is also administered cutaneously, with a maximum daily dose of 1 mg and a total maximum dose of 7 mg over a 7-day treatment period. Alclometasone dipropionate is employed to provide additional therapeutic support for managing atopic dermatitis symptoms in the study participants.

The efficacy of ANB032 in the treatment of moderate to severe **atopic dermatitis** will be assessed in a Phase 2, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the mean change from baseline in the Eczema Area and Severity Index (EASI) at Week 14. This endpoint will be measured using the EASI, a validated scale that quantifies the severity and extent of eczema. The EASI score will be collected at baseline and at Week 14 to determine the change in severity of the condition.