A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis

The primary objective of this study is to assess the efficacy of GIA632 compared to placebo at Week 16 in adult participants with moderate to severe atopic dermatitis. This evaluation is clinically relevant as it determines whether GIA632 demonstrates therapeutic benefit in reducing disease severity and improving clinical outcomes in patients with this chronic inflammatory skin condition who have not achieved adequate control with existing treatments.

The secondary objective is to assess the safety and tolerability of GIA632, which is essential for establishing the overall benefit-risk profile of this investigational biologic agent in the target patient population.

This clinical trial enrolled a total of **35 participants** diagnosed with **atopic dermatitis**. The study population included both **male and female subjects** aged **18 years and older**. Participants were required to have a confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria, with disease onset at least one year prior to the screening visit. The trial specifically recruited individuals with **moderate to severe atopic dermatitis**, as defined by an Investigator's Global Assessment score of 3 or higher at both screening and baseline visits. The selection process focused on adults presenting with chronic atopic dermatitis of sufficient severity to warrant therapeutic intervention with the investigational product GIA632.

This is a multicenter, randomized, participant- and investigator-blinded, placebo-controlled, phase 2a clinical trial designed to evaluate the efficacy, safety, and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis. The study compares GIA632, administered as a solution for injection via subcutaneous injection, against placebo. GIA632 is an orphan drug designated under EU/3/16/1681, containing a protein-based active substance. The trial employs a blinded design whereby both participants and investigators remain unaware of treatment allocation throughout the study period.

The primary objective is to assess the efficacy of GIA632 compared to placebo at Week 16. The primary endpoint is defined as IGA response at Week 16, characterized by a clear (0) or almost clear (1) score with at least a 2-point reduction from baseline. Secondary endpoints include the evaluation of treatment-emergent adverse events (TEAEs) until the end of study. The maximum treatment period is 16 weeks, with the overall trial duration extending from the estimated recruitment start date in February 2026 to the estimated end date in August 2027.

Eligible participants must meet specific inclusion criteria at the screening visit. Males and females aged 18 years or older at the time of the initial screening visit are eligible for enrollment. Participants must have a diagnosis of atopic dermatitis according to the Hanifin and Rajka (1980) criteria, with disease onset at least 1 year prior to the screening visit. At both the screening and baseline visits, participants must demonstrate moderate to severe atopic dermatitis, defined by an IGA score of 3 or greater, with baseline assessments performed on Day 1 prior to treatment initiation.

The study involves a series of structured visits beginning with the screening visit for participant eligibility assessment. Following successful screening, participants undergo randomization and receive their first dose of study medication at the baseline visit. Subsequent follow-up visits are scheduled throughout the 16-week treatment period to monitor efficacy parameters and safety outcomes. The end-of-study visit occurs after completion of the 16-week treatment period or upon early termination. Participant involvement spans the duration of the treatment period plus any additional follow-up required for safety monitoring. Conditions that may lead to early termination from the study include the occurrence of unacceptable adverse events, participant withdrawal of consent, protocol violations, or investigator decision based on safety or medical considerations.

The experimental medication **GIA632** is administered as a **solution for injection** in a concentration of 150 mg/mL. The active substance GIA632, also known by the synonym CALY-002, is classified as a protein of other origin. The product is manufactured by Novartis Pharma AG and has been designated as an **orphan drug** under the designation number EU/3/16/1681. GIA632 is administered via **subcutaneous injection**. The maximum treatment period is 16 weeks.

The **placebo** comparator is formulated to match GIA632 150 mg/mL solution for injection. The placebo is administered to maintain blinding in this participant- and investigator-blinded study design. The placebo serves as the control treatment against which the efficacy, safety, and tolerability of the experimental medication are assessed.

The efficacy of GIA632 compared to placebo will be assessed at Week 16 in participants with moderate to severe atopic dermatitis. The primary endpoint is IGA response at Week 16, defined as achieving a clear (0) or almost clear (1) score with at least a 2-point reduction from baseline. Baseline assessments include an IGA score of 3 or greater, which must be present at both the screening and baseline visit prior to treatment initiation. The treatment period extends for 16 weeks, during which efficacy parameters will be evaluated to determine the therapeutic benefit of GIA632 in this patient population.