drugset / Trial / NCT05468073

Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

NCT05468073

RandomizedParallel-groupDouble-blindTreatment

Summary

Study aims at evaluating the therapeutic efficacy and safety of low-dose IL-2 immunomodulatory treatment in patients with early AD, in a phase II, randomized, double blind, placebo-controlled phase II clinical trial. Patients with AD at early stage will be recruited and randomized (2:1) in each treatment group. The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.

Timeline

Start
2022-10-11
Primary completion
2025-09-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 1e+06 iu Subcutaneous

Indications