A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (aged 6 to 23 months) with Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled with Topical Therapy

Condition studied

Atopic Dermatitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

1.Observed nemolizumab serum concentrations at Week 4, Week 16, Week 32, and Week 52., 2.PopPK Predicted nemolizumab steady state PK parameters., 3.Incidence of adverse events (AEs), including treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), AEs leading to discontinuation and serious AEs (SAEs) through the study.

Endpoint detail

1.Absolute and percent change in EASI score from baseline at each visit up to Week 52., 2.Proportion of subjects with EASI-50, EASI-75 and EASI-90 (≥ 50%, ≥75% and ≥90% improvement in EASI from baseline) at each visit up to Week 52., 3.IGA success rate (defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥2-point improvement from baseline) at each visit up to Week 52. ", 4.Absolute and percent change in weekly average of peak pruritus Numeric Rating Scale (PP-NRS) score from baseline up to Week 52., 5.Proportion of subjects with an improvement of ≥4 from baseline in weekly average of PP-NRS up to Week 52, 6..Change in SCORAD total score and its components from baseline at each visit up to Week 52., 7.Change in Infants’ Dermatitis Quality of Life Index (IDQOL) from baseline up to Week 52., 8.Change in proxy completion of the Patient-Oriented Eczema Measure (POEM) from baseline up to Week 52, 9.Proportion of subjects receiving any rescue therapy by rescue treatment type (e.g., topical, systemic) at any visit during the treatment period., 10.Odsetek uczestników otrzymujących jakąkolwiek terapię ratunkową według rodzaju leczenia ratunkowego (np. miejscowe, ogólnoustrojowe) podczas jakiejkolwiek wizyty w trakcie okresu leczenia., 11.Anti-drug antibody (ADA) assessments including ADA potency (titer) and neutralizing antibody (NAb) at baseline, Week 16, Week 52, and unscheduled visits that are conducted for safety reasons if deemed necessary by the investigator.