Long-Term Safety and Efficacy Assessment of Nemolizumab (CD14152) in Prurigo Nodularis Patients

The primary objective of this study is to assess the long-term **safety** of nemolizumab (CD14152) in subjects with **Prurigo Nodularis** (PN). Evaluating the safety profile of nemolizumab is clinically relevant as it ensures the therapeutic agent can be used over extended periods without causing adverse effects, which is crucial for managing chronic conditions like PN.

The secondary objective is to assess the long-term efficacy of nemolizumab (CD14152) in subjects with PN. This evaluation is important to determine the sustained therapeutic benefits of the treatment, ensuring that it not only remains safe but also effective in alleviating the symptoms associated with PN over time.

The clinical trial involves a total of **160 participants** diagnosed with **Prurigo Nodularis**, a chronic skin condition. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected based on their previous involvement in nemolizumab studies for Prurigo Nodularis, ensuring they meet specific inclusion criteria. The trial does not focus on a vulnerable population, and participants are expected to maintain their usual lifestyle, with no specific dietary or physical activity requirements outlined. The study aims to assess the long-term safety of nemolizumab in this population.

The clinical trial is designed to evaluate the long-term safety and efficacy of **nemolizumab** in subjects with **prurigo nodularis**. This is a prospective, multicenter study with a randomized, double-blind, and controlled design. The trial is expected to span from October 26, 2020, to August 15, 2027, with a maximum treatment period of 180 days for each participant. The study involves multiple visits, starting with an inclusion (screening) visit to assess eligibility based on specific criteria, including prior participation in related studies and compliance with contraceptive measures for female participants of childbearing potential.

Participants will undergo regular follow-up visits to monitor the incidence and severity of adverse events, as well as to evaluate secondary endpoints such as the proportion of subjects achieving Investigator Global Assessment (IGA) success and improvements in pruritus and quality of life measures. These visits will occur periodically up to Week 184, with specific assessments for those re-entering from a previous durability study. The end-of-study visit will conclude the participant's involvement, ensuring all safety and efficacy data are collected.

Participant involvement is expected to last up to the full duration of the trial, contingent upon adherence to the study protocol. Conditions that may lead to early termination include non-compliance with study procedures, withdrawal of consent, or the occurrence of significant adverse events. The trial aims to provide comprehensive data on the long-term use of **nemolizumab** for **prurigo nodularis**, contributing valuable insights into its safety profile and therapeutic potential.

The clinical trial involves the administration of **Nemolizumab**, a **biological** agent, as the experimental medication. Nemolizumab is provided in the form of a **solution for injection** and is intended for **subcutaneous use**. The active substance, **nemolizumab**, is a protein of other origin, specifically designed for the treatment of **prurigo nodularis**. The pharmaceutical form is a solution for injection, and the medication is manufactured by Galderma S.A. The maximum daily dose of Nemolizumab is 60 mg, with a total maximum dose of 2760 mg over the course of the treatment period, which spans up to 180 days. The dosing schedule and administration frequency are determined by the study protocol, ensuring adherence to the specified maximum dosage limits.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on assessing the long-term safety and efficacy of Nemolizumab in subjects with prurigo nodularis. Participant compliance with the dosing regimen is monitored throughout the trial to ensure accurate assessment of the medication's safety profile. The trial is designed to provide comprehensive data on the safety and therapeutic potential of Nemolizumab in the target patient population.

The efficacy of Nemolizumab in the treatment of **Prurigo Nodularis** will be assessed through a series of primary and secondary endpoints. The primary efficacy endpoint focuses on the incidence and severity of adverse events, including treatment-emergent adverse events and serious adverse events. Secondary efficacy endpoints include a variety of measures to evaluate clinical outcomes over time. These include the proportion of subjects achieving an Investigator Global Assessment (IGA) success, defined as an IGA score of 0 (Clear) or 1 (Almost clear), at each visit up to Week 184. Additionally, the study will assess the proportion of subjects with an improvement of ≥4 from baseline in the Peak Pruritus Numeric Rating Scale (PP NRS) and the proportion of subjects with low disease activity state (IGA ≤2) at each visit up to Week 184.

Other secondary endpoints include the percentage of pruriginous lesions with excoriations/crusts and the percentage of healed prurigo lesions at each visit up to Week 184. Changes from baseline in the number of lesions in a representative area, as well as absolute and percent changes in PP NRS, will also be evaluated. The study will further assess the proportion of subjects with an improvement of ≥4 from baseline in the Sleep Disturbance Numeric Rating Scale (SD NRS) and the Dermatology Life Quality Index (DLQI) up to Week 184. Patient-reported outcomes, such as the Patient Global Assessment of Disease (PGAD) and the Patient Global Assessment of Treatment (PGAT), will be collected to evaluate patient satisfaction and perceived treatment efficacy. The time to permanent study drug discontinuation and the time to rescue therapy use will also be recorded.