drugset / Trial / NCT05052983

A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis

NCT05052983

Phase 3 Completed 34 enrolled Galderma R&D
RandomizedParallel-groupDouble-blindTreatment

Summary

The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.

Timeline

Start
2022-01-24
Primary completion
2023-09-11
Completion
2023-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Nemolizumab Monoclonal antibody 30 mg Subcutaneous
Subject Nemolizumab Monoclonal antibody 60 mg Subcutaneous

Indications