drugset / Trial / NCT04501679
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.
Timeline
- Start
- 2020-08-11
- Primary completion
- 2022-03-30
- Completion
- 2022-03-31
Outcome
Met primary endpoint
registry analysis (superiority test); Nemolizumab vs Placebo; p <0.0001; Strata-adjusted percentage difference 37.4 (95% CI 26.3 to 48.5) NCT04501679 ↗
registry analysis (superiority test); Nemolizumab vs Placebo; p <0.0001; Strata-adjusted percentage difference 28.5 (95% CI 18.8 to 38.2) NCT04501679 ↗
Publications
- Results Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333.
- Stander S, Rodriguez DN, Dias-Barbosa C, Filipenko D, Puelles J, Jabbar-Lopez ZK, Piketty C, Wiegmann H, Kwatra SG. Content Validity and Psychometric Validation of an Adapted Version of the Subject Sleep Diary in Prurigo Nodularis. Dermatol Ther (Heidelb). 2025 Jun;15(6):1405-1426. doi: 10.1007/s13555-025-01406-1. Epub 2025 Apr 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemolizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Nemolizumab | Monoclonal antibody | 60 mg | Subcutaneous |