Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

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

2020-09-11

Primary completion

2022-11-11

Completion

2023-02-21

Outcome

Met primary endpoint

registry analysis (superiority test); Nemolizumab vs Placebo; p < 0.0001; Strata adjusted percentage difference 40.1 (95% CI 29.4 to 50.8) NCT04501666 ↗

registry analysis (superiority test); Nemolizumab vs Placebo; p = 0.0025; Strata adjusted percentage difference 14.6 (95% CI 6.7 to 22.6) NCT04501666 ↗

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.
• Stander S, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Metz M, Tsianakas A, Pink A, Fage S, Micali G, Weisshaar E, Sundaram H, Metelitsa A, Augustin M, Wollenberg A, Homey B, Fargnoli MC, Sofen H, Korman NJ, Skov L, Chen X, Jabbar-Lopez ZK, Piketty C, Kwatra SG; OLYMPIA 1 Investigators. Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial. JAMA Dermatol. 2025 Feb 1;161(2):147-156. doi: 10.1001/jamadermatol.2024.4796.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nemolizumab	Monoclonal antibody	30 mg	Subcutaneous
Subject	Nemolizumab	Monoclonal antibody	60 mg	Subcutaneous

Indications