Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

Summary

Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).

Timeline

Start

2019-03-11

Primary completion

2022-12-28

Completion

2023-08-24

Outcome

Met primary endpoint

registry p = 0.0347; LS Mean Difference -21.2 (95% CI -40.82 to -1.60) NCT03816891 ↗

registry p <0.0001; LS Mean Difference -41.7 (95% CI -54.9 to -28.5) NCT03816891 ↗

paper Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses PMID 41405882 ↗

release “Phase 2 trial of vixarelimab in prurigo nodularis met primary efficacy endpoint: statistically significant reduction of weekly average WI-NRS at Week 8” kiniksa.com ↗

Publications

• Stander S, Yosipovitch G, Sofen H, Abramzon D, Galanter J, Wang S, Paolini JF. Vixarelimab in Patients With Prurigo Nodularis: A Randomized Clinical Trial. JAMA Dermatol. 2026 Feb 1;162(2):133-141. doi: 10.1001/jamadermatol.2025.4950.
• Ma DX, Neerumalla S, Baird A, Whitehead RA, Filip P, Tajudeen BA, Batra PS, Papagiannopoulos P. Impact of Obesity on the Structured Histopathology of Chronic Rhinosinusitis Patients. Laryngoscope. 2026 Mar;136(3):1150-1157. doi: 10.1002/lary.70177. Epub 2025 Oct 6.
• Sofen H, Bissonnette R, Yosipovitch G, Silverberg JI, Tyring S, Loo WJ, Zook M, Lee M, Zou L, Jiang GL, Paolini JF. Efficacy and safety of vixarelimab, a human monoclonal oncostatin M receptor beta antibody, in moderate-to-severe prurigo nodularis: a randomised, double-blind, placebo-controlled, phase 2a study. EClinicalMedicine. 2023 Feb 3;57:101826. doi: 10.1016/j.eclinm.2023.101826. eCollection 2023 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vixarelimab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Vixarelimab	Monoclonal antibody	360 mg	Subcutaneous
Subject	Vixarelimab	Monoclonal antibody	540 mg	Subcutaneous

Indications