Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Summary

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.

Timeline

Start

2019-09-19

Primary completion

2022-05-17

Completion

2022-05-17

Publications

• Denton CP, Kowal-Bielecka O, Proudman SM, Olesinska M, Worm M, Del Papa N, Matucci-Cerinic M, Radewonuk J, Jochems J, Panaite A, Shebl A, Krupa A, Allanore Y, Hofmann JH, Gasior MJ. A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). 2025 Jun 1;64(6):3657-3666. doi: 10.1093/rheumatology/keaf066.

Drugs

Indications