NCT05054140

Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Immunic AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

Detailed description

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods: Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	IMU-838	IMU-838 tablets
DRUG	Placebo matching IMU-838	Placebo matching IMU-838 tablets

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2021-09-23
• Last updated: 2024-04-29

Locations

73 sites across 12 countries: United States, Bulgaria, Canada, Czechia, Germany, Moldova, Netherlands, North Macedonia, Poland, Romania, Serbia, Ukraine

Regulatory

• FDA-regulated drug study