P2-IMU-838-PMS - Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis (Calliper)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514617-35-00

Acronym

P2-IMU-838-PMS

Enrollment

230

Registered

2024-09-12

Start date

2021-12-20

Completion date

Unknown

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive forms of Multiple Sclerosis

Brief summary

Annualized rate of percent brain volume change (PBVC) during MT period.

Detailed description

Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period

Interventions

DRUGIMU-838 22.5 mg tablet

DRUGIMU-838 45 mg tablet

DRUGPlacebo for IMU-838 Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Annualized rate of percent brain volume change (PBVC) during MT period.	—

Secondary

Measure	Time frame
Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period	—

Countries

Bulgaria, Czechia, Germany, Netherlands, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026