Randomized, Placebo‑Controlled Study of IMU‑838 on Cardiac Repolarization (QT/QTc) in Adults With Multiple Sclerosis

The trial enrolled individuals identified as healthy volunteers, including both Multiple sclerosis patients and participants without the disease, with representation of female and male subjects and inclusion of vulnerable populations; the sponsor did not provide the total number of participants or a specific age range, and selection was based on general health status without additional lifestyle requirements such as diet or physical activity, while key inclusion criteria encompassed eligibility as a healthy volunteer and the ability to provide informed consent, and exclusion criteria were limited to factors that would compromise safety or data integrity.

The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the effect of IMU‑838 on QT/QTc in participants with Multiple sclerosis. Recruitment is planned from 14 July 2026 to 7 September 2026, with each participant remaining in the study for the full trial period, encompassing a screening visit, a baseline/randomization visit, scheduled follow‑up visits at predetermined intervals, and a final end‑of‑study visit. The screening visit confirms eligibility criteria; the baseline visit assigns participants to IMU‑838 or matching placebo; subsequent visits assess safety, ECG parameters, and tolerability; the end‑of‑study visit concludes assessments and collects final data. Participants are expected to be involved for the duration of the protocol‑defined follow‑up, approximately eight weeks. Early termination may occur if a participant experiences a serious adverse event, violates key protocol requirements, or withdraws consent.

No experimental medication, comparator, or standard‑of‑care treatment details were provided in the source data; therefore a specific description of the study drugs, including name, pharmaceutical form, dosage, route, frequency, dosing schedule, or compliance monitoring procedures cannot be supplied.

Efficacy will be evaluated in accordance with the study protocol for participants with multiple sclerosis.