NCT03338998

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).

A Phase II, Patient- and Investigator-blinded, Randomized, Placebo-controlled Study to Evaluate Efficacy, Safety and Tolerability of BAF312 (Siponimod) in Patients With Stroke Due to Intracerebral Hemorrhage (ICH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)

Detailed description

This was the first trial of BAF312 in ICH patients to evaluate if BAF312 had the potential to limit brain inflammation after ICH, and thereby improve neurological outcome for stroke patients when administered in addition to standard of care. ICH patients meeting study criteria were randomized at 1:1 ratio into either active or placebo group. Patients received an intravenous infusion (i.v.) treatment within 24 hours of an ICH event and were up titrated for 7 days. Following the i.v. treatment, participants received 10 mg BAF312 or placebo in tablet form (taken daily orally) for an additional 7 days. Participants were followed for an additional 76 days after treatment for neurological and safety conditions during three clinic visits. Recruitment for the trial was put on hold due to the COVID-19 pandemic. Thirty-two patients had been enrolled in the trial and completed the protocol as planned. After seven months of the trial being on hold, an Interim analysis was conducted and reviewed by the Data Monitoring Committee. Novartis terminated the trial due to lack of potential efficacy.

Conditions

• Hemorrhagic Stroke
• Intracerebral Hemorrhage (ICH)

Interventions

Type	Name	Description
DRUG	BAF312 solution	Solution for intravenous (IV) infusion - 4.5mg/4.5mL
DRUG	Matching Placebo for BAF312 solution	Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo
DRUG	BAF312 tablet	2 mg film-coated tablet
DRUG	Matching Placebo for BAF312 tablet	0 mg film-coated tablet matching placebo

Timeline

• Start date: 2017-12-24
• Primary completion: 2020-05-13
• Completion: 2020-05-13
• First posted: 2017-11-09
• Last updated: 2022-08-12
• Results posted: 2021-06-07

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study