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

Not yet recruiting

Phase 2 Results N/A

Trial Description

This is a randomized, placebo-controlled, subject- and investigator-blinded trial of BAF312 in intracerebral hemorrhage (ICH) patients to study efficacy, safety, and tolerability. BAF312 is a drug that could potentially limit brain inflammation after ICH, and thereby improve neurological outcome for hemorrhagic stroke patients.
In this study, ICH patients meeting study criteria will be randomized at 1:1 ratio into either active or placebo group. The first i.v. treatment must starts within 24 hours of ICH event. Participating patients will also be followed up for additional 76 days after treatment on neurological and safety conditions in 3 clinic visits.
BAF312 treatment includes the following identified risks: transient effects on heart rate and rhythm (bradyarrhythmia and 2nd degree AV block) at treatment initiation that are completely avoided by initial up-titration; liver enzyme elevation; lymphopenia due to lymphocyte redistribution (expected effect of BAF312); macular edema; and varicella zoster (VZV) infection.

Detailed Description

This is the first trial of BAF312 in ICH patients to study efficacy, safety, and tolerability, compared to placebo. BAF312 is a drug that could potentially limit brain inflammation after ICH, and thereby improve neurological outcome for stroke patients.
In this study, ICH patients meeting study criteria will be randomized at 1:1 ratio into either active or placebo group. The first i.v. treatment must starts within 24 hours of ICH event. Participating patients will also be followed up for additional 76 days after treatment on neurological and safety conditions in 3 clinic visits.
BAF312 treatment includes the following identified risks: transient effects on heart rate and rhythm (bradyarrhythmia and 2nd degree AV block) at treatment initiation that are completely avoided by initial up-titration; liver enzyme elevation; lymphopenia due to lymphocyte redistribution (expected effect of BAF312); macular edema; and varicella zoster (VZV) infection.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Supplied as an i.v. solution for days 1 through 7 and as tablets for days 8 through 14
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Days 1 through 7: i.v. matching placebo Days 8 through 14: p.o. matching placebo QD
  • BAF312 Drug
    Intervention Desc: Supplied as an i.v. solution for days 1 through 7 and as a tablet for days 8 through 14
    ARM 1: Kind: Experimental
    Label: BAF312
    Description: Days 1 - 7, IV uptitration; days 8 - 14, final daily dose administered orally"

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale (mRS) score Day 90
Secondary Plasma BAF312 concentrations Days 1, 8, and 14

Sponsors