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Abstract Details

An Open-label Study Evaluating the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Tanruprubart Single Dose in Participants From North America and Europe With Guillain-Barré Syndrome
Neuro Trauma and Critical Care
P3 - Poster Session 3 (5:00 PM-6:00 PM)
19-004
Characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety of tanruprubart 30 mg/kg in participants with Guillain-Barré syndrome (GBS) from North America and Europe.
GBS is a neuromuscular emergency driven by classical complement activation that, despite current treatments, leads to significant morbidity and mortality in previously healthy individuals. Tanruprubart, a monoclonal antibody targeting C1q, the initiating molecule of classical complement, has been studied in a Phase 3, randomized, double-blind, placebo-controlled study in patients with GBS in southeast Asia. Tanruprubart 30 mg/kg was well tolerated and participants were 2.4 times more likely to be in a better state of health (GBS-DS; p=0.0058) versus placebo at Week 8 with rapid improvement in muscle strength (MRCss) from Week 1.
GBS-FORWARD is a multicenter, open-label, single-arm study of single intravenous administration tanruprubart 30 mg/kg in US and European participants recently diagnosed with GBS. Participants must be 12–85 years old, have a GBS diagnosis per NINDS criteria, with onset of GBS-related weakness ≤10 days before infusion on Day 1. Participants will remain hospitalized from screening until assessment completion on Day 8 or until medically cleared for release, whichever occurs later. Participants will have follow-up visits through Week 26 and receive best supportive care, omitting intravenous immunoglobulin or plasma exchange unless as a rescue treatment.
Approximately 30 participants are planned for enrollment. The primary objective is to characterize the pharmacokinetics of a single tanruprubart dose, which will enable comparison with pharmacokinetic data obtained from previous studies in participants from Southeast Asia. The study is powered to compare MRC sumscore at Week 1 with an IVIg-treated, external control group from the International GBS Outcome Study database.
This study will add to the extensive body of evidence showing the benefit of tanruprubart in patients with GBS and confirm previous study findings in a population from North America and Europe.
Authors/Disclosures
Shafeeq Ladha, MD (Barrow Neurological Institute)
PRESENTER 		Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Ladha has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Ladha has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Ladha has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Ladha has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amicus. Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurosense. Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Rapa Therapeutics. Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Ladha has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ladha has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. The institution of Dr. Ladha has received research support from Biogen. The institution of Dr. Ladha has received research support from Sanofi. Dr. Ladha has received publishing royalties from a publication relating to health care.
Rafid Mustafa, MD (Mayo Clinic, Department of Neurology) Dr. Mustafa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Mustafa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PicnicHealth. Dr. Mustafa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon Biosciences. Dr. Mustafa has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon Biosciences.
Kavita M. Grover, MD, FAAN Dr. Grover has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Grover has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Grover has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Grover has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Grover has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Grover has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Catalyst.
Glenn Morrison, PhD (Annexon Biosciences) Dr. Morrison has received personal compensation for serving as an employee of Alector. Dr. Morrison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG . Dr. Morrison has stock in Alector. Dr. Morrison has received intellectual property interests from a discovery or technology relating to health care.
Liang-Yuan Lin Miss Lin has received personal compensation for serving as an employee of Johnson & Johnson.
Henk-Andre A. Kroon, MD, MBA (Annexon Biosciences) Dr. Kroon has received personal compensation for serving as an employee of Annexon Biosciences. Dr. Kroon has stock in Annexon Biosciences.
Jeffrey A. Allen, MD (University of Minnesota) Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for csl behring. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alnylam. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson and Johnson. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Annexon. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dianthus. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for CSL behring. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Takeda. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alnylam. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Johnson and Johnson.