An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)

Conditions

• Guillain-Barre Syndrome

Eligibility Criteria

Sex

ALL

Age

12 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Tanruprubart — DRUG
  Solution for IV infusion.

Study Details

The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.

Key Dates

Start date

Sep 12, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tanruprubart
  Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.

Primary Outcome Measure

Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t) [ Time Frame: Up to Day 15 ]

Central Contacts

• Study Coordinator
  1-650-822-5500
  [email protected]

Locations (12)

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