BIIB107 / Biogen - LARVOL DELTA

Dose Optimization of BIIB107, an Anti-Alpha-4 Integrin Monoclonal Antibody, Through Population Pharmacokinetic and Pharmacodynamic Modeling. (PubMed, J Clin Pharmacol) - P1 | "Simulations showed that 450 mg SC every 8 weeks maintained sustained α4 integrin saturation ≥70%, the therapeutic threshold for efficacy, supporting this regimen for investigation in MS patients. These findings emphasize the value of model-informed drug development in optimizing therapeutic monoclonal antibody doses and support BIIB107's further clinical advancement."

Journal • PK/PD data • CNS Disorders • Multiple Sclerosis • ITGA4

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Biogen | Active, not recruiting ➔ Completed

Trial completion

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Biogen | Trial completion date: Feb 2023 ➔ Oct 2023 | Trial primary completion date: Feb 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Biogen | Trial completion date: Oct 2022 ➔ Feb 2023 | Trial primary completion date: Oct 2022 ➔ Feb 2023

Trial completion date • Trial primary completion date

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Biogen | Trial completion date: Dec 2021 ➔ Oct 2022 | Trial primary completion date: Dec 2021 ➔ Oct 2022

Trial completion date • Trial primary completion date

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Biogen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • PCR