NCT03241108

Study of an Anti-TLR4 mAb in Rheumatoid Arthritis

Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Light Chain Bioscience - Novimmune SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Detailed description

The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1). Patients will receive NI-0101 or placebo infusions up to a maximum of 6 administrations (every two weeks for 12 weeks). All patients will continue receiving a stable dose of MTX. After 12 weeks, patients will enter the follow up period with monthly visits for a minimum of 12 weeks.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	NI-0101	Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody targeting TLR4
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-06-20
• Completion: 2018-06-20
• First posted: 2017-08-07
• Last updated: 2018-08-14

Locations

19 sites across 7 countries: Bosnia and Herzegovina, Bulgaria, Georgia, Hungary, Moldova, Poland, Serbia