Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

July 15, 2025

Primary Completion Date

January 15, 2026

Study Completion Date

March 15, 2026

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Natrunix 400 mg

"The active ingredient of Natrunix is an IgG4 monoclonal antibody indistinguishable from that naturally occurring in an IL-1a-immune healthy human.~Natrunix is formulated as 200 mg/mL sterile liquid in a stabilizing isotonic formulation buffered to pH 7.0. The product is filled into a 2 mL glass pre-filled syringe suitable for subcutaneous injection. The drug product is formulated and buffered to a neutral body pH of 7.0."

DRUG

Placebo

Placebo is a sterile liquid solution filled into a 2 mL glass pre-filled syringe, suitable for subcutaneous injection, containing the exact same buffer matrix used for Natrunix drug product

DRUG

Methotrexate (MTX)

Methotrexate may be administered in pill form by mouth, as liquid by mouth, or by subcutaneous injection.Subjects enrolled in this study should be receiving a stable minimum weekly dose of 10mg. Weekly methotrexate should not exceed 25 mg/week.

All Listed Sponsors
lead

XBiotech, Inc.

INDUSTRY