Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment

Sponsor
XBiotech, Inc.
Study ID
NCT06590090
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Natrunix 400 mg — BIOLOGICAL
    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.
  • Placebo — DRUG
    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
  • Methotrexate (MTX) — DRUG
    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.

Study Details

Approximately 108 subjects will be randomized in 2 arms in 2:1 ratio to receive weekly subcutaneous injections of either 400mg Natrunix + MTX weekly or placebo + MTX weekly for 14 weeks. At the week 14 visit subjects in both arms will undergo a safety follow up visit OR begin receiving biweekly subcutaneous injections of 400mg Natrunix for 14 weeks as part of an Open Label Extension (OLE). The study will last for a maximum of 33 weeks, including: a screening period of up to 4 weeks, a 14-week double-blinded treatment phase followed by a 14-week open label extension phase and one-week follow-up.

Key Dates

First listed
Sep 19, 2024
Start date
Jul 15, 2026
Status verified
Dec 2025
Primary completion
Jan 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 400mg Natrunix + MTX weekly
    Subjects will receive 400mg Natrunix and MTX weekly
  • Experimental: Placebo+ MTX weekly
    Subjects will receive placebo and MTX weekly

Primary Outcome Measure

ACR 20 response [ Time Frame: at 14 weeks from baseline ]

Central Contacts

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