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Phase 2Not yet recruiting

Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment

Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate for the Treatment of Rheumatoid Arthritis

Sponsor
XBiotech, Inc. (Industry)
Enrolment
108 planned
Conditions
Rheumatoid Arthritis
Interventions
Natrunix 400 mg; Placebo; Methotrexate (MTX)
Ages
adults, older adults
Registry
NCT06590090

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • ACR 20 response

History

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Last registry update

  5. Registered