NCT06526377

Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis

Phase II, Double Blind, Placebo Controlled, Randomized Study Examining Natrunix in Combination With Standard of Care in HLA-B27 Positive Subjects With Axial Spondyloarthritis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: XBiotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Double-blind, placebo-controlled, randomized trial of Natrunix in combination with Standard of Care in patients with Axial Spondyloarthritis

Detailed description

This is Double-blind, placebo-controlled, randomized trial examining Natrunix in combination with Standard of Care. Qualified subjects will be consented and screened for study eligibility and enrollment. Enrolled subjects will be randomized in a 2:1 ratio to receive either 400 mg Natrunix or placebo. All subjects who enter the study must be on a stable background standard of care (SOC) that they were receiving for at least 8 weeks prior to study enrollment. Enrolled subjects must meet 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis, be HLA-B27 positive, and have active disease as defined by a BASDAI score ≥4 or an ASDAS-CRP \>2.1. Subjects will receive once weekly injection of Natrunix or placebo in addition to SOC for 12 weeks. The study will conclude after 12 weeks followed by a 12-week open label extension phase and one-week follow-up.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Natrunix	Natrunix is a monoclonal antibody preparation. Natrunix antibody is indistinguishable from a natural antibody isolated from a healthy human. Natrunix is expected to be the safest, most effective therapy for alleviating inflammatory pain and mitigating damage, mainly in the spine and sacroiliac joints, in AxSpA patients.
DRUG	Placebo	Placebo

Timeline

• Start date: 2026-08-15
• Primary completion: 2027-02-28
• Completion: 2027-04-30
• First posted: 2024-07-29
• Last updated: 2025-12-15

Regulatory

• FDA-regulated drug study