Status:
NOT_YET_RECRUITING
Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Lead Sponsor:
XBiotech, Inc.
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 enrollme...
Eligibility Criteria
Inclusion
- Positive for HLA-B27 and have at least 2 additional SpA features OR Positive for HLA-B27 and has radiological evidence of sacroiliitis from either X-ray or MRI from patient's medical records.
- Must have active disease at screening, according to either Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), with disease severity of ≥ 4 or ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score - C Reactive Protein) ≥ 2.1
- Subject must be DMARD naive, including those who previously declined DMARD treatment options, OR previously discontinued DMARD treatment after initial trial of no more than 12 total weeks
Exclusion
- History of treatment with Natrunix
- Have received any prior, or are currently receiving, treatment with opiates, csDMARDS, biologic DMARDs, JAK inhibitors, or other immunomodulatory agents for more than 12 weeks at any point prior to enrollment OR within 12 weeks prior to enrollment
- Treatment with more than one csDMARD (such as methotrexate and sulfasalazine etc.) , biologic DMARD (such as Etanercept and Infliximab etc.), JAK inhibitor (such as Tofacitinib and Upadacitinib etc.), or any combination thereof prior to enrollment Currently requiring regular dosing regimen corticosteroids (excluding PRN dosing) Treatment with biologics that target CD20 (Rituximab or any other anti-CD20 antibody) prior to enrollment
- Clinically significant laboratory abnormalities per PI's discretion
- Positive for active HIV, hepatitis B or C
Key Trial Info
Start Date :
August 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06526377
Start Date
August 15 2026
End Date
April 30 2027
Last Update
December 15 2025
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