Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis

Launched by XBIOTECH, INC. · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Natrunix for people with a condition known as axial spondyloarthritis, which causes inflammation in the spine and pelvis. The trial is designed to see how well Natrunix works when taken alongside standard treatments that patients usually receive for this condition. It is a double-blind study, meaning neither the participants nor the researchers will know who is receiving the actual treatment and who is receiving a placebo (a non-active treatment) to ensure fair results.

To be eligible for this trial, participants need to be between 65 and 74 years old and must test positive for a specific marker called HLA-B27. They should also show signs of active disease, meaning their symptoms are significant enough to require treatment. Importantly, those who have never received certain types of medications for this condition, or who have only tried them briefly before stopping, may qualify. Participants can expect regular check-ups and assessments throughout the trial to monitor their progress and any side effects. If you or someone you know fits these criteria and is interested in learning more, this trial may be a valuable opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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
• • 3. 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 Criteria:
• • 1. History of treatment with Natrunix
• • 2. 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
• • 3. 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
• • 4. Clinically significant laboratory abnormalities per PI's discretion
• • 5. Positive for active HIV, hepatitis B or C