Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis

XBiotech

Status and phase: Not yet enrolling; Phase 2

Conditions: Axial Spondyloarthritis

Treatments: Drug: Placebo; Drug: Natrunix

Study type: Interventional

Funder types: Industry

Identifiers

NCT06526377

PT064

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Natrunix 400 mg Natrunix in Combination with Standard of Care

Experimental group

Description:

This arm will have 40 subjects receiving Natrunix in Combination with Standard of Care in HLA-B27 Positive Patients with Axial Spondyloarthritis

Treatment:

Drug: Natrunix

Placebo in combination with Standard of Care

Experimental group

Description:

This arm will have 20 subjects receiving Placebo in Combination with Standard of Care in HLA-B27 Positive Patients with Axial Spondyloarthritis

Treatment:

Drug: Placebo