Clinical trial NCT06526377: Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Official title: Phase II, Double Blind, Placebo Controlled, Randomized Study Examining Natrunix in Combination With Standard of Care in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Axial Spondyloarthritis
Lead sponsor: XBiotech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Assessment of Spondyloarthritis International Society (ASAS) criteria will be used to determine proportion of subjects achieving 40% Improvement (ASAS40 response)
timeFrame: At 12 weeks from Baseline
Secondary outcomes:
measure: Improvement/Deterioration in Patient's Global Assessment of Disease (PGA) Activity (using Numerical Rating Scale (NRS))
timeFrame: At 12 weeks from Baseline
measure: Pain assessment (using Numerical Rating Scale (NRS))
timeFrame: At 12 weeks from Baseline
measure: Improvement/Deterioration in Function (Bath Ankylosing Spondylitis Functional Index (BASFI))
timeFrame: At 12 weeks from Baseline
measure: Improvement/Deterioration in inflammation (mean of questions 5 and 6 on the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])
timeFrame: At 12 weeks
Other outcomes:
measure: ASAS40 response
timeFrame: At Weeks 1, 3, 5, 8 and 10 from Baseline
measure: ASAS20 response
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: ASAS50 response
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: ASAS70 response
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/deterioration in Patient's Global Assessment (PGA) of Disease Activity (using Numerical Rating scale (NRS)) both average and worst
timeFrame: At Weeks 1, 3, 5, 8 and 10 from Baseline
measure: Pain Assessment (using Numerical Rating Scale (NRS)) both average and worst
timeFrame: At Weeks 1, 3, 5, 8 and 10 from Baseline
measure: Improvement/deterioration in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/deterioration in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: At Weeks 1, 3, 5, 8 and 10 from Baseline
measure: Improvement/deterioration in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/Deterioration in Tender Joint Count (TJC)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/Deterioration in Swollen Joint Count (SJC)
timeFrame: At Week 1, 3, 5, 8, 10, and 12 from Baseline
measure: Study Emergent Anterior Uveitis (AU)
timeFrame: At Weeks 0, 5 and 12 from Baseline
measure: Improvement/Deterioration of Anterior Uveitis symptoms using Ocular Pain Assessment Survey (OPAS)
timeFrame: At 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/Deterioration of Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12. from Baseline
measure: Evaluator's (Physician's) Global Assessment of Disease (EGA)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/Deterioration in response of Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: At Weeks 1, 3, 5, 8, 10, and 12 from Baseline
measure: Improvement/Deterioration in inflammation (mean of questions 5 and 6 on the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])
timeFrame: At Weeks 1, 3, 5, 8 and 10 from Baseline
measure: Number of subjects with increased dosage/new SOC medications
timeFrame: At Weeks 3, 8 and 12 from Baseline
measure: Number of subjects with reduced/discontinued SOC medications
timeFrame: At Weeks 3, 8 and 12 from Baseline
measure: AEs and SAEs
timeFrame: 7 days from last dose
measure: Number of Participants with Clinically Significant Changes in Physical Examination Findings using the Physical Exam Assessment during the course of the study
timeFrame: up to 24 weeks
measure: Number of Participants with Clinically Significant Changes in Vital Signs during the course of the study
timeFrame: up to 24 weeks
measure: Number of participants with clinically significant abnormal value in laboratory test results which represent a change from pre-study values during the course of the study
timeFrame: up to 24 weeks
measure: ASAS40 response
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: ASAS20 response
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: ASAS50 response
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: ASAS70 response
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Patient's Global Assessment of Disease Activity (using Numerical Rating Scale (NRS)) both average and worst
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Pain Assessment (using Numerical Rating Scale (NRS)) both average and worst
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Tender Joint Count (TJC)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Swollen Joint Count (SJC)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Study Emergent Anterior Uveitis (AU)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration of Anterior Uveitis symptoms using Ocular Pain Assessment Survey (OPAS)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Evaluator's (Physician's) Global Assessment of Disease (EGA)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in response of Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Improvement/Deterioration in inflammation (mean of questions 5 and 6 on the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Number of subjects with increased dosage/new SOC medications
timeFrame: At OLE weeks 17 and 24 from Baseline
measure: Number of subjects with reduced/discontinued SOC medications
timeFrame: At weeks 17 and 24 from Baseline
Locations:
Study officials:
References: