Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis

Phase 2

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo in combination with Standard of Care	Placebo	This arm will have 20 subjects receiving Placebo in Combination with Standard of Care in HLA-B27 Positive Patients with Axial Spondyloarthritis
Natrunix 400 mg Natrunix in Combination with Standard of Care	Natrunix	This arm will have 40 subjects receiving Natrunix in Combination with Standard of Care in HLA-B27 Positive Patients with Axial Spondyloarthritis

Primary Outcome Measures

Name	Time	Method
Assessment of Spondyloarthritis International Society (ASAS) criteria will be used to determine proportion of subjects achieving 40% Improvement (ASAS40 response)	At 12 weeks from Baseline	In this study, sponsor will assess the safety and effectiveness of Natrunix (human antibody preparation) in combination with Standard of Care to determine the ASAS40 response rate. ASAS response is the measure of improvement in percentage of Axial Spondyloarthritis (AxSpA) disease. Patients who achieved at least 40% improvement on Assessment of Spondyloarthritis International Society (ASAS40) at week 12 will be considered as an ASAS40 responder for the primary analysis.

Secondary Outcome Measures

Name	Time	Method
Improvement/Deterioration in Patient's Global Assessment of Disease (PGA) Activity (using Numerical Rating Scale (NRS))	At 12 weeks from Baseline	A patient global assessment of Disease (PGA) will be administered to assess your overall treatment response and disease status in AxSpa. Subjects will be evaluated to estimate disease activity on a 0-10 scale where 10 is maximum worsening.
Pain assessment (using Numerical Rating Scale (NRS))	At 12 weeks from Baseline	Numerical Rating Scale for Pain (NRS) diary will be given to rate subject's pain from 0-10 (no pain to highest pain) for average pain and worst pain in past 24 hours.
Improvement/Deterioration in Function (Bath Ankylosing Spondylitis Functional Index (BASFI))	At 12 weeks from Baseline	The Bath Ankylosing Spondylitis Functional Index (BASFI) will be administered to assess the degree of subject's functional limitation. Questionnaires will ask the subjects the rate difficulty in daily activity on 0-10 scale where 0 is easy and 10 is impossible.
Improvement/Deterioration in inflammation (mean of questions 5 and 6 on the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])	At 12 weeks	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will be administered to access subject's AxSpa. It to evaluate symptoms such as spinal pain, joint pain, morning stiffness duration/ severity, fatigue, and discomfort experienced. These symptoms will be assessed on scale of 0-10 where 0 is none and 10 is very severe.