Ankylosing Spondylitis, Axial Spondyloarthritis, Nr-axSpA, r-axSpA
Conditions
Keywords
axSpA
Brief summary
The goal of this clinical trial is to find out if the study drug will work as a new therapy for axSpA patients. This study is placebo-controlled, and evaluates if study drug can treat symptoms of axSpA, including global disease activity, pain, function and inflammation.
Detailed description
Researchers will compare vilamakitug to a placebo (no active drug) to see if the study drug works in axSpA patients to treat symptoms. Participants will take the assigned study treatment for 16 weeks for double blind period and potentially 12 weeks for open label extension.
Interventions
DRUGvilamakitug
Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human.
DRUGplacebo
placebo
Sponsors
XBiotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 2 study. Eligible participants will be randomized in a 2:1 ratio to receive either vilamakitug or a placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥18 and ≤65 years, with body weight \>40 kg at screening, who are willing to provide informed consent, attend all clinic visits, comply with study-related procedures and able to understand and complete study-related questionnaires. 2. Must meet the ASAS-SPARTAN 2025 revised classification criteria for axial spondyloarthritis. 3. Active disease at screening, defined by BASDAI ≥ 4 and ASDAS-CRP ≥ 2.1 4. Participants should have received prior NSAIDs or have documented inadequate response to NSAIDs 5. Participants may be biological DMARD-naïve or have documented failure of no more than 1 prior biologic DMARD (≥12 weeks)
Exclusion criteria
1. History of treatment with vilamakitug 2. Any prior exposure to \> 1 biologic DMARD 3. Any exposure to JAK or TYK2 inhibitors 4. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to enrollment 5. Participation in another interventional clinical study within 30 days or 5 half-lives (whichever is longer) prior to enrollment, and during the study 6. Female participants who are pregnant or breastfeeding at screening, or who intend to become pregnant during the study or within 8 weeks after the last dose of investigational product (IP), and male participants who intend to father a child during the study or within 8 weeks after the last dose of IP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving ASAS40. | Baseline to week 16 | ASAS40 response is defined at least a 40% improvement in at least three of the four main ASAS domains, with no worsening in the remaining domain: Patient Global Assessment of Disease Activity (Q3 of ASDAS-CRP), Pain Assessment (BASDAI Q2), physical function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and Inflammation (represented by the mean of the two morning stiffness BASDAI questions Q5 and Q6). |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Assessment of Disease Activity (PGADA) using Q3 of ASDAS-CRP | Baseline to week 16 |
| Spinal pain [Numeric Rating Scale (NRS) using Question 2 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] | Baseline to week 16 |
| Physical function using Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline to week 16 |
| Inflammation, defined as the mean of Questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline to week 16 |
Contacts
CONTACTXBiotech Clinical
Outcome results
None listed