Axial SpondyloarthritisPhase 2V-SPINENCT06526377
Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy
A Phase 2 study testing vilamakitug in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by XBiotech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpA
- What is being tested?
- vilamakitug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must meet the ASAS-SPARTAN 2025 revised classification criteria for axial spondyloarthritis.
- Active disease at screening, defined by BASDAI ≥ 4 and ASDAS-CRP ≥ 2.1
- Participants should have received prior NSAIDs or have documented inadequate response to NSAIDs
- Participants may be biological DMARD-naïve or have documented failure of no more than 1 prior biologic DMARD (≥12 weeks)
Who cannot join
- History of treatment with vilamakitug
- Any prior exposure to > 1 biologic DMARD
- Any exposure to JAK or TYK2 inhibitors
- Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to enrollment
- Participation in another interventional clinical study within 30 days or 5 half-lives (whichever is longer) prior to enrollment, and during the study
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy and Safety of Vilamakitug in Participants With Active Axial Spondyloarthritis
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.
Read the 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.
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpA, Nr-axSpA
- Being tested
- vilamakitug, placebo
- Keywords
- axSpA
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vilamakitugDrug
Also called XB2001, Natrunix
Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| vilamakitug | Experimental | weekly dose of vilamakitug Receives: Drug: vilamakitug |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving ASAS40.
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).
Measured: Baseline to week 16
Secondary outcomes (4)
Patient Global Assessment of Disease Activity (PGADA) using Q3 of ASDAS-CRP
Measured: Baseline to week 16
Spinal pain [Numeric Rating Scale (NRS) using Question 2 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)]
Measured: Baseline to week 16
Physical function using Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: Baseline to week 16
Inflammation, defined as the mean of Questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XBiotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526377
- Sponsor's protocol ID
- PT064
- Acronym
- V-SPINE
- Status last verified
- May 2026
- First submitted
- 15 Jun 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No