Health TrialsbyHealthPanel

Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy

ConditionsAxial SpondyloarthritisAnkylosing Spondylitisr-axSpANr-axSpA
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXBiotech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • vilamakitug

    Drug

    Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human.

  • placebo

    Drug

    placebo

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: vilamakitugExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline to week 16

Secondary outcomes

1

Patient Global Assessment of Disease Activity (PGADA) using Q3 of ASDAS-CRP

Time frame
Baseline to week 16
2

Spinal pain [Numeric Rating Scale (NRS) using Question 2 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)]

Time frame
Baseline to week 16
3

Physical function using Bath Ankylosing Spondylitis Functional Index (BASFI)

Time frame
Baseline to week 16
4

Inflammation, defined as the mean of Questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Time frame
Baseline to week 16

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

XBiotech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: