Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy
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
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
Treatments tested in this trial
- vilamakitug
- placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov