NCT06526377Not yet recruitingPhase 2
Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy
Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy and Safety of Vilamakitug in Participants With Active Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 15 Jun 2024
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- XBiotech, Inc.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06526377
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From Sept 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.