Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy

Sponsor
XBiotech, Inc.
Study ID
NCT06526377
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • vilamakitug — DRUG
    Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human.
  • placebo — DRUG
    placebo

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: vilamakitug
    weekly dose of vilamakitug
  • Placebo Comparator: placebo
    placebo

Primary Outcome Measure

Percentage of participants achieving ASAS40. [ Time Frame: Baseline to week 16 ]

Central Contacts

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