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vilamakitug · 1 trial · 4 indications
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).
| Arm | Type | Description |
|---|---|---|
| vilamakitug | EXPERIMENTAL | weekly dose of vilamakitug |
| placebo | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| vilamakitug | DRUG | Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human. |
| placebo | DRUG | placebo |
Inclusion Criteria: 1. 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. 2. Must meet the ASAS-SP...
Vilamakitug is an investigational small molecule being developed for axial spondyloarthritis, a form of inflammatory arthritis affecting the spine and sacroiliac joints. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in patients with ankylosing spondylitis, radiographic axial spondyloarthritis, and non-radiographic axial spondyloarthritis.
Vilamakitug is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat axial spondyloarthritis, a chronic inflammatory condition. Clinical trials are evaluating its efficacy and safety in patients with this condition, though the exact mechanism of action remains unspecified.
Vilamakitug is being developed by XBiotech Inc., a biotechnology company traded on the NASDAQ under the ticker symbol XBIT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with axial spondyloarthritis. XBiotech is responsible for the drug's development and regulatory activities.
Vilamakitug is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is designed to assess the drug's efficacy and safety in patients with axial spondyloarthritis, including those with ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Vilamakitug is being studied in a Phase 2 clinical trial with the identifier NCT06526377. The trial, titled 'Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy,' is a randomized, double-blind, placebo-controlled study enrolling 150 participants aged 18 years and older. The trial is not yet recruiting and is evaluating the drug in axial spondyloarthritis, including ankylosing spondylitis and related conditions.
Vilamakitug is a distinct investigational drug with no alternative names listed. It is being developed by XBiotech Inc. for the treatment of axial spondyloarthritis. The drug is currently in Phase 2 clinical trials and is not yet approved for use. No other names or aliases for vilamakitug have been identified.