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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.
Researchers will compare vilamakitug to a placebo (no active drug) to see if the study drug works in axSpA patients to treat symptoms. Participants will take the assigned study treatment for 16 weeks for double blind period and potentially 12 weeks for open label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vilamakitug | Experimental | weekly dose of vilamakitug |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vilamakitug | Drug | Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment of Disease Activity (PGADA) using Q3 of ASDAS-CRP | Baseline to week 16 | |
| Spinal pain [Numeric Rating Scale (NRS) using Question 2 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] | Baseline to week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XBiotech Clinical | Contact | (512) 386-2900 | clinicaltrials@xbiotech.com | |
| XBiotech Clinical | Contact | 512.386.2900 | clinicaltrials@xbiotech.com |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D013167 | Spondylitis, Ankylosing |
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 2 study. Eligible participants will be randomized in a 2:1 ratio to receive either vilamakitug or a placebo.
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| placebo | Drug | placebo |
|
| Physical function using Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline to week 16 |
| Inflammation, defined as the mean of Questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline to week 16 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |