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Also known as XB2001, Natrunix
vilamakitug · 4 trials · 6 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).
The American College of Rheumatology (ACR) response criteria for rheumatoid arthritis (RA) are used to measure how effective study drug is in this study.
The ACR is a measure used in clinical practice and clinical trial to assess medication efficacy in patients with RA, by notating improvements in swelling and tenderness in designated joints, as well as improvements in at least 3 out of 5 other categories. The other categories assessed are patient global assessment of disease activity, physician global assessment of disease activity, patient reported pain scale, disability/functionality questionnaire response, and acute phase reactant levels (CRP and ESR).
Participants were monitored for treatment-emergent adverse events (TEAEs) immediately after the initial subcutaneous administration on Day 0 (Visit 1) through the final follow-up on Day 28 (Visit 7). All identified adverse events were documented and graded for severity according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."
| Arm | Type | Description |
|---|---|---|
| vilamakitug | EXPERIMENTAL | weekly dose of vilamakitug |
| placebo | PLACEBO_COMPARATOR | placebo |
| 400mg Natrunix + MTX weekly | EXPERIMENTAL | Subjects will receive 400mg Natrunix and MTX weekly |
| Placebo+ MTX weekly | EXPERIMENTAL | Subjects will receive placebo and MTX weekly |
| Natrunix 200mg with MTX(+Folate) | EXPERIMENTAL | Natrunix 200mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Natrunix 400mg with MTX(+Folate) | EXPERIMENTAL | Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Placebo with MTX(+Folate) | PLACEBO_COMPARATOR | Placebo in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Natrunix | ACTIVE_COMPARATOR | Each participant receives one single subcutaneous injection of 100 mg (Cohort 1), 200 mg (Cohort 2), or 400 mg (Cohort 3) of Natrunix. |
| Name | Type | Description |
|---|---|---|
| vilamakitug | DRUG | Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human. |
| placebo | DRUG | placebo |
| Natrunix 400 mg | BIOLOGICAL | The active ingredient of Natrunix is an IgG4 monoclonal antibody indistinguishable from that naturally occurring in an IL-1a-immune healthy human. Natrunix is formulated as 200 mg/mL sterile liquid in a stabilizing isotonic formulation buffered to pH 7.0. The product is filled into a 2 mL glass pre-filled syringe suitable for subcutaneous injection. The drug product is formulated and buffered to a neutral body pH of 7.0. |
| Methotrexate (MTX) | DRUG | Methotrexate may be administered in pill form by mouth, as liquid by mouth, or by subcutaneous injection.Subjects enrolled in this study should be receiving a stable minimum weekly dose of 10mg. Weekly methotrexate should not exceed 25 mg/week. |
| Natrunix | DRUG | Natrunix is a unique kind of drug-an immunoglobulin cloned from a naturally occurring immune response from a healthy human donor. Natrunix blocks inflammation in a unique way-it is the only therapeutic that exclusively neutralizes interleukin-1α (IL-1α), a crucial mediator of interleukin-1 inflammation. Targeting IL-1α directly using a natural human monoclonal antibody may provide a safer and more effective means of blocking interleukin-1 in rheumatoid arthritis. |
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.