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Also known as True Human IgG4 monoclonal antibody, vilamakitug, XB2001
Natrunix · 3 trials · 5 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).
| 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. |
| 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...
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Natrunix is being developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. It is studied in combination with methotrexate in adults 18 years and older. Natrunix is an investigational small molecule and has not been approved for any use.
Natrunix is developed by XBiotech Inc., which trades on the Nasdaq under the ticker XBIT. XBiotech is the sponsor of the clinical program evaluating Natrunix in rheumatoid arthritis.
Natrunix is in Phase 2 clinical development for rheumatoid arthritis. Two Phase 2 trials have been conducted, one completed and one not yet recruiting. Natrunix is investigational and has not received FDA approval.
Natrunix has been studied in two Phase 2 rheumatoid arthritis trials. NCT05363891, completed, enrolled 243 patients in the United States. NCT06590090, not yet recruiting, plans to enroll 108 patients. Both trials test Natrunix with methotrexate in adults.
Natrunix trials are randomized, double-blind, and placebo-controlled, combining Natrunix with methotrexate in adults with rheumatoid arthritis. The completed Phase 2 trial NCT05363891 enrolled 243 patients, and the planned Phase 2 trial NCT06590090 is set to enroll 108 patients.