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Natrunix · 3 trials · 2 indications
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 |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Each participant receives one single subcutaneous injection of 0.5 ml (Cohort 1), 1 ml (Cohort 2), or 2 ml (Cohort 3) of Placebo. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | DRUG | Placebo is a sterile liquid solution filled into a 2 mL glass pre-filled syringe, suitable for subcutaneous injection, containing the exact same buffer matrix used for Natrunix drug product |
| 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. Weight \> 40 kg 2. Diagnosis of moderate to severe RA according to 2010 ACR/EULAR classification criteria. 3. Patients must be methotrexate-inadequate responders. a. Persistent moderate to severe RA disease activity (i.e., criteria #2 above) despite ongoing treatment with...
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Natrunix is an investigational monoclonal antibody being studied for rheumatoid arthritis and for pharmacokinetics. It is being evaluated in combination with methotrexate for rheumatoid arthritis treatment. Natrunix is not approved by the FDA and remains in clinical development.
Natrunix is being developed by XBiotech Inc., a biopharmaceutical company traded on NASDAQ under the ticker XBIT. XBiotech is conducting clinical trials of Natrunix in the United States.
Natrunix is in Phase 2 clinical development for rheumatoid arthritis. A Phase 1 study in healthy volunteers has been completed, and two Phase 2 trials in rheumatoid arthritis have been conducted or planned. Natrunix is investigational and not yet approved.
Natrunix has been studied in three clinical trials: NCT05099510, a completed Phase 1 pharmacokinetics study in healthy volunteers; NCT05363891, a completed Phase 2 trial in rheumatoid arthritis; and NCT06590090, a Phase 2 trial in rheumatoid arthritis that is not yet recruiting.
Yes, Natrunix is also known as Natrunix 400 mg. This alternative name refers to the same investigational monoclonal antibody being developed by XBiotech Inc. for rheumatoid arthritis.
Natrunix is a monoclonal antibody, a type of biologic drug. As a monoclonal antibody, it is designed to bind to a specific target involved in disease. However, the specific molecular target of Natrunix has not been disclosed in available information.