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Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Natrunix

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must be willing comply with MTX (+folate) regimen and have no prior MTX (+folate) intolerance.
Diagnosis of RA for greater than or equal to 3 months.
Subjects must have started treatment on a stable dose of MTX (+folate) at least 12 weeks prior to the first dose of the study drug. Subjects must take a minimum of 1 mg folic acid/day or 5 mg folinic acid/week throughout study participation.
Meets the following minimum disease activity criteria at screening and baseline: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR > 3.2.
Prior treatment with biologics/JAK inhibitors is acceptable but requires a 4-half-life washout.
No history of adverse reactions to biological therapies.
Male or female, at least 18 years, willing to provide informed consent; able to attend all clinic visits and comply with study-related procedures; and able to understand and complete study-related questionnaires.

Exclusion Criteria:

History of treatment with Natrunix for any reason.
Uncontrolled intercurrent illness (e.g., ongoing infection, psychiatric illness/social situations that would limit compliance with study requirements).
Subject has a prior history of MTX (+folate) failure for the treatment of RA.
Patients must not have received any biological therapy within 8 weeks prior to randomization.
No treatment with PTK inhibitors within 4 weeks of randomization.
Clinically significant decrease in performance status within 2 weeks of intended first dose administration.
Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever was longer, prior to the first scheduled day of dosing in this study.
Pregnant or breastfeeding subjects.
Pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anaemia.
Laboratory evidence of immunodeficiency syndromes.
Patients with alcoholism or other substance abuse.
Known intolerance to MTX (+folate).
Uncontrolled heart disease, including NYHA Class III or IV congestive heart failure, ventricular arrhythmias, uncontrolled blood pressure (defined as ≥ 160/100 mm Hg), or unstable angina.
Any other severe concomitant disease, disorder, or condition that could interfere with patient's safety, ability to participate, or interpretation of study results.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Natrunix with MTX(+Folate)

Placebo with MTX(+Folate)

Arm Description

Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 100 subjects.

Placebo in combination with Methotrexate (+Folate). This arm will enroll 50 subjects.

Outcomes

Primary Outcome Measures

ACR 50 response rate at 12 weeks.

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).

Secondary Outcome Measures

ACR 20 response rate at 12 weeks.

Mean change in NRS-pain at 12 weeks

Numerical rating scale (NRS) is a validated measure used to assess chronic and acute pain using a 10-point rating scale. The rating for no pain is "0" and "worst possible pain" is 10.

Full Information

NCT ID

NCT05363891

First Posted

May 2, 2022

Last Updated

May 2, 2022

Sponsor

XBiotech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05363891

Brief Title

Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

Official Title

Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 15, 2022 (Anticipated)

Primary Completion Date

December 15, 2022 (Anticipated)

Study Completion Date

February 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XBiotech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis

Detailed Description

Natrunix will be assessed in combination with MTX (+folate) to determine the ACR 50 response rate. A total study population of 150 subjects with 1:1 randomization (75 subjects receiving Natrunix with MTX (+folate) and 75 receiving placebo with MTX (+folate)). The study duration is 17 weeks (4-week maximum screening + 12-week treatment period + 1-week follow up). Patients will undergo a preliminary assessment for study eligibility. Patients who meet the eligibility criteria will be screened and be required to provide an informed consent to acknowledge understanding and accept enrollment in the clinical study. Subjects enrolled will be randomized in a 1:1 ratio to receive either test article or placebo + MTX (+folate). Four weeks are allotted to complete all screening procedures. During the screening period, certain treatments will be washed out (discontinued), as applicable, according to eligibility requirements. Clinical assessments, collection of blood samples for Natrunix pK determination or other analysis will be performed at specified clinic visits. Natrunix + MTX + folate OR placebo + MTX + folate will be administered weekly for 12 weeks. After 13 weeks, the study will conclude. All data must be entered into the database in a timely manner, including data from the last visit. The primary endpoint for the study will be comparing the ACR 50 response between the subjects receiving Natrunix versus those receiving placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Arm 1- Natrunix with MTX(+Folate) Arm 2- Placebo with MTX(+Folate)

Masking

ParticipantInvestigator

Masking Description

Double-blind study

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Natrunix with MTX(+Folate)

Arm Type

Experimental

Arm Description

Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 100 subjects.

Arm Title

Placebo with MTX(+Folate)

Arm Type

Placebo Comparator

Arm Description

Placebo in combination with Methotrexate (+Folate). This arm will enroll 50 subjects.

Intervention Type

Drug

Intervention Name(s)

Natrunix

Other Intervention Name(s)

True Human IgG4 monoclonal antibody

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

ACR 50 response rate at 12 weeks.

Description

Time Frame

At 12 weeks from baseline

Secondary Outcome Measure Information:

Title

ACR 20 response rate at 12 weeks.

Time Frame

At 12 weeks from baseline

Title

Mean change in NRS-pain at 12 weeks

Description

Numerical rating scale (NRS) is a validated measure used to assess chronic and acute pain using a 10-point rating scale. The rating for no pain is "0" and "worst possible pain" is 10.

Time Frame

At 12 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be willing comply with MTX (+folate) regimen and have no prior MTX (+folate) intolerance. Diagnosis of RA for greater than or equal to 3 months. Subjects must have started treatment on a stable dose of MTX (+folate) at least 12 weeks prior to the first dose of the study drug. Subjects must take a minimum of 1 mg folic acid/day or 5 mg folinic acid/week throughout study participation. Meets the following minimum disease activity criteria at screening and baseline: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR > 3.2. Prior treatment with biologics/JAK inhibitors is acceptable but requires a 4-half-life washout. No history of adverse reactions to biological therapies. Male or female, at least 18 years, willing to provide informed consent; able to attend all clinic visits and comply with study-related procedures; and able to understand and complete study-related questionnaires. Exclusion Criteria: History of treatment with Natrunix for any reason. Uncontrolled intercurrent illness (e.g., ongoing infection, psychiatric illness/social situations that would limit compliance with study requirements). Subject has a prior history of MTX (+folate) failure for the treatment of RA. Patients must not have received any biological therapy within 8 weeks prior to randomization. No treatment with PTK inhibitors within 4 weeks of randomization. Clinically significant decrease in performance status within 2 weeks of intended first dose administration. Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever was longer, prior to the first scheduled day of dosing in this study. Pregnant or breastfeeding subjects. Pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anaemia. Laboratory evidence of immunodeficiency syndromes. Patients with alcoholism or other substance abuse. Known intolerance to MTX (+folate). Uncontrolled heart disease, including NYHA Class III or IV congestive heart failure, ventricular arrhythmias, uncontrolled blood pressure (defined as ≥ 160/100 mm Hg), or unstable angina. Any other severe concomitant disease, disorder, or condition that could interfere with patient's safety, ability to participate, or interpretation of study results.

12. IPD Sharing Statement

Learn more about this trial

Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

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