Natrunix Versus Methotrexate in Rheumatoid Arthritis

NCT05363917 | Unknown Phase 2 FDA Drug

• 1 other identifier: 2022-PT059
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix versus MTX (+folate) for the Treatment of Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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).

  At 12 weeks from baseline

Secondary Outcomes (2)

• ACR 20 response rate at 12 weeks.

  At 12 weeks from baseline

• Mean change in NRS-pain at 12 weeks.

  At 12 weeks from baseline

Study Arms (2)

Natrunix with MTX placebo (+Folate)

EXPERIMENTAL

Natrunix 400mg, subcutaneous injection with oral MTX placebo (+Folate). This arm will enroll 100 subjects.

Drug: Natrunix with MTX placebo (+folate)

Natrunix Placebo with MTX(+Folate)

ACTIVE COMPARATOR

Natrunix Placebo, subcutaneous injection with oral MTX(+Folate). This arm will enroll 50 subjects.

Drug: Natrunix placebo with MTX (+folate)

Interventions

Natrunix with MTX placebo (+folate) DRUG

True Human IgG4 monoclonal antibody that neutralizes Interleukin-1α

Natrunix with MTX placebo (+Folate)

Natrunix placebo with MTX (+folate) DRUG

Natrunix placebo with MTX (+folate)

Natrunix Placebo with MTX(+Folate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be willing comply with MTX regimen (+folate) and have no prior MTX (+folate) intolerance.
• Subject has no prior history of MTX (+folate) failure for the treatment of RA.
• Diagnosis of RA for greater than or equal to 3 months.
• 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.
• Normal CBC, hepatic and bone marrow function according to the site's institutional guidelines.
• 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.

You may not qualify if:

• 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.
• Subjects received MTX (+folate) for any reason for the previous 6 weeks prior to randomization.
• Patients must not have received any biological therapy within 8 weeks prior to randomization.
• No treatment with protein tyrosine kinase (PTK) inhibitors within 4 weeks of randomization.
• Investigational therapy administered 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.
• Patients with alcoholism or other substance abuse.
• 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 concomitant disease, disorder, or condition that could interfere with patient's safety, ability to participate, or interpretation of study results.

Sponsors & Collaborators

• XBiotech, Inc.: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Natrunix with MTX placebo (+folate) Arm 2: Natrunix placebo with MTX (+folate)

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start: June 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: February 15, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05