Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2023-02-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XBiotech, Inc.

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.