Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

NCT05363891 | Completed Phase 2 FDA Drug

• 1 other identifier: 2021-PT055
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR 20 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 50 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 (3)

Natrunix 200mg with MTX(+Folate)

EXPERIMENTAL

Natrunix 200mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.

Drug: Natrunix

Natrunix 400mg with MTX(+Folate)

EXPERIMENTAL

Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.

Drug: Natrunix

Placebo with MTX(+Folate)

PLACEBO COMPARATOR

Placebo in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.

Drug: Placebo

Interventions

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.

Also known as: True Human IgG4 monoclonal antibody

Natrunix 200mg with MTX(+Folate); Natrunix 400mg with MTX(+Folate)

Placebo DRUG

Placebo

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:

• Patients may be included in the study if they meet all of the following criteria:
• Weight \> 40 kg
• Diagnosis of moderate to severe RA according to 2010 ACR/EULAR classification criteria.
• Patients must be methotrexate-inadequate responders.
• a. Persistent moderate to severe RA disease activity (ie. criteria #2 above) despite ongoing treatment with MTX.
• Meets the following minimum disease activity criteria at screening: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR \> 3.2.
• Subject must be receiving MTX treatment at a dosage of 15-25 mg/week for a minimum of12 weeks; and be receiving a stable dose of MTX for \>4 weeks preceding randomization.
• Subjects must also be in principle agreement to remain at the pre-randomization stable dose of MTX for the entire duration of the study. Subjects must also be willing to take a minimum of 5 mg folic acid/folinic acid per week for the duration of the study.
• Male or female, at least 18 years of age, willing to provide informed consent, able to attend all clinic visits,comply with study-related procedures and able to understand and complete study-related questionnaires.
• Patients must provide at least 7 consecutive days of NRS-pain data in the subjects diary prior to the baseline visit. The NRS pain diary should ideally be completed for the 7 days immediately prior to Visit 1 (when the first dose of test drug is administered). Subjects may record more than 7 days of pain records in the diary for their baseline. At least seven consecutive days of pain diary are necessary to be eligible for enrollment in the study.
• Peripheral blood CD19+ cell count recovery to \>10 cells/uL or \>1% of total lymphocyte count (Required only for subjects who have received a Rituximab (or anti-CD20 biosimilar) infusion within 12 months prior to enrollment).
• Female patients of childbearing potential must consent to undergo a serum pregnancy test at enrollment, and urine pregnancy tests at each visit after screening. Women of non-childbearing potential include those considered to have a medical history that indicates that pregnancy is not a reasonable risk, including post-menopausal women and those with a history of hysterectomy or surgically sterilized.
• In case of female patients of childbearing potential, willingness to use one method of contraception of high efficacy during the entire study period. These methods can include but not limited to hormonal contraceptives, intrauterine devices, condoms, diaphragms, etc.
• Males participating in this clinical research study should not get a sexual partner pregnant during their participation in this research study as the effect of the study drug on sperm is not known. Male contraception methods can include but are not limited to mechanical methods (e.g., abstinence, non-vaginal intercourse), contemporary methods comprising barrier methods (e.g., spermicide, condom, sponge, diaphragm and cervical cap) and vasectomy.

You may not qualify if:

• Patients with ANY of the following will be excluded from the study:
• History of treatment with Natrunix for any reason.
• Any active, chronic, or recurrent infections. (e.g., ongoing bacterial, viral, or fungal infection).
• Comorbid severe psychiatric illness and/or complicated social situations that would limit compliance with study requirements.
• Patients with a positive result of TB test (QuantiFERON-TB Gold (QFT) at screening unless the patients can present a documentation of completion of TB treatment course by the local Health Department and a clear chest x-ray at enrollment.
• Patients must not have received any biological therapy including anakinra, rilonacept, canakinumab, adalimumab, certolizumab, etanercept, golimumab, infliximab, abatacept, tocilizumab, sarilumab, and biosimilars within 8 weeks prior to randomization.
• Treatment with JAK inhibitors within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization.
• Investigational therapy administered within a time interval less than at least 5 half-lives of the investigational agent prior to the first scheduled day of dosing in this study.
• Pregnant or breastfeeding patients.
• Patients with current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to Day 0.
• Uncontrolled heart disease, including NYHA Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled blood pressure (defined as ≥ 160/100 mm Hg), or unstable angina.
• Clinically significant laboratory abnormalities, including:
• Hemoglobin \<9.0 g/dL
• White blood cell counts \< 4000/mm3
• Absolute neutrophil count (ANC) \<1500/mm3

Sponsors & Collaborators

• XBiotech, Inc.: lead

Study Sites (26)

Medvin Clinical Research

Covina, California, 91722, United States

Location

T. Joseph Raoof MD, INC

Encino, California, 91436, United States

Location

Desert Medical Advances

Rancho Mirage, California, 92270, United States

Location

Medvin Clinical Research

Riverside, California, 92518, United States

Location

Medvin Clinical Research

Tujunga, California, 91042, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

HARAC Research Corp

Avon Park, Florida, 33825, United States

Location

Reliable Clinical Research, LLC

Hialeah, Florida, 33112, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33122, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

BioMed Research & Medical Center, LLC

Miami, Florida, 33156, United States

Location

Advanced Clinical Research of Orlando

Ocoee, Florida, 34761, United States

Location

DH Tamarac Research Center

Tamarac, Florida, 33321, United States

Location

Greater Chicago Specialty Physicians, LLC

Orland Park, Illinois, 60467, United States

Location

Greater Chicago Specialty Physicians, LLC

Schaumburg, Illinois, 60195, United States

Location

Accurate Clinical Research Inc

Lake Charles, Louisiana, 70605, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

ClinRx Research Joseph INC

Carrollton, Texas, 75007, United States

Location

Accurate Clinical Management LLC

Houston, Texas, 77089, United States

Location

Accurate Clinical Research Inc

Houston, Texas, 77089, United States

Location

Pioneer Research Solutions, INC

Houston, Texas, 77099, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

Epic Medical Research, LLC

Red Oak, Texas, 75115, United States

Location

Accurate Clinical Management, LLC

Richmond, Texas, 77469, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Overlake Arthritis and Osteoporosis Center

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Arm 1- Natrunix 200mg with MTX(+Folate) Arm 2 - Natrunix 400mg with MTX(+Folate) Arm 3- Placebo with MTX(+Folate)

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start: August 8, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

US (26)