Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID: NCT05363891
Run by: XBiotech, Inc.
People needed: 243
Starts: 2023-08-08
Expected to finish: 2024-10-31
Last updated by the study team: 2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Platelet count <100,000/mm3
Absolute lymphocyte count (ALC) <500/mm3
eGFR <60 mL/min
Alanine Aminotransferase (ALT) >1.5x lab upper limit of normal (ULN)
Aspartate Aminotransferase (AST) >1.5x lab upper limit of normal (ULN)
Bilirubin >1.5x lab upper limit of normal (ULN)
GGT: Natrunix does not put any load on the liver. GGT levels are not assessed to determine potential risk of hepatoxicity. Rather GGT levels are used as an additional screening measure to assess for occult hepatobiliary disease that may be missed with more common liver enzyme assays given the requirement for concurrent treatment with therapeutic methotrexate throughout the study. Small excursions from normal values are acceptable based on Physician/Sponsor judgment.
Major surgery (including joint surgery) within 3 months of baseline.
Patients who have suffered severe trauma or fracture within 4 weeks of baseline.
Evidence of active hepatitis B, hepatitis C, or HIV infection.

Where it is running

Medvin Clinical Research — Covina, California, United States
T. Joseph Raoof MD, INC — Encino, California, United States
Desert Medical Advances — Rancho Mirage, California, United States
Medvin Clinical Research — Riverside, California, United States
Medvin Clinical Research — Tujunga, California, United States
Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
HARAC Research Corp — Avon Park, Florida, United States
Reliable Clinical Research, LLC — Hialeah, Florida, United States
Angels Clinical Research Institute — Miami, Florida, United States
D&H National Research Centers — Miami, Florida, United States
BioMed Research & Medical Center, LLC — Miami, Florida, United States
Advanced Clinical Research of Orlando — Ocoee, Florida, United States
DH Tamarac Research Center — Tamarac, Florida, United States
Greater Chicago Specialty Physicians, LLC — Orland Park, Illinois, United States
Greater Chicago Specialty Physicians, LLC — Schaumburg, Illinois, United States
Accurate Clinical Research Inc — Lake Charles, Louisiana, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
ClinRx Research Joseph INC — Carrollton, Texas, United States
Accurate Clinical Management LLC — Houston, Texas, United States
Accurate Clinical Research Inc — Houston, Texas, United States
Pioneer Research Solutions, INC — Houston, Texas, United States
Southwest Rheumatology Research, LLC — Mesquite, Texas, United States
Epic Medical Research, LLC — Red Oak, Texas, United States
Accurate Clinical Management, LLC — Richmond, Texas, United States
DM Clinical Research — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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