Testing safety and efficacy of a live bacterial therapy for the treatment of active Rheumatoid Arthritis.
A Randomised, Double-Blind, Placebo-Controlled, Parallel Dose Comparison Study Evaluating Safety and Efficacy of SVT-6A4710 in Adults with active Rheumatoid Arthritis.
Servatus Ltd
45 participants
Nov 21, 2022
Interventional
Conditions
Summary
The aim of this study is to evaluate the efficacy and safety of SVT-6A4710 as a treatment for active Rheumatoid Arthritis. The treatment consists of a combination of carefully selected bacteria. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many health conditions. Bacteria play an important role in the function of the immune system, digestive health, inflammation and have anti-microbial properties. Several research studies have found treatment with beneficial bacteria to relieve Arthritic symptoms. This study will help determine how safe and effective SVT-6A4710 is as an adjunct therapy to synthetic disease-modifying anti-rhuematic drugs (DMARDs) in treating symptoms of Rheumatoid Arthritis.
Eligibility
Inclusion Criteria20
- Male and female Participants aged 18 to 80 years, capable of providing verbal informed consent and able to attend the clinic as required for the study;
- Participants must have active Rheumatoid Arthritis meeting classification criteria according to the 2010 ACR/EULAR guidelines with a score equal to or greater than 6/10;
- Participants must have a Clinical Disease Activity Index (CDAI) Score greater than 10;
- Participants may or may not be taking conventional DMARD therapies;
- If taking DMARD therapy, they must have been taking it continuously for at least 3 months prior to the first dose of study drug and be on a stable weekly dose for at least 4 weeks prior to the first dose of study drug and be maintained for the study duration, as:
- a. Sulfasalazine less than or equal to 2000 mg/day
- b. Hydroxychloroquine less than or equal to 200 mg/day
- c. Leflunomide less than or equal to 20 mg/day
- d. Azathioprine less than or equal to 4 mg/kg per day
- e. Methotrexate less than or equal to 25 mg/week
- If taking low dose prednisone, they must be taking it continuously for 3 months and be on a stable dose of less than 7.7 mg/day for 4 weeks prior to the first dose of the study drug. Tapering or removing prednisone from treatment plan will be based on disease activity assessed at each clinic visit;
- Must have normal differential white cell counts within reference range at screening:
- a. Lymphocytes (1.1 - 4.0 x 10^9 per L)
- b. Neutrophils (2.0 - 7.5 x 10^9 per L)
- c. Monocytes (0.2 - 1.0 x 10^9 per L)
- d. Eosinophils (0.04 - 0.4 x 10^9 per L)
- e. Basophils (0 - 0.21 x 10^9 per L)
- Participant has discontinued all disallowed concomitant medications for the required time prior to the first dose of study drug and is taking only those concomitant medications in doses and frequency allowed by the protocol;
- Females of childbearing potential (FOCBP) must test negative for pregnancy prior to enrolment in the study;
- Sexually active FOCBP and men, whose partners are FOCBP and who are not using adequate contraceptive methods, are required to use adequate contraceptive methods during participation in this trial.
Exclusion Criteria20
- Participants fulfilling any of the following criteria are not eligible for inclusion in this study.
- History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome;
- Current or previous exposure to biological DMARDs within 3 months, or Infliximab within 6 months prior to the first dose of the study drug;
- Use of high potency opioid analgesics (e.g., methadone, hydromorphone, morphine);
- Use of oral antimicrobial drugs within 4 weeks prior to the first dose of the study drug;
- Use of probiotic supplements within 2 weeks prior to the first dose of the study drug;
- History of hypersensitivity to the study drug or its excipients or to drugs of similar classes, probiotics or any antibiotics commonly used to treat bacterial infections;
- History of any infection requiring hospitalisation, parental antimicrobial therapy, or as otherwise judged clinically significant, within the 3 months prior to screening;
- History of septicaemia or bacteraemia;
- Use of any investigational drug and/or device within 4 weeks before randomisation or a period of 5 half-lives of the investigational drug, whichever is longer. Patients cannot participate in studies of other investigational compounds at any time during their participation in this study;
- Current or recent history of uncontrolled clinically significant renal, hepatic, haematological, gastrointestinal, endocrine, metabolic (including uncontrolled clinically significant hypercholesterolemia), pulmonary, cardiac, or neurological disease;
- History of, or signs and symptoms suggestive of any current, lymphoproliferative disease or lymphatic disorder, or history of malignancy of any known malignancy of any organ system with the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed);
- Those with known or suspected history of immunodeficiency;
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
- Any planned surgical procedure during the treatment period, other than that deemed by the Study Coordinator to be minor and unlikely to impact on the study and will not require the use of antibiotics;
- Females who are pregnant or breastfeeding or planning on becoming pregnant for the study period (treatment and follow-up periods);
- History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug;
- Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect patient safety;
- Inability or unwillingness to undergo repeated venepuncture (e.g., because of poor tolerability or lack of access to veins);
- Inability or unwillingness to complete repeated stool collections.
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Interventions
The study duration consists of a total of 16 weeks consisting of 12 weeks of intervention (treatment) and an additional 4 weeks as an observation period (no treatment). Participants will be provided with 21 x 250 mL bottles in total containing the investigational medicine(s), or placebo. Participants will take 25 mL of SVT-6A4710 oral liquid or placebo oral liquid twice daily for 12 weeks. Dose 1 of SVT-6A4710 contains 1.5 x 10^9 colony forming units (CFU) of bacterial species (1.5 Billion CFU per 25 mL dose). Dose 2 of SVT-6A4710 contains 1.5 x 10^11 CFU of bacterial species (150 Billion per 25 mL dose). Placebo will contain inactive ingredients only. Participants are required to record each dose taken. Participants will record their adherence to the intervention in a participant diary, any adverse events and any concomitant medications taken during the study period.
Locations(1)
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ACTRN12621001657819