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Tests treatment safety and results for Rheumatoid Arthritis
Official title Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
ClinicalTrials.gov ID: NCT06581562
What this study is testing
What is AB-101?
AB-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rheumatoid arthritis.
Also referred to as ALLONK, RITUXIMAB.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General (applicable to people in all 4 studied indications)
- Males or female people, ≥ 18 years of age at the time of signing informed consent.
- Ability to understand the requirements of the study.
- Willingness to provide written informed consent.
- Willingness to comply with the study protocol procedures.
You likely can't join if
- General Exclusion Criteria (applicable to people in all 4 studied indications) 1. people who received Cyclophosphamide within 3 months 2. Laboratory...
- Immunoglobulin replacement therapies (IV or SC)
- Plasmapheresis. 8. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant, or are due to...
- History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's)
- Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty's syndrome)
- Other arthritis, including Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis...
See the full eligibility criteria
Who can join
- General (applicable to people in all 4 studied indications)
- Males or female people, ≥ 18 years of age at the time of signing informed consent.
- Ability to understand the requirements of the study.
- Willingness to provide written informed consent.
- Willingness to comply with the study protocol procedures.
- Women of childbearing potential and all male participants must agree to use two acceptable methods of contraception together to avoid pregnancy. The following are examples of acceptable methods of contraception...
- Established use of oral, inserted, injected, or implanted hormonal methods of contraception.
- Correctly placed copper containing intrauterine device (IUD).
- Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream, suppository).
- Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.
- Bilateral tubal ligation or bilateral salpingectomy.
- Oral steroids will be tapered to \<20 mg/day of prednisone (or equivalent) at least 1 week prior to the first study treatment. The tapering schedule will be at the discretion of the Investigator.
- people must have a predicted diffusing capacity for carbon monoxide (DLCO) of \>60% and a forced expiratory volume 1 (FEV1) \>70% at screening.
- Left ventricular ejection fraction (LVEF) ≥ 45% by Echocardiogram. Rituximab and AB-101 in autoimmune diseases Clinical Study Protocol V. 1.1 Confidential Page 11 of 101 April 16, 2024
- Baseline laboratory values fulfilling the following requirements to demonstrate adequate hematologic, renal, and hepatic function: RA PV MPA / GPA SLE Absolute neutrophil count (/mm3)
- 1500
- 1500
- 1500
- 1500 Platelets (/mm3)
- 100,000
- 100,000
- 100,000
- 75,000 Hemoglobin (g/dL)
- 8 Creatinine clearance (mL/min/1.73 m2)
- 60 Total serum bilirubin (mg/dL) \< 2.5 \< 2.5 \< 2.5 \< 2.5 Liver transaminases (AST/ALT/ALP) ≤ 3x ULN ≤ 3x ULN
- 3x ULN
- 3x ULN Additional Disease-specific Rheumatoid Arthritis 1\. Documented diagnosis of RA, meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA...
- In the opinion of the Investigator, there was a lack of benefit to at least two bDMARDs or one bDMARD and one tsDMARDs. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease...
- Intolerance to at least two lines of prior therapy, including bDMARDs and/or tsDMARDs. 3\. Minimum of 6 swollen joint counts (SJC) and 6 tender joint counts (TJC). Pemphigus Vulgaris
- Confirmed diagnosis of pemphigus vulgaris with active lesions.
- Positive for anti-desmoglein Dsg1 or Dsg3.
- Pemphigus Disease Area Index score of \> 10%.
- people will have tried and failed at least 12 weeks of treatment of immunosuppressive or biologic standard-of-care agent (methotrexate, azathioprine, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and...
- Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Presence of cytoplasmic Antineutrophil cytoplasmic antibody (c-ANCA) or proteinase-3 (PR3-ANCA) or myeloperoxidase ANCA (MPO-ANCA)
- Have ≥ 1 "major" item, or ≥ 3 "other" items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
- For GPA/MPA, people will have tried and failed at least 12 weeks of treatment of immunosuppressive (Cyclophosphamide, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids), or a biologic...
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria.
- Total systemic lupus erythematosus disease activity index (SLEDAI-2K) ≥ 8 at screening excluding alopecia, mucosal ulcers, and fever.
- Positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies.
- For SLE, people will have tried and failed at least 12 weeks of 2 conventional therapies which, at the discretion of the investigator, includes antimalarials, corticosteroids, immunosuppressive agents, such as...
- If receiving antimalarial drugs (e.g., hydroxychloroquine, chloroquine, quinacrine), must have used the medication for ≥ 12 weeks prior to first study treatment and at a stable dose for a minimum of 6 weeks prior to...
- If receiving immunomodulatory drugs (mycophenolate mofetil [MMF]/mycophenolic acid ≤ 2 g/day, azathioprine/6 mercaptopurine (AZA/6 MP) ≤ 2 mg/kg/day, leflunomide ≤ 40 mg/day, methotrexate (MTX) ≤ 25 mg/wk with...
What rules you out
- General Exclusion Criteria (applicable to people in all 4 studied indications) 1. people who received Cyclophosphamide within 3 months 2. Laboratory values outside the protocol-defined range at screening, unless the PI...
- Immunoglobulin replacement therapies (IV or SC)
- Plasmapheresis. 8. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant, or are due to receive such transplantation. 9\. Known past or current malignancy...
- History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's)
- Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty's syndrome)
- Other arthritis, including Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory...
- Any condition, including potential flares or new infected or non-infected lesions that would, in the investigator's judgment, interfere with full participation in the study. Granulomatosis with polyangiitis (GPA) /...
- Drug-induced lupus.
- Participants with a history of severe anti-phospholipid syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- Plantation, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plantation, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.