Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-… (NCT06581562) | Clinical Trial Compass
RecruitingPhase 1
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
United States30 participantsStarted 2024-05-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or female subjects, ≥ 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 including:
✓. Established use of oral, inserted, injected, or implanted hormonal methods of contraception.
✓. Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream, suppository).
Exclusion criteria
✕. 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.
✕. 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)
What they're measuring
1
Incidence of adverse events and relationship to study drug
Timeframe: From the time of consent through 104 weeks after initiation of study treatment
2
Incidence of Serious Adverse Events (SAE) and causality assessment
Timeframe: From the time of consent through 104 weeks after initiation of study treatment
3
Total hospitalizations, duration of hospitalizations through the course of the study
Timeframe: From the time of consent through 104 weeks after initiation of study treatment
✕. 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 arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA.
✕. 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.
✕. Drug-induced lupus.
✕. Participants with a history of severe anti-phospholipid syndrome.