A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
NCT: NCT07029555 ·
Status: RECRUITING ·
Phase: Phase 1
· Sponsor: Novartis Pharmaceuticals
· Started: 2025-06-12
· Est. Completion: 2028-05-16
Official Summary
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 57 participants
Interventions
- BIOLOGICAL: PIT565 — Study treatment will be provided in vials as open-label participant specific supply.
Primary Outcomes
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (6 months)
Secondary Outcomes
- Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax] (up to 6 months)
- Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC) (up to 6 months)
- Concentrations of anti-PIT565 antibodies (Baseline, up to 6 months)
Trial Locations
- Novartis Investigative Site, CABA, Argentina
- Novartis Investigative Site, Sofia, Bulgaria
- Novartis Investigative Site, Beijing, China
- Novartis Investigative Site, Beijing, China
- Novartis Investigative Site, Le Kremlin-Bicêtre, France
- Novartis Investigative Site, Jena, Thuringia, Germany
- Novartis Investigative Site, Mainz, Germany
- Novartis Investigative Site, Szeged, Hungary
- Novartis Investigative Site, Leiden, South Holland, Netherlands
- Novartis Investigative Site, Cluj-Napoca, Cluj, Romania
- ...and 3 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.