A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed informed consent must be obtained prior to participation in the study. Male and female patients, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior to screening.
• Immunization (primary or from vaccinations) against pneumococcus, influenza, meningococcus and COVID-19 infection at least 2 weeks prior to the first dosing. Local guidelines should be followed to determine requirement for vaccination (or booster), as well as the type and schedule of vaccination.
Locations
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Bulgaria
Novartis Investigative Site
RECRUITING
Sofia
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
France
Novartis Investigative Site
RECRUITING
Brest
Novartis Investigative Site
RECRUITING
Le Kremlin-bicêtre
Novartis Investigative Site
RECRUITING
Paris
Germany
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
RECRUITING
Mainz
Hungary
Novartis Investigative Site
RECRUITING
Szeged
Netherlands
Novartis Investigative Site
RECRUITING
Leiden
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Cluj-napoca
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Santiago Compostela
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2028-05-16
Participants
Target number of participants: 57
Treatments
Experimental: PIT565 dose 1
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 2
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 3
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 4
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 5
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 6
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 7
Study treatment will be provided in vials as open-label participant specific supply.
Experimental: PIT565 dose 8
Study treatment will be provided in vials as open-label participant specific supply.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals