A Phase Ib, Open-label, Ascending Dose Study With Step-up Doses to Assess Safety, Tolerability, and Pharmacokinetics of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
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 SLE
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosis of SLE according to the 2019 ACR/EULAR criteria
• Documentation of SLE autoantibodies
• Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening
• Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol
• Immunization against pneumococcus, meningococcus, influenza, and COVID-19
Locations
Other Locations
Bulgaria
Novartis Investigative Site
WITHDRAWN
Sofia
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Mainz
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Szeged
Netherlands
Novartis Investigative Site
RECRUITING
Leiden
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Santiago Compostela
Switzerland
Novartis Investigative Site
RECRUITING
Bern
Novartis Investigative Site
RECRUITING
Sankt Gallen
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2027-07-09
Participants
Target number of participants: 54
Treatments
Experimental: Cohort 1
Dose level 1
Experimental: Cohort 2
Dose level 2
Experimental: Cohort 3
Dose level 3
Experimental: Cohort 4
Dose level 4
Experimental: Cohort 5
Dose level 5
Experimental: Cohort 6
Dose level 6
Experimental: Cohort 7
Dose level 7
Experimental: Cohort 8
Dose level 8
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals