Actively Recruiting
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
Led by Novartis Pharmaceuticals · Updated on 2026-03-23
54
Participants Needed
13
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
CONDITIONS
Official Title
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of SLE according to the 2019 ACR/EULAR criteria
- Documentation of SLE autoantibodies
- Active SLE disease with SLEDAI-2K score of 4 or higher at screening
- Failure to respond to standard-of-care medicines for SLE treatment
- Immunization against pneumococcus, meningococcus, influenza, and COVID-19
You will not qualify if you...
- Severe SLE-related organ damage or life-threatening disease at screening
- Acute, severe lupus flare needing immediate treatment such as acute CNS lupus or catastrophic antiphospholipid syndrome
- Severe lupus kidney disease requiring immunosuppressive induction or maintenance treatment
- History or current ECG or cardiac abnormalities posing significant safety risk
- Use of prohibited medications defined in the protocol
- Active, significant infections including HIV, HBV, or HCV within one month prior to or during screening
- Serious medical illnesses likely to interfere with study participation
- Women of child-bearing potential not using highly effective contraception
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Novartis Investigative Site
Sofia, Bulgaria, 1612
Withdrawn
2
Novartis Investigative Site
Beijing, China, 100191
Actively Recruiting
3
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
4
Novartis Investigative Site
Berlin, Germany, 10117
Actively Recruiting
5
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
6
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
7
Novartis Investigative Site
Szeged, Hungary, 6725
Actively Recruiting
8
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 CL
Actively Recruiting
9
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
10
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
11
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
12
Novartis Investigative Site
Bern, Switzerland, 3010
Actively Recruiting
13
Novartis Investigative Site
Sankt Gallen, Switzerland, 9007
Withdrawn
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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