NCT06335979 An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
| NCT ID | NCT06335979 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Systemic Lupus Erythematosus, SLE |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2027-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 54 participants in total. It began in 2024-10-08 with a primary completion date of 2027-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe SLE-related organ damage dysfunction or life-threatening disease at screening. * Any acute, severe lupus-related flare during screening that needs immediate treatment such as acute CNS lupus (e.g., psychosis, epilepsy) or catastrophic antiphospholipid syndrome. * Presence of severe lupus kidney disease as defined by worsening proteinuria or estimated glomerular filtration rate (eGFR) which in the opinion of the Investigator requires immunosuppressive induction or maintenance treatment at screening. * History or current diagnosis of ECG or cardiac abnormalities indicating a significant risk of safety for participants. * Use of prohibited medication defined in the protocol. * Clinically significant active, opportunistic, chronic or recurrent infection (including, HIV, HBV, HCV) confirmed one month prior to or during screening. * Serious medical illness likely to interfere with participation in this clinical study. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception Other protocol defined inclusion/exclusion criteria may apply.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06335979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Systemic Lupus Erythematosus, SLE. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06335979 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06335979 currently recruiting?
Yes, NCT06335979 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06335979 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Beijing, China, Beijing, China, Berlin, Germany and 9 additional locations.
Who is sponsoring the NCT06335979 clinical trial?
NCT06335979 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 54 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.