Testing PIT565 for treating systemic lupus erythematosus
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).
This study is testing a new treatment called PIT565 to see if it can safely reduce B cells in people with systemic lupus erythematosus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 13 sites (Sofia and 12 other locations) |
| Trial ID | NCT06335979 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of PIT565 in individuals diagnosed with systemic lupus erythematosus (SLE). It is an open-label, ascending dose study where participants will receive subcutaneous doses of PIT565. The study will consist of up to 8 cohorts, with each cohort starting with 3 sentinel participants, and may include additional participants based on safety and biological activity results. The goal is to identify a safe dose that effectively depletes B cells in participants.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with SLE who have active disease and have not responded to standard-of-care medications.
Not a fit: Patients with severe organ damage or life-threatening conditions related to SLE may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with systemic lupus erythematosus who have not responded to standard treatments.
How similar studies have performed: Other studies have shown promise with similar approaches targeting B cell depletion in SLE, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sofia and 12 other locations
- Novartis Investigative Site — Sofia, Bulgaria (Withdrawn)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Berlin, Germany (Recruiting)
- Novartis Investigative Site — Mainz, Germany (Recruiting)
- Novartis Investigative Site — Budapest, Hungary (Recruiting)
- Novartis Investigative Site — Szeged, Hungary (Recruiting)
- Novartis Investigative Site — Leiden, South Holland, Netherlands (Recruiting)
- Novartis Investigative Site — Santiago Compostela, A Coruna, Spain (Recruiting)
- Novartis Investigative Site — Barcelona, Spain (Recruiting)
- Novartis Investigative Site — Madrid, Spain (Recruiting)
- Novartis Investigative Site — Bern, Switzerland (Recruiting)
- Novartis Investigative Site — Sankt Gallen, Switzerland (Withdrawn)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.