Last reviewed · How we verify
NCT06335979
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
Phase 1 trial testing PIT565 in Systemic Lupus Erythematosus, SLE in 54 participants. Currently enrolling.
9 July 2027
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 8 October 2024 |
| Primary completion | 9 July 2027 |
| Estimated completion | 9 July 2027 |
| Sites | 13 locations across Netherlands, Germany, Hungary, Switzerland, Bulgaria, China, Spain |
Drugs / interventions tested
- PIT565 — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus, SLE — all drugs for Systemic Lupus Erythematosus, SLE →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 75, any sex, with Systemic Lupus Erythematosus, SLE. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Molecule Formats of B-Cell Targeting Biologics: Applications in Autoimmune Disease Treatment and Impacts on Manufacturability.
Qian Y, Mahmoud TI. · · 2025 · PMID 40284490 · DOI 10.3390/pharmaceutics17040495
Verify or expand the search:
- PubMed search for NCT06335979
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PIT565
Trials testing the same drug.
- NCT07029555 — An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT05397496 — Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies · Phase 1 · active not recruiting
Other recruiting trials for Systemic Lupus Erythematosus, SLE
Currently open trials in the same condition.
- NCT05688696 — Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus · Phase 2 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06335979 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 23 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06335979.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing