Last reviewed · How we verify
NCT05141201
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
trial in Lupus Erythematosus, Systemic in 1,620 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2027
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,620 |
| Start date | 21 December 2021 |
| Primary completion | 31 March 2027 |
| Estimated completion | 31 March 2027 |
| Sites | 47 locations across Japan |
Conditions studied
- Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
Sponsor
AstraZeneca — full company profile →
Who can join
Eligibility, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interferon Inhibition in SLE: From Bench to Bedside.
Deligeorgakis D, Skouvaklidou E, Adamichou C. · · 2024 · cited 3× · PMID 39193183 · DOI 10.31138/mjr.010324.iis
Verify or expand the search:
- PubMed search for NCT05141201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
- NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
- NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
- NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
- NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
- NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · 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 NCT05141201 (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 AstraZeneca
- Last refreshed: 19 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/NCT05141201.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing