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NCT05886244: Soliris
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Phase 3 trial testing Eculizumab in Paroxysmal Nocturnal Hemoglobinuria in 25 participants. Completed in 14 April 2025.
14 April 2025
Quick facts
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 5 July 2023 |
| Primary completion | 14 April 2025 |
| Estimated completion | 14 April 2025 |
| Sites | 7 locations across China |
Drugs / interventions tested
- Eculizumab (ECULIZUMAB) — full drug profile →
Conditions studied
- Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →
Sponsor
Alexion Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (PNH) in China.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05886244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eculizumab
Trials testing the same drug.
- NCT06764160 — Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG · Phase 3 · completed
- NCT06513338 — Complement C5 mAb in the Treatment of Anti-GBM Disease · Phase 2 · completed
- NCT05876351 — Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China · Phase 3 · completed
- NCT05131204 — Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment · Phase 3 · terminated
- NCT05133531 — A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With · Phase 3 · recruiting
Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria
Currently open trials in the same condition.
- NCT07457151 — Danicopan PMS in Korea · recruiting
- NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
- NCT07470762 — Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 1, PHASE2 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07413679 — Long-term Safety of Danicopan: IPIG Registry-based Cohort Study · active not recruiting
Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06015750 — Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia · Phase 4 · withdrawn
- NCT07352423 — Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants · Phase 1 · recruiting
- NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab · Phase 4 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS · Phase 4 · 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 NCT05886244 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc.
- Last refreshed: 16 April 2025
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/NCT05886244.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing