NCT05876351 (Soliris) is a Phase 3 clinical trial of Eculizumab in Atypical Hemolytic Uremic, sponsored by Alexion Pharmaceuticals, Inc..

Who is sponsoring NCT05876351?

NCT05876351 is sponsored by Alexion Pharmaceuticals, Inc..

What drugs are being tested in NCT05876351?

Interventions in NCT05876351: Eculizumab.

What condition does NCT05876351 study?

NCT05876351 studies Atypical Hemolytic Uremic.

Is NCT05876351 still recruiting?

NCT05876351 is currently completed. Last updated 8 December 2025.

Are results published for NCT05876351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-12-08 · How we verify

NCT05876351: Soliris

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China

Completed Phase 3 Results posted Last updated 8 December 2025

What this trial tests

Phase 3 trial testing Eculizumab in Atypical Hemolytic Uremic in 25 participants. Completed in 7 May 2025.

Timeline

14 July 2023

Primary endpoint
7 May 2025

7 May 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	14 July 2023
Primary completion	7 May 2025
Estimated completion	7 May 2025
Sites	6 locations across China

Drugs / interventions tested

Eculizumab (ECULIZUMAB) — full drug profile →

Conditions studied

Atypical Hemolytic Uremic — all drugs for Atypical Hemolytic Uremic →

Sponsor

Alexion Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 0 to 99, any sex, with Atypical Hemolytic Uremic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response Primary · Up to Week 26

The criteria for complete TMA response were: 1. Normalization of platelet count (defined as platelet count ≥ 150000/microliter (ul). 2. Normalization of lactate dehydrogenase (LDH, defined as LDH ≤ upper limit of normal \[ULN\]). 3. ≥ 25% improvement in serum creatinine from baseline.

Group	Value	95% CI
Eculizumab	64.0	42.5 – 82.0

Number of Participants With an Adverse Event (AE) Secondary · Up to Week 34

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: * resulted in death, * was life-threatening, * required inpatient hospitalization or prolongation of existing hospitalization, * resulted in persistent disability/incapacity, * was a congenital anomaly/birth defect, or * was an important medical event. A summary of all Serious Adverse Ev

Any AE

Group	Value	95% CI
Eculizumab	24

Any SAE

Group	Value	95% CI
Eculizumab	8

Mean Serum Concentration of Eculizumab Secondary · Pre-dose and post-dose at Days 1, 8, 29, 85, and 141; Pre-dose at Day 183

Day 1: Pre-dose

Group	Value	95% CI
Eculizumab	4.690	± 0.00

Day 1: Post-dose

Group	Value	95% CI
Eculizumab	373.423	± 47.59

Day 8: Pre-dose

Group	Value	95% CI
Eculizumab	153.190	± 69.69

Day 8: Post-dose

Group	Value	95% CI
Eculizumab	498.262	± 41.18

Day 29: Pre-dose

Group	Value	95% CI
Eculizumab	353.726	± 36.96

Day 29: Post-dose

Group	Value	95% CI
Eculizumab	727.862	± 32.22

Day 85: Pre-dose

Group	Value	95% CI
Eculizumab	360.070	± 43.89

Day 85: Post-dose

Group	Value	95% CI
Eculizumab	728.624	± 42.04

Change From Baseline in Serum Free Complement 5 (C5) Secondary · Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183

Day 1: Post-dose

Group	Value	95% CI
Eculizumab	-79.8842	± 17.5197

Day 8: Pre-dose

Group	Value	95% CI
Eculizumab	-79.6539	± 17.8589

Day 8: Post-dose

Group	Value	95% CI
Eculizumab	-79.6636	± 17.8610

Day 29: Pre-dose

Group	Value	95% CI
Eculizumab	-80.4277	± 17.1241

Day 29: Post-dose

Group	Value	95% CI
Eculizumab	-80.4284	± 17.1241

Day 85: Pre-dose

Group	Value	95% CI
Eculizumab	-80.0632	± 17.3489

Day 85: Post-dose

Group	Value	95% CI
Eculizumab	-80.0632	± 17.3489

Day 141: Pre-dose

Group	Value	95% CI
Eculizumab	-80.0625	± 17.3485

Change From Baseline in Serum Total C5 Secondary · Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183

Day 1: Post-dose

Group	Value	95% CI
Eculizumab	-12.0267	± 6.1396

Day 8: Pre-dose

Group	Value	95% CI
Eculizumab	37.9293	± 21.3162

Day 8: Post-dose

Group	Value	95% CI
Eculizumab	40.2831	± 23.0175

Day 29: Pre-dose

Group	Value	95% CI
Eculizumab	65.9100	± 25.0734

Day 29: Post-dose

Group	Value	95% CI
Eculizumab	64.4783	± 22.7695

Day 85: Pre-dose

Group	Value	95% CI
Eculizumab	71.2418	± 25.7350

Day 85: Post-dose

Group	Value	95% CI
Eculizumab	66.5267	± 26.7232

Day 141: Pre-dose

Group	Value	95% CI
Eculizumab	71.8284	± 25.3689

Number of Participants With an Anti-drug Antibody (ADA) Response Secondary · Up to Week 26

An ADA response was defined as a positive ADA sample at any time during the study.

Group	Value	95% CI
Eculizumab	0

Time to Complete TMA Response Secondary · Up to Week 26

Time to complete TMA response was defined as the time from first infusion to the first time point at which all criteria for complete TMA response was met. The criteria for complete TMA response were: 1. Normalization of platelet count (defined as platelet count ≥ 150000/ul. 2. Normalization of LDH, defined as LDH ≤ ULN). 3. ≥ 25% improvement in serum creatinine from baseline. Participants who did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed.

Group	Value	95% CI
Eculizumab	75.0	22.0 – NA

Proportion of Participants On or Off Dialysis at Each Timepoint Secondary · Baseline and Days 22, 43, 71, 99, 113, 127, 155 and 183

Participants were considered as 'off' dialysis at a specific time point if they were dialysis free for more than 5 days prior to that time point. Participants were considered as 'on' dialysis at a specific time point if they were dialysis free to 5 days or less up prior to that time point.

Baseline: On Dialysis

Group	Value	95% CI
Eculizumab	0.440	0.244 – 0.651

Baseline: Off Dialysis

Group	Value	95% CI
Eculizumab	0.560	0.349 – 0.756

Day 22: On Dialysis

Group	Value	95% CI
Eculizumab	0.261	0.102 – 0.484

Day 22: Off Dialysis

Group	Value	95% CI
Eculizumab	0.739	0.516 – 0.898

Day 43: On Dialysis

Group	Value	95% CI
Eculizumab	0.235	0.068 – 0.499

Day 43: Off Dialysis

Group	Value	95% CI
Eculizumab	0.765	0.501 – 0.932

Day 71: On Dialysis

Group	Value	95% CI
Eculizumab	0.211	0.061 – 0.456

Day 71: Off Dialysis

Group	Value	95% CI
Eculizumab	0.789	0.544 – 0.939

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Each Scheduled Visit Secondary · Baseline, Days 22, 43, 71, 99, 113, 127, 155 and 183

Expressed in milliliters per minute per 1.73 square meters of body surface area.

Day 22

Group	Value	95% CI
Eculizumab	39.82	± 50.83

Day 43

Group	Value	95% CI
Eculizumab	32.72	± 44.75

Day 71

Group	Value	95% CI
Eculizumab	40.33	± 47.38

Day 99

Group	Value	95% CI
Eculizumab	37.53	± 47.17

Day 113

Group	Value	95% CI
Eculizumab	35.88	± 45.38

Day 127

Group	Value	95% CI
Eculizumab	35.85	± 48.01

Day 155

Group	Value	95% CI
Eculizumab	43.33	± 49.32

Day 183

Group	Value	95% CI
Eculizumab	36.29	± 44.21

Proportion of Participants With a Chronic Kidney Disease (CKD) Stage Shift Categorized as "Improved", "Stable", or "Worsened" at Each Scheduled Visit Compared to Baseline Secondary · Baseline to Days 22, 43, 71, 99, 113, 127, 155 and 183

CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage where Stage 5 represents the most severe disease and Stage 1 represents the least severe disease. "Improved" excluded participants with Stage 1 at baseline as there was no room for improvement. "Worsened" excludes participants with Stage 5 at baseline as there was no room to worsen.

Day 22: Improved

Group	Value	95% CI
Eculizumab	0.545	0.322 – 0.756

Day 22: Stable

Group	Value	95% CI
Eculizumab	0.455	0.244 – 0.678

Day 22: Worsened

Group	Value	95% CI
Eculizumab	0	0 – 0.410

Day 43: Improved

Group	Value	95% CI
Eculizumab	0.688	0.413 – 0.890

Day 43: Stable

Group	Value	95% CI
Eculizumab	0.313	0.110 – 0.587

Day 43: Worsened

Group	Value	95% CI
Eculizumab	0	0 – 0.602

Day 71: Improved

Group	Value	95% CI
Eculizumab	0.722	0.465 – 0.903

Day 71: Stable

Group	Value	95% CI
Eculizumab	0.278	0.097 – 0.535

Change From Baseline in Platelets Secondary · Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183

Platelet values obtained from the day of a blood transfusion of platelets through 3 days after the transfusion are excluded from all analysis.

Day 22

Group	Value	95% CI
Eculizumab	76.5	± 117.7

Day 43

Group	Value	95% CI
Eculizumab	65.5	± 90.1

Day 71

Group	Value	95% CI
Eculizumab	71.3	± 97.9

Day 99

Group	Value	95% CI
Eculizumab	79.4	± 68.1

Day 113

Group	Value	95% CI
Eculizumab	60.1	± 82.7

Day 127

Group	Value	95% CI
Eculizumab	61.8	± 86.1

Day 155

Group	Value	95% CI
Eculizumab	76.8	± 98.2

Day 183

Group	Value	95% CI
Eculizumab	80.3	± 98.0

Change From Baseline in LDH Secondary · Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183

Day 22

Group	Value	95% CI
Eculizumab	-9.445	± 12.459

Day 43

Group	Value	95% CI
Eculizumab	-6.147	± 10.175

Day 71

Group	Value	95% CI
Eculizumab	-7.083	± 10.099

Day 99

Group	Value	95% CI
Eculizumab	-5.861	± 8.356

Day 113

Group	Value	95% CI
Eculizumab	-5.769	± 8.041

Day 127

Group	Value	95% CI
Eculizumab	-5.444	± 8.314

Day 155

Group	Value	95% CI
Eculizumab	-5.848	± 8.478

Day 183

Group	Value	95% CI
Eculizumab	-5.680	± 8.172

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 34. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Eculizumab

Serious: 8/25 (32%)

Deaths: 0/25

Serious adverse events (9 terms)

Reaction	System	Eculizumab
Pneumonia	Infections and infestations	—
Bacterial infection	Infections and infestations	—
Clostridium difficile infection	Infections and infestations	—
Infection	Infections and infestations	—
Rotavirus infection	Infections and infestations	—
Retching	Gastrointestinal disorders	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—
Hepatic function abnormal	Hepatobiliary disorders	—
Synovial cyst	Musculoskeletal and connective tissue disorders	—

Other adverse events (17 terms — click to expand)

Reaction	System	Eculizumab
Hyperkalaemia	Metabolism and nutrition disorders	—
Upper respiratory tract infection	Infections and infestations	—
Vomiting	Gastrointestinal disorders	—
Respiratory tract infection	Infections and infestations	—
Hepatic function abnormal	Hepatobiliary disorders	—
Infection	Infections and infestations	—
Hyperphosphataemia	Metabolism and nutrition disorders	—
Pyrexia	General disorders	—
Bronchitis	Infections and infestations	—
Influenza	Infections and infestations	—
Anaemia	Blood and lymphatic system disorders	—
Leukopenia	Blood and lymphatic system disorders	—
Electrolyte imbalance	Metabolism and nutrition disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—
Hypertension	Vascular disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Diarrhoea	Gastrointestinal disorders	—

Most-reported serious reactions: Pneumonia, Bacterial infection, Clostridium difficile infection, Infection, Rotavirus infection, Retching, Upper gastrointestinal haemorrhage, Hepatic function abnormal.

Data from ClinicalTrials.gov NCT05876351 adverse events section.

Sponsor's own description

This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) 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:

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
NCT05886244 — Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) 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 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05876351 (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: 8 December 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/NCT05876351.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05876351: Soliris

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Eculizumab

Other Alexion Pharmaceuticals, Inc. trials

Verify against primary sources