A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
← catalyst calendarNCT05133531 · readout in 53 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
202actual
Sites
68
Countries
Brazil, Canada, China +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-01 | actual | When the study began enrolling |
| Primary completion | 2026-10-12 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-26 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Paroxysmal Nocturnal Hemoglobinuria
Interventions
- Drug: Ravulizumab — also filed as ALXN1210, Ultomiris
- Drug: Pozelimab — also filed as REGN3918
- Drug: Cemdisiran — also filed as ALN-CC5
- Drug: Eculizumab — also filed as Soliris
Primary outcomes
what the primary-completion date above is the date OFPercent change in lactate dehydrogenase (LDH)
measured From baseline to week 26
Transfusion avoidance
measured From post-baseline day 1 through week 26
Adequate control of hemolysis
measured From week 8 through week 26, inclusive
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