A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works

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NCT05744921 · readout in 783 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

202estimated

Sites

Countries

Canada, Colombia, Hungary +16

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

2023-03-07

actual

When the study began enrolling

Primary completion

2028-10-10

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-10-10

estimated

The whole study's end, after follow-up

First posted

2023-02-27

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-30

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: Pozelimab — also filed as REGN3918
Drug: Cemdisiran — also filed as ALN-CC5

Primary outcomes

what the primary-completion date above is the date OF

Incidence of treatment-emergent serious adverse events (SAEs)

measured Up to week 108

Severity of treatment-emergent SAEs

measured Up to week 108

Incidence of treatment emergent adverse events of special interest (AESIs)

measured Up to week 108

Severity of treatment emergent AESIs

measured Up to week 108

Incidence of adverse events (AEs) leading to permanent treatment discontinuation

measured Up to week 108

Severity of adverse events (AEs) leading to permanent treatment discontinuation

measured Up to week 108

Percent change from baseline in lactate dehydrogenase (LDH)

measured Baseline to week 36

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