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Trials / Completed

CompletedNCT03593200

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH

Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH).

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Apellis Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase IIa, open-label, multiple dose, study in patients with PNH who have not received eculizumab (Soliris ®) in the past. A single cohort of subjects is planned for evaluation.

Conditions

Interventions

TypeNameDescription
DRUGPegcetacoplanComplement (C3) Inhibitor

Timeline

Start date
2018-08-16
Primary completion
2019-10-22
Completion
2019-10-22
First posted
2018-07-20
Last updated
2020-12-22
Results posted
2020-12-22

Locations

3 sites across 2 countries: Bulgaria, Serbia

Regulatory

Source: ClinicalTrials.gov record NCT03593200. Inclusion in this directory is not an endorsement.

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL (NCT03593200) · Clinical Trials Directory