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

NCT03593200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-12-22

Study results available
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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

  • PNH

Interventions

DRUG

Pegcetacoplan

Complement (C3) Inhibitor

Sponsors & Collaborators

  • Apellis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Federico Grossi, MD, PhD · Study Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2019-10-22
Completion
2019-10-22
FDA Drug
Yes

Countries

  • Bulgaria
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593200 on ClinicalTrials.gov