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A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

NCT05096403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-30

Study results available
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Summary

The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).

Conditions

  • Cold Agglutinin Disease

Interventions

DRUG

Pegcetacoplan

Pegcetacoplan taken twice weekly as subcutaneous injection

DRUG

Placebo matching Pegcetacoplan

Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Study physician · Swedish Orphan Biovitrum AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2024-05-27
Completion
2024-09-11
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Finland
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

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 NCT05096403 on ClinicalTrials.gov