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Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease

NCT03157037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-07

Study results available
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Summary

This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).

Conditions

  • Anti-Glomerular Basement Membrane Antibody Disease

Interventions

BIOLOGICAL

Imlifidase

One dose of 0.25 mg/kg body weight imlifidase on study day 1

Sponsors & Collaborators

  • Hansa Biopharma AB

    collaborator INDUSTRY

  • Mårten Segelmark

    lead OTHER_GOV

Principal Investigators

  • Mårten Segelmark, MD PhD Prof · Linkoeping University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2020-07-24
Completion
2020-07-24

Countries

  • Austria
  • Czechia
  • Denmark
  • France
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT03157037 on ClinicalTrials.gov