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Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy

NCT04889430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.

Conditions

  • Atypical Hemolytic Uremic Syndrome

Interventions

DRUG

Iptacopan

Iptacopan 200mg twice daily oral

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2026-04-11
Completion
2026-04-11
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • China
  • Czechia
  • India
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04889430 on ClinicalTrials.gov