A Multicenter, Single-arm, Open Label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult aHUS Patients Who Are Naive to Complement Inhibitor Therapy

Who is this study for? Adults with atypical hemolytic uremic syndrome who are treatment naive to complement inhibitor therapy
What treatments are being studied? Iptacopan
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Adult patients with evidence of active thrombotic microangiopathy (TMA), including thrombocytopenia, evidence of hemolysis, and acute kidney injury

• Vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections are required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination or before vaccination is given, prophylactic antibiotic treatment must be administered at the start of study treatment and for at least 2 weeks after vaccination

Locations
United States
Alabama
Uni Of Alabama At Birmingham
RECRUITING
Birmingham
California
Univ of California at Los Angeles
RECRUITING
Los Angeles
USC Norris Cancer Center
RECRUITING
Los Angeles
Univ Cali Irvine ALS Neuromuscular
RECRUITING
Orange
Harbor-UCLA Medical Center .
RECRUITING
Torrance
Washington, D.c.
Georgetown University Lombardi Cancer Center
RECRUITING
Washington D.c.
Florida
University Of Miami
RECRUITING
Miami
Massachusetts
Brigham and Womens Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
WA Uni School Of Med
RECRUITING
St Louis
North Carolina
Duke University Medical Center
RECRUITING
Durham
New Jersey
Rut Univ for Translational Med Scie
RECRUITING
New Brunswick
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Montefiore Medical Center .
RECRUITING
The Bronx
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Comprehensive Transplant Ctr at OSU
RECRUITING
Columbus
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Baylor Scott and White Research
RECRUITING
Temple
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Austria
Novartis Investigative Site
RECRUITING
Innsbruck
Novartis Investigative Site
RECRUITING
Vienna
Brazil
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
RECRUITING
Botucatu
Novartis Investigative Site
RECRUITING
Brasília
Novartis Investigative Site
RECRUITING
Fortaleza
Novartis Investigative Site
RECRUITING
Pernambuco
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
Rio De Janeiro
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Nanjing
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanxi
Novartis Investigative Site
RECRUITING
Yantai
Greece
Novartis Investigative Site
RECRUITING
Athens
Novartis Investigative Site
RECRUITING
Heraklion Crete
Novartis Investigative Site
RECRUITING
Thessaloniki
India
Novartis Investigative Site
RECRUITING
Chandigarh
Novartis Investigative Site
RECRUITING
Chennai
Novartis Investigative Site
RECRUITING
Hyderabad
Novartis Investigative Site
RECRUITING
Lucknow
Novartis Investigative Site
RECRUITING
Nagpur
Novartis Investigative Site
RECRUITING
Pune
Novartis Investigative Site
RECRUITING
Thiruvananthapuram
Novartis Investigative Site
RECRUITING
Vellore
Japan
Novartis Investigative Site
RECRUITING
Bunkyo Ku
Novartis Investigative Site
RECRUITING
Iruma-gun
Novartis Investigative Site
RECRUITING
Izumo
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Martin
Slovenia
Novartis Investigative Site
RECRUITING
Ljubljana
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taoyuan District
United Kingdom
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-01-17
Estimated Completion Date: 2029-03-29
Participants
Target number of participants: 50
Treatments
Experimental: Iptacopan 200 mg b.i.d
Single arm open-label with 50 adult patients receiving 200mg oral twice daily doses of iptacopan
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov