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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04889430
Phase
PHASE3
Status
Completed

Conditions

  • Atypical Hemolytic Uremic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Iptacopan — DRUG
    Iptacopan 200mg twice daily oral

Study Details

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.

Key Dates

Start date
Jan 17, 2022
Status verified
May 2026
Primary completion
Apr 11, 2026
Completion
Apr 11, 2026

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan 200 mg b.i.d
    Single arm open-label with 50 adult patients receiving 200mg oral twice daily doses of iptacopan

Primary Outcome Measure

Percentage of participants with complete TMA response without the use of PE/PI and anti-C5 antibody [ Time Frame: 26 weeks of study treatment ]

Locations (16)

FacilityCityStateZIPSite coordinators
Univ of California at Los AngelesLos AngelesCalifornia90095-
USC Norris Cancer CenterLos AngelesCalifornia90033-
Univ Cali Irvine ALS NeuromuscularOrangeCalifornia92868-
Univ of California at SacramentoSacramentoCalifornia95817-
Harbor-UCLA Medical Center .TorranceCalifornia90502-
Georgetown University Lombardi Cancer CenterWashington D.C.District of Columbia20007-2197-
University Of MiamiMiamiFlorida33136-
University of MinnesotaMinneapolisMinnesota55455-
Montefiore Medical CenterThe BronxNew York10461-
Montefiore Medical Center .The BronxNew York10461-
Duke University Medical CenterDurhamNorth Carolina27710-
University of CincinnatiCincinnatiOhio45267-0585-
Cleveland Clinic FoundationClevelandOhio44195-
Comprehensive Transplant Ctr at OSUColumbusOhio43210-
UT Southwestern Medical CenterDallasTexas75390-
Virginia Commonwealth UniversityRichmondVirginia23298-

Related coverage on Hipa.ai

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By research site
Univ of California at Los Angeles· Los Angeles, CAUSC Norris Cancer Center· Los Angeles, CAUniv Cali Irvine ALS Neuromuscular· Orange, CAUniv of California at Sacramento· Sacramento, CAHarbor-UCLA Medical Center .· Torrance, CAGeorgetown University Lombardi Cancer Center· Washington D.C., DC

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