Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.

Part of paid clinical trials in Duarte, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05630001
Phase
PHASE3
Status
Completed

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

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

Interventions

  • Iptacopan — DRUG
    Treatment with iptacopan at a dose of 200 mg b.i.d. will start on the first day (Day 1) and continue for 24 weeks.

Study Details

The purpose of the study was to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switched from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.

Key Dates

Start date
Apr 24, 2023
Status verified
Dec 2025
Primary completion
Oct 17, 2024
Completion
Oct 17, 2024

Study Design

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

Arms

  • Experimental: LNP023 200mg b.i.d.
    Iptacopan (LNP023) at a dose of 200 mg b.i.d. orally

Primary Outcome Measure

Change in Hb Levels as Mean of Visits Between Day 126 and Day 168 Compared to Baseline Tested for Non-inferiority [ Time Frame: Baseline, Day 126 to Day 168 ]

Locations (9)

FacilityCityStateZIPSite coordinators
City Of Hope National Med CenterDuarteCalifornia91010-
USC Norris Cancer CenterLos AngelesCalifornia90033-
Lakes ResearchMiami LakesFlorida33014-
Mass Gen Hosp Cancer CenterBostonMassachusetts02114-
University Of MinnesotaMinneapolisMinnesota55455-
Montefiore Medical CenterThe BronxNew York10461-
Cleveland Clinic FoundationClevelandOhio44195-
Prisma Health UpstateGreenvilleSouth Carolina29615-
Huntsman Cancer Institute Univ of UtahSalt Lake CityUtah84112 0550-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City Of Hope National Med Center· Duarte, CAUSC Norris Cancer Center· Los Angeles, CALakes Research· Miami Lakes, FLMass Gen Hosp Cancer Center· Boston, MAUniversity Of Minnesota· Minneapolis, MNMontefiore Medical Center· The Bronx, NY

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