Managed Access Programs for LNP023, Iptacopan

Status Available

Clinical Trial Summary

The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan

Clinical Trial Description

- CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys. - CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH). ;

Study Design

Related Conditions & MeSH terms

C3 Glomerulopathy (C3G)
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Paroxysmal Nocturnal Hemoglobinuria (PNH)

Clinical Trial Details

NCT number	NCT05222412
Study type	Expanded Access
Source	Novartis
Contact	MAP requests are initiated by a licensed physician.https:// www.
Phone	1-888-669-6682
Email	novartis.email@novartis.com
Status	Available
Phase

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00004143` - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Phase 2
Terminated	`NCT05116787` - BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy	Phase 2
Recruiting	`NCT06294301` - A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants	Phase 1
Completed	`NCT03472885` - Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab	Phase 2
Completed	`NCT03946748` - Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Phase 2
Enrolling by invitation	`NCT03427060` - Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms	Phase 2
Completed	`NCT03078582` - Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients	Phase 2
Completed	`NCT03053102` - Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Phase 2
Not yet recruiting	`NCT06312644` - Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Completed	`NCT03588026` - Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576	Phase 3
Completed	`NCT03056040` - ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	Phase 3
Completed	`NCT00145613` - Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies	Phase 2
Completed	`NCT00587054` - Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders	Phase 2
Recruiting	`NCT05876312` - Safety, Tolerability, PK and PD of ADX-038 in HV and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients	Phase 1
Completed	`NCT04820530` - Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy	Phase 3
Terminated	`NCT03225287` - Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study	Phase 2
Completed	`NCT04558918` - Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment	Phase 3
Completed	`NCT02352493` - A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH	Phase 1/Phase 2
Recruiting	`NCT04901936` - A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Phase 2
Completed	`NCT02264639` - A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH	Phase 1