Cemdisiran
Sponsors
Regeneron Pharmaceuticals Inc., Alnylam Pharmaceuticals, Mario Negri Institute for Pharmacological Research, Regeneron Pharmaceuticals
Conditions
Age-related Macular Degeneration (AMD)Atypical Hemolytic Uremic SyndromeBerger DiseaseGeneralized Myasthenia GravisGeographic Atrophy (GA)Geographic Atrophy Secondary to Age-Related Macular DegenerationGlomerulonephritis, IgAHealthy
Phase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
CompletedNCT04601844
Start: 2020-11-16End: 2021-07-23Updated: 2021-11-12
A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers
CompletedNCT04940364
Start: 2021-08-04End: 2022-06-22Updated: 2022-07-06
Phase 2
A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome
WithdrawnNCT03303313
Start: 2017-09-19End: 2018-09-12Updated: 2018-10-01
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
TerminatedNCT03841448
Start: 2019-09-30End: 2023-06-27Updated: 2024-08-09
Eculizumab to Cemdisiran Switch in aHUS
WithdrawnNCT03999840
Start: 2021-01-31End: 2024-03-31Updated: 2021-03-10
Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
CompletedNCT04811716
Start: 2021-07-29End: 2023-10-18Updated: 2025-04-08
Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy
CompletedNCT04888507
Start: 2021-07-08End: 2023-05-04Updated: 2025-08-29
Phase 3
A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
Active, not recruitingNCT05070858
Start: 2021-12-14End: 2028-11-11Updated: 2026-02-12
Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
TerminatedNCT05131204
Start: 2022-10-06End: 2023-07-12Updated: 2025-04-08
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
RecruitingNCT05133531
Start: 2022-08-01End: 2027-01-28Target: 190Updated: 2026-02-24
A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works
RecruitingNCT05744921
Start: 2023-03-07End: 2029-02-26Target: 202Updated: 2026-03-18
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
RecruitingNCT06541704
Start: 2024-10-30End: 2032-05-21Target: 975Updated: 2026-03-23
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
RecruitingCTIS2023-510336-36-00
Start: 2023-05-05Target: 17Updated: 2025-11-04
A Randomized, Open-Label, C5 Inhibitor-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy
RecruitingCTIS2023-509657-31-00
Start: 2022-08-24Target: 17Updated: 2025-11-10
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration
RecruitingCTIS2023-509547-27-00
Start: 2025-05-22Target: 464Updated: 2026-01-19
A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently
RecruitingNCT07154745
Start: 2026-03-31End: 2031-09-23Target: 35Updated: 2026-03-19
A Single Arm Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria with Inadequate Control of Intravascular Hemolysis on Currently Available C5 Inhibitor Therapy
Not yet recruitingCTIS2024-519709-37-00
Target: 8Updated: 2025-11-28