Clinical trials: sponsored by Alexion Pharmaceuticals, Inc.
Transthyretin Amyloid Cardiomyopathy
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total…
- Trial name
- DepleTTR-CM (NCT06183931)
- Testing
- ALXN2220
- Where
- 213 sites in United States, Argentina and 25 more
- Volunteers
- 1,182 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis, gMG
Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)
The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized…
- Trial name
- NCT07596784
- Testing
- Ravulizumab
- Where
- 10 sites in China
- Volunteers
- 20 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder, NMOSD
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT).
- Conditions
- Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
- Trial name
- NCT05966467
- Where
- 33 sites in United States, Argentina and 6 more
- Volunteers
- 200 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Immunoglobulin A Nephropathy, IgAN
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.
- Trial name
- I CAN (NCT06291376)
- Testing
- Ravulizumab
- Where
- 246 sites in United States, Argentina and 26 more
- Volunteers
- 584 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
NMOSD, Neuromyelitis Optica Spectrum Disorder
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab)…
- Trial name
- NCT07557420
- Testing
- Ravulizumab
- Where
- 10 sites in China
- Volunteers
- 19 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypophosphatasia (HPP)
Registry of Patients With Hypophosphatasia
In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.
- Trial name
- NCT02306720
- Where
- 66 sites in United States, Australia and 10 more
- Volunteers
- 1,571 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
BAG3 Mutation Associated Dilated Cardiomyopathy
ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy
This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM.
- Trial name
- DCMRestore (NCT07218887)
- Testing
- ALXN2350
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy
The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study…
- Trial name
- LTSAFE-ALXN (NCT07789483)
- Testing
- ALXN2220
- Where
- 195 sites in United States, Argentina and 25 more
- Volunteers
- 1,180 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Antibody-Mediated Rejection, Kidney Transplantation
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
- Conditions
- Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores, AMR
- Trial name
- CONCORD (NCT06744647)
- Testing
- ALXN2030
- Where
- 51 sites in United States, Brazil and 6 more
- Volunteers
- 47 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Acromegaly
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog…
- Trial name
- ASTERIA (NCT07037420)
- Testing
- ALXN2420
- Where
- 6 sites in United States, Italy and 2 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
IgAN, IgAVN
Study of Ravulizumab in Pediatric Participants With Primary IgAN
The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or…
- Conditions
- IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis
- Trial name
- NCT07024563
- Testing
- Ravulizumab
- Where
- 15 sites in United States, China and 5 more
- Volunteers
- 36 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Thrombotic Microangiopathy, Hematopoietic Stem Cell Transplant
A Study Using Real-world Data to Examine Outcomes in Children and Adults Who Develop a Blood Clotting Disorder Called Thrombotic Microangiopathy (TMA) After Undergoing a Hematopoietic Stem Cell Transplant (HSCT).
The purpose of this study was to assess OS outcomes in pediatric (≥ 28 days of age at the time of HSCT-TMA diagnosis) and adult participants diagnosed with HSCT-TMA(referred to as TMA from hereon) within 52 weeks after HSCT and…
- Trial name
- ALX-TMA-502 (NCT07732361)
- Where
- 43 sites in United States, Belgium and 8 more
- Volunteers
- 307 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Kidney Disease, CKD
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who…
- Conditions
- Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
- Trial name
- ARTEMIS (NCT05746559)
- Testing
- Ravulizumab
- Where
- 130 sites in United States, Argentina and 18 more
- Volunteers
- 555 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants
This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in healthy adult participants.
- Trial name
- NCT04933682
- Testing
- ALXN2050, Fluconazole, Rifampin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Relapsed AL Amyloidosis, Refractory AL Amyloidosis
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
- Conditions
- Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis, Amyloidosis
- Trial name
- ALACRITY (NCT07081646)
- Testing
- AZD0120
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 91 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04504825
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
- Where
- 90 sites in United States, Australia and 17 more
- Volunteers
- 125 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemoglobinuria
Paroxysmal Nocturnal Hemoglobinuria (PNH), Level of CD59 on Red and White Blood Cells in Bone Marrow Failure Syndromes
Examine red and white blood cells of PNH patients with bone marrow failure syndromes.
- Trial name
- EXPLORE (NCT01192425)
- Volunteers
- 5,580 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myocardial Infarction
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
- Trial name
- ERASE-MI (NCT00546260)
- Testing
- PRT060128 Potassium
- Where
- 31 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
- Trial name
- NCT05346354
- Testing
- Ravulizumab
- Where
- 16 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypophosphatasia
Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa
The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.
- Trial name
- HICKORY (NCT06079281)
- Testing
- ALXN1850
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 124 people
- Sponsor
- Alexion Pharmaceuticals, Inc.