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Last Updated: May 15, 2024

CLINICAL TRIALS PROFILE FOR ALXN2050


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Clinical Trials for ALXN2050

Trial ID Title Status Sponsor Phase Summary
NCT04170023 ↗ Proof of Concept Study of ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Recruiting Achillion Pharmaceuticals Phase 2 The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still experience anemia and reticulocytosis, or patients currently treated with ALXN2040 (danicopan) as monotherapy. After signing consent, participants will have periodic visits through Week 12, at which time the primary endpoint and key secondary assessments will be analyzed. Participants will continue on treatment past 12 weeks into a long-term extension portion of the trial.
NCT04170023 ↗ Proof of Concept Study of ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Recruiting Alexion Pharmaceuticals Phase 2 The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still experience anemia and reticulocytosis, or patients currently treated with ALXN2040 (danicopan) as monotherapy. After signing consent, participants will have periodic visits through Week 12, at which time the primary endpoint and key secondary assessments will be analyzed. Participants will continue on treatment past 12 weeks into a long-term extension portion of the trial.
NCT04551586 ↗ A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants Enrolling by invitation Celerion Phase 1 This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
NCT04551586 ↗ A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants Enrolling by invitation Alexion Pharmaceuticals Phase 1 This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
NCT04609670 ↗ Study of Radiolabeled ALXN2050 in Healthy Adult Males Not yet recruiting Celerion Phase 1 This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
NCT04609670 ↗ Study of Radiolabeled ALXN2050 in Healthy Adult Males Not yet recruiting Alexion Pharmaceuticals Phase 1 This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for ALXN2050

Condition Name

Condition Name for
Intervention Trials
Healthy 11
IgAN 1
Immunoglobulin A Nephropathy 1
Impaired Hepatic Function 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Lupus Nephritis 1
Kidney Diseases 1
Glomerulonephritis, IGA 1
Renal Insufficiency 1
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Clinical Trial Locations for ALXN2050

Trials by Country

Trials by Country for
Location Trials
United States 10
New Zealand 3
United Kingdom 2
Korea, Republic of 1
Italy 1
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Trials by US State

Trials by US State for
Location Trials
Arizona 5
Florida 2
Nebraska 2
Pennsylvania 1
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Clinical Trial Progress for ALXN2050

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 3
Phase 1 13
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 8
Recruiting 3
Completed 3
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Clinical Trial Sponsors for ALXN2050

Sponsor Name

Sponsor Name for
Sponsor Trials
Alexion Pharmaceuticals 15
Celerion 4
Achillion, a wholly owned subsidiary of Alexion 3
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 25
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