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. |
| NCT04623710 ↗ | Study of ALXN2050 in Participants With Renal Impairment | Not yet recruiting | Alexion Pharmaceuticals | Phase 1 | This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for ALXN2050
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Clinical Trial Sponsors for ALXN2050
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