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A Phase Ib, Open Label, Multiple Ascending Dose, Pilot Study to Assess the Safety, Preliminary Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Profile

A Phase Ib, Open Label, Multiple Ascending Dose, Pilot Study to Assess the Safety, Preliminary Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Oct 2022

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At a glance

  • Drugs Pegcetacoplan (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms PADDOCK
  • Sponsors Apellis Pharmaceuticals

    • Most Recent Events

    • 01 Oct 2022 Results of post-hoc analysis (n=22) assessing normalization rates of hematologic markers, fatigue, and safety after 16 weeks of pegcetacoplan monotherapy in a subgroup of patients with PNH and baseline hemoglobin levels ≥10.0 g/dL from the PEGASUS (NCT03500549), PADDOCK (NCT02588833), and PRINCE (NCT04085601) studies, published in the Clinical Lymphoma, Myeloma & Leukemia.
    • 19 Aug 2022 Results of pooled analysis assessing safety and efficacy of pegcetacoplan in complement inhibitor-naive adults (≥ 18 years) diagnosed with PNH published in the Annals of Hematology
    • 17 Jun 2022 Results of post hoc analysis (n=22) assessing hemoglobin, lactate dehydrogenase, absolute reticulocyte count, and functional assessment of chronic illness therapy-fatigue normalization rates and safety after PEG treatment in a subgroup of patients with PNH and baseline Hb levels greater than equal to 10.0g/dL from the PADDOCK, PEGASUS, and PRINCE studies, presented at the 27th Congress of the European Haematology Association.
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