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)

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)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2018

At a glance

  • Drugs APL 2 (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions
  • Acronyms PADDOCK
  • Sponsors Apellis Pharmaceuticals
  • Most Recent Events

    • 16 Apr 2018 According to the Apellis Pharmaceuticals media release, till date two patients have been treated at 180 mg/day of APL-2 administered by subcutaneous injection and nine patients have been treated with 270 mg/day of APL-2 administered by subcutaneous injection for at least 28 days
    • 16 Apr 2018 According to the Apellis Pharmaceuticals media release, interim data excludes results from one of the nine patients treated with 270 mg/day of APL-2, who had underlying metastatic ovarian cancer with a chronic low gastrointestinal bleed, unknown at the time of screening, which resulted in artificially low Hgb and high LDH levels that were determined to be unrelated to PNH, and excludes results from the initial cohort of two patients treated with APL-2 at a dose of 180 mg/day.
    • 16 Apr 2018 Interim results presented in the Apellis Pharmaceuticals media release.
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