Phase 3 Study on ABP 959 and PNH

Study Notes

Conducted as a randomized, double-blind, active-controlled phase 3 study on the drug ABP 959.
Target condition: Paroxysmal Nocturnal Hemoglobinuria (PNH).
Comparison between ABP 959 and Eculizumab in adult subjects.

Official title includes evaluation of efficacy and safety.
Study Identifier: 20150168.
Enrollment involved 42 participants.
Started on January 22, 2019; primary and completion dates were both July 12, 2022.
Interventional study focusing on drug treatments.

24 study locations across multiple countries including the United States, Czechia, Finland, France, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey, and the United Kingdom.
Notable sites:
- Atlanta, Georgia, USA: Children's Healthcare of Atlanta at Egleston.
- Brno, Czechia: Fakultní Nemocnice Brno.
- Dublin, Ireland: Saint James's Hospital.
- London, England: King's College Hospital NHS Foundation Trust.

Inclusion Criteria:
- Adults aged 18 and above.
- Historical diagnosis of PNH.
- Must have been on 900 mg of Eculizumab for ≥ 6 months.
- Hemoglobin levels must be ≥ 9.0 g/dL for at least 6 weeks prior to randomization.
- Lactate dehydrogenase levels < 1.5 times the upper limit of normal at screening.
- Platelet count must be ≥ 50 x 10^9/L and absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L.
- Vaccination against Neisseria meningitidis required.
- Participants must provide signed informed consent.
Exclusion Criteria:
- Known or suspected hereditary complement deficiencies.
- Significant cardiovascular diseases or conditions in the last 6 months.
- Evidence of acute thrombosis.
- Known HIV positivity.
- Pregnant or breastfeeding women.
- Recent involvement in other investigational studies within the last 30 days.

NIH National Library of Medicine provided resource links related to PNH and relevant drug information.
The study aims to enhance understanding and treatment options for patients with PNH.