Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
ConditionParoxysmal Nocturnal Hemoglobinuria
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovelMed Therapeutics
About this trial
This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.
Eligibility criteria
Qualifiers
Patients ≥ 18 years (males and females), weight ≥ 45 kg at the time of consent.
Confirmation of PNH diagnosis by flow cytometry evaluation white blood cells (WBCs), with neutrophil, granulocyte and/or monocyte clone size of ≥10%.
Evidence of ongoing hemolysis.
≥1 pRBC transfusion within 12 months prior to screening.
Disqualifiers
Subjects currently or previously under other complement inhibitor treatments other than Soliris less than 3 months prior to study Day 1
History of bone marrow, hematopoietic stem cell, or solid organ transplantation
History of splenectomy
Participation in any other investigational drug trial within 5 elimination half-lives of enrollment, or within 30 days, whichever is longer
Trial design
Treatments tested in this trial
- NM8074
- Soliris
Treatment groups
12 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov