Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 30, 2026

Primary Completion Date

September 30, 2027

Study Completion Date

March 31, 2028

Conditions
PNH - Paroxysmal Nocturnal Hemoglobinuria
Interventions
DRUG

NM8074

"NM8074 will be administered as an intravenous infusion. All enrolled subjects will receive a dose of 15 mg/kg NM8074 once every two weeks for a total of 6 doses from Day1 to Day 84.~For Soliris-treated PNH subjects, admission and dosing of NM8074 on Day 1 should be scheduled to coincide with the next scheduled dose of Soliris (i.e., 14 ± 2 days after the last Soliris dose). Soliris should NOT be administered on Day 1 or at any time thereafter during course of the study.~Subjects in the treatment groups will receive a dose of 15 mg/kg of NM8074 on Day 1, which will be administered during the study visit by the site staff. During the remainder of the treatment period, subjects will be given another 15 mg/kg dose every two weeks at approximately the same time. On days of scheduled study visits at the Investigation Site, the dose must be administered after blood work is completed."

Sponsors
All Listed Sponsors
lead

NovelMed Therapeutics

INDUSTRY