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Clinical trial

A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study

ID
Name
RA101495-01.202
Description
The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical study.
Trial arms
Trial start
2017-07-17
Estimated PCD
2021-09-07
Trial end
2021-10-26
Status
Terminated
Phase
Early phase I
Treatment
Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
Arms:
Zilucoplan (RA101495)
Size
19
Primary endpoint
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
From Day 1 until the Final Study Visit (up to Month 49)
Percentage of Participants With Serious TEAEs
From Day 1 until the Final Study Visit (up to Month 49)
Eligibility criteria
Inclusion Criteria: * Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan (RA101495) PNH study * Evidence of ongoing clinical benefit in the opinion of the Investigator Exclusion criteria: * History of meningococcal disease * Current systemic infection or suspicion of active bacterial infection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

1 indication

Organization
Ra Pharmaceuticals
Product
Zilucoplan
Indication
Paroxysmal Nocturnal Hemoglobinuria