Myelodysplastic Syndrome Clinical Trial

Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab

Summary

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of PNH by flow cytometry
Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab

Exclusion Criteria:

History of meningococcal disease
Current systemic infection or suspicion of active bacterial infection

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

3

Study ID:

NCT03030183

Recruitment Status:

Completed

Sponsor:

Ra Pharmaceuticals

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There are 6 Locations for this study

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Investigative Site
Duarte California, 91010, United States
Investigative Site
Los Angeles California, 90033, United States
Investigative Site
Chicago Illinois, 60612, United States
Investigative Site
Manhasset New York, 11030, United States
Investigative Site
Durham North Carolina, 27710, United States
Investigative Site
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

3

Study ID:

NCT03030183

Recruitment Status:

Completed

Sponsor:


Ra Pharmaceuticals

How clear is this clinincal trial information?

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