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Be Part of Research - Trial Details - Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab
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Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab

Not Recruiting

Open to: ALL

Age: 18.0 - 99.0

Leeds

Medical Conditions

Hemoglobinuria
Hemoglobinuria, Paroxysmal

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of OMS906 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients who have a sub-optimal response to ravulizumab.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 May 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : All patients will receive 3 doses of OMS906 of 3 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906.

Intervention Arm Group : OMS906 Study Drug - 3 mg/kg IV with Ravulizumab IV;

Intervention Type : DRUG
Intervention Description : All patients will receive 3 doses of OMS906 of 5 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906.

Intervention Arm Group : OMS906 Study Drug - 5 mg/kg IV with Ravulizumab IV;

Intervention Type : DRUG
Intervention Description : Participants must be on prescribed stable dose of ravulizumab (IV dose per approved summary of medicinal product characteristics) for at least 2 doses (4 months) prior to baseline. During the Run-in period - ravulizumab only. During the Treatment period all patients will receive 3 doses of ravulizumab at 8-week intervals. Clinical responders at Week 24 will not receive additional ravulizumab. Incomplete responders may receive an additional 3 doses of ravulizumab with OMS906 at 8-week intervals. Non responders will return to treatment with ravulizumab or standard of care.

Intervention Arm Group : OMS906 Study Drug - 3 mg/kg IV with Ravulizumab IV;OMS906 Study Drug - 5 mg/kg IV with Ravulizumab IV;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Omeros Investigational Site
    Leeds


The study is sponsored by Omeros Corporation



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Read full details for Trial ID: NCT05972967
Last updated 06 January 2025

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