Long-Term Safety, Tolerability and Efficacy of OMS906 in... | NCT06298955

Studies
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

NCT06298955

Sponsor

Omeros Corporation

Status

Recruiting

Last Update Posted

Mar 7, 2024Actual

Enrollment

25Estimated

Phase

Phase 2

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Interventions

OMS906 study drug

Countries

Germany
Switzerland
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2024Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Feb 17, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2024

Last Update Posted Date

Mar 7, 2024Actual

Description Module

Brief Summary

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

Detailed Description

This is a multicenter, open-label, single arm study. The primary objective is to assess the long-term safety and tolerability of OMS906 in patients with PNH. Secondary objectives of this study include assessment of the long-term efficacy of OMS906 in patients with PNH. Patients will receive OMS906 5 mg/kg administered as intravenous (IV) injections at 8-week intervals.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OMS906 study drug	Experimental	OMS906 study drug repeat-dose 5 mg/kg IV administration at 8-week intervals.	Drug: OMS906 study drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OMS906 study drug	Drug	OMS906 study drug repeat-dose 5mg/kg IV administration at 8-week intervals	OMS906 study drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients.	Treatment-emergent adverse events, including clinically significant clinical laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations recorded as an adverse event.	104 weeks

Secondary Outcomes

Measure	Description	Time Frame
To assess efficacy measured by hemoglobin (Hgb).	Measured by patients achieving Hb ≥ 12.0 g/dL and by proportion of patients maintaining an increase in Hb ≥ 2 g/dL, achieved in the prior study, through the duration of the long-term extension.	6 month intervals
To assess efficacy by transfusion requirements.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have completed the last dosing visit of the prior OMS906 PNH study.
Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.
Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug.
Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug.
Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.
Have provided informed consent

Exclusion Criteria:

Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period.
Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis.
History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.
Pregnant, planning to become pregnant, or nursing female patients.
History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension.
Unable or unwilling to comply with the requirements of the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Omeros Investigational Site	Not yet recruiting	Aachen			Germany
Omeros Investigational Site

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases