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Clinical Trials/NCT06298955
NCT06298955Active, not recruitingPhase 2

An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Omeros Corporation6 sites in 4 countries25 target enrollmentStarted: February 19, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
25
Locations
6
Primary Endpoint
To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 OMS
  • •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.

Arms & Interventions

OMS906 study drug

Experimental

OMS906 study drug repeat-dose 5 mg/kg IV administration at 8-week intervals.

Intervention: OMS906 study drug (Drug)

Outcomes

Primary Outcomes

To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients.

Time Frame: 104 weeks

Treatment-emergent adverse events, including clinically significant clinical laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations recorded as an adverse event.

Secondary Outcomes

  • To assess efficacy measured by hemoglobin (Hgb).(6 month intervals)
  • To assess efficacy by transfusion requirements.(Weeks 48 and 96)
  • To assess efficacy by measurement of lactate dehydrogenase (LDH).(Weeks 48 and 96)
  • To assess efficacy by measurement of reticulocyte count.(Weeks 48 and 96)
  • To assess efficacy by measurement of clinical breakthrough hemolysis.(Weeks 48 and 96)
  • To assess population PK Cmax of OMS906.(Weeks 48 and 96)
  • To assess population PK AUC of OMS906.(Weeks 48 and 96)
  • To assess population PK terminal half life of OMS906.(Weeks 48 and 96)
  • To assess PD of OMS906(Weeks 48 and 96)
  • OMS906 anti-drug antibodies (ADA).(Weeks 24, 48, 72, and 96)
  • Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score.(Weeks 24, 48, 72, and 96)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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