NCT06298955

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
11mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Feb 2024Apr 2027

First Submitted

Initial submission to the registry

February 17, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

February 17, 2024

Last Update Submit

March 1, 2024

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Keywords

PNH

Outcome Measures

Primary Outcomes (1)

  • 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 (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

OMS906 study drug

EXPERIMENTAL

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

Drug: OMS906 study drug

Interventions

OMS906 study drugDRUG

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

OMS906 study drug

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Omeros Investigational Site

Aachen, Germany

NOT YET RECRUITING

Omeros Investigational Site

Ulm, Germany

NOT YET RECRUITING

Omeros Investigational Site

Lausanne, Switzerland

RECRUITING

Omeros Investigational Site

Kyiv, Ukraine

NOT YET RECRUITING

Omeros Investigational Site

Leeds, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Study Officials

  • William Pullman

    Omeros Corporation

    STUDY DIRECTOR

Central Study Contacts

Omeros Clinical Trial Information

CONTACT

206-676-5000ctinfo@omeros.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2024

First Posted

March 7, 2024

Study Start

February 19, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

March 7, 2024

Record last verified: 2024-02

Locations

GB(1)DE(2)UA(1)CH(1)