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Every-8-Week shot could simplify PNH treatment

NCT ID NCT06298955

Disease control Sponsor: Omeros Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests the long-term safety of an experimental drug called OMS906 in people with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Participants receive OMS906 as an intravenous infusion every 8 weeks. The goal is to see if this dosing schedule is safe and tolerable over time, and to check if it helps maintain healthy hemoglobin levels and reduce the need for blood transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OMS906, an experimental drug given intravenously every 8 weeks
What this could lead to
If successful, this could provide a convenient, long-term treatment option for people with PNH, reducing the need for frequent infusions.
What could go wrong
This is an early-phase, open-label study with only 25 participants, so results may not apply to all patients. Long-term safety and effectiveness are still unproven.
Why investors are watching

Omeros is testing its drug OMS906 in patients with paroxysmal nocturnal hemoglobinuria, a rare blood disease. This small phase 2 trial checks whether repeat doses are safe and tolerable over the long term. For a small company, this readout matters because OMS906 is a key product in its pipeline, and a clear safety signal could support further development.

If it works: If the drug shows a good safety profile and keeps the disease under control, Omeros could move closer to a larger trial or regulatory discussions. That progress could strengthen the company's position with investors and partners.

If it fails: The trial could show safety problems or poor tolerability, which would likely delay or end the program. Many phase 2 trials fail, and for a small company, a setback here could weigh heavily on its prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have completed the last dosing visit of the prior OMS906 PNH study. 2. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906. 3. 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. 4. 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. 5. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study. 6. Have provided informed consent Exclusion Criteria: 1. Platelet count \<30,000/µL or absolute neutrophil count \<500 cells/µL at the start of the Evaluation Period. 2. 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. 3. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation. 4. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis. 5. Pregnant, planning to become pregnant, or nursing female patients. 6. 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. 7. Unable or unwilling to comply with the requirements of the study.

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Conditions

The condition(s) this trial relates to.

Hemoglobinuria, Paroxysmal paroxysmal nocturnal hemoglobinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal nocturnal hemoglobinuria

Contacts and locations

Locations

  • Omeros Investigational Site

    Aachen, Germany

  • Omeros Investigational Site

    Ulm, Germany

  • Omeros Investigational Site

    Lausanne, Switzerland

  • Omeros Investigational Site

    Kyiv, Ukraine

  • Omeros Investigational Site

    Leeds, United Kingdom

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