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New COPD drug tozorakimab moves to Long-Term safety check

NCT ID NCT07566195

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 9 times

Summary

This study is testing the long-term safety of a drug called tozorakimab in people with chronic obstructive pulmonary disease (COPD) who have had flare-ups in the past. About 82 participants who completed earlier studies will receive tozorakimab and be monitored for side effects. The goal is to see if the drug remains safe over time.

What this could mean

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

Active substance
tozorakimab (a drug given as an injection)
What this could lead to
If successful, this could show that tozorakimab is safe for long-term use and help control COPD flare-ups.
What could go wrong
This is an open-label study with no placebo group, so results may be less reliable. It only includes people who already tolerated the drug in earlier trials, which may not reflect the broader COPD population.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 59 people

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

Started

May 2026

Expected to finish

Dec 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Participants previously randomized in predecessor studies. 2. Participants should be affiliated with the French Social Security system. 3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies. 4. Capable of giving signed informed consent. Exclusion Criteria: 1. Clinically important pulmonary disease other than COPD. 2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor. 3. Current alcohol, drug or chemical abuse. 4. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO. 5. Known history of: 1. Severe allergic reaction to any monoclonal and polyclonal antibody. 2. Allergy or reaction to any component of the IMP formulation. 6. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO. 7. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO. 8. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication. 9. Chronic use of antibiotics if the duration of treatment is \< 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose/regimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy. 10. Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1. 11. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration). 12. Participation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer. 13. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site). 14. Participants who are not able to comply with the study requirements, procedures, and restrictions.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

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

Chronic obstructive pulmonary disease COPD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    ACTIVE_NOT_RECRUITING

    Aix-en-Provence, 13616, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Brest, 29609, France

  • Research Site

    WITHDRAWN

    Colmar, 68024, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Gleizé, 69400, France

  • Research Site

    RECRUITING

    Grenoble, 38043, France

  • Research Site

    RECRUITING

    Lyon, 69317, France

  • Research Site

    RECRUITING

    Marseille, 13015, France

  • Research Site

    RECRUITING

    Montpellier, 34295, France

  • Research Site

    RECRUITING

    Pessac, 33600, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Pringy, 74374, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Quimper, 29000, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Saint-Herblain, 44800, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Toulouse, 31000, France

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