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New lupus drug anifrolumab put to the test in everyday clinics

NCT ID NCT07424261

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study is tracking 125 adults with lupus who are starting a new drug called anifrolumab, given as a shot under the skin. Researchers want to see how many patients achieve remission (no active disease) after 24 months of treatment in real-world clinics, not just in strict research settings. The goal is to understand if this drug works well outside of clinical trials.

What this could mean

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

Active substance
anifrolumab (a drug given as a shot under the skin)
What this could lead to
If successful, this could show that anifrolumab helps more lupus patients reach remission in real-world settings, supporting its use as a standard treatment.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It's also relatively small (125 people) and only follows patients for 24 months.

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.

Participants

About 125 people

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

Started

Mar 2026

Expected to finish

Aug 2029

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.

Who is studied

125 patients ≥18 years of age, who have been diagnosed with systemic lupus erythematosus (SLE) and who are initiated on subcutaneous (SC) anifrolumab therapy independently of the study and in line with the applicable european summary of product characteristics (SmPC) within routine clinical practice neither having used subcutaneous nor intravenous (IV) anifrolumab before will be enrolled. Patients must be willing and able to report PROs. Eligible patients will be enrolled into the study after the after the treating physicians' diagnostic and therapeutic decisions.

Ages

18 to 130 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: * Age ≥18 years at the time of signing the informed consent * Diagnosis of SLE * Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC) * Prescription of anifrolumab SC was decided prior to and independently of the study * Signed and dated written informed consent prior to enrolment into the study * Willing and able to participate in all study evaluations and procedures Exclusion Criteria: * Prior exposure to anifrolumab * Treatment with concurrent biologics * Current or planned participation in a clinical study that does not constitute routine care * Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus * Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits) * Pregnancy or breast feeding at study enrolment

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Conditions

The condition(s) this trial relates to.

Fatigue systemic lupus erythematosus

As listed by the trial registrant

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

Lupus erythematosus, systemic

How to take part

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

  1. The places running it

    19 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

    RECRUITING

    Altenburg, Germany

  • Research Site

    RECRUITING

    Bad Bramstedt, Germany

  • Research Site

    RECRUITING

    Berlin, Germany

  • Research Site

    RECRUITING

    Braunschweig, Germany

  • Research Site

    RECRUITING

    Chemnitz, Germany

  • Research Site

    RECRUITING

    Erlangen, Germany

  • Research Site

    RECRUITING

    Heidelberg, Germany

  • Research Site

    RECRUITING

    Herne, Germany

  • Research Site

    RECRUITING

    Kassel, Germany

  • Research Site

    RECRUITING

    Leipzig, Germany

  • Research Site

    RECRUITING

    Meerbusch-Lank, Germany

  • Research Site

    RECRUITING

    München, Germany

  • Research Site

    RECRUITING

    Neunkirchen, Germany

  • Research Site

    RECRUITING

    Planegg, Germany

  • Research Site

    RECRUITING

    Schwerin, Germany

  • Research Site

    RECRUITING

    Trier, Germany

  • Research Site

    RECRUITING

    Wetzlar, Germany

  • Research Site

    RECRUITING

    Wuppertal, Germany

  • Research Site

    RECRUITING

    Würzburg, Germany

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