Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New lupus drug aims to cut steroid use in italian patients

NCT ID NCT07330245

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 4 times

Summary

This study follows 218 adults with systemic lupus erythematosus (SLE) in Italy who are starting anifrolumab (Saphnelo) for the first time. Researchers want to see if the drug helps patients reach a state of low disease activity while taking 5 mg or less of steroids daily. The study lasts 52 weeks and is observational, meaning no extra treatments are given—just real-world tracking.

What this could mean

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

Active substance
anifrolumab (Saphnelo), a biologic drug that blocks type I interferon
What this could lead to
If successful, this study could show that anifrolumab helps lupus patients achieve better disease control with fewer steroids.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also early-stage and focused only on Italian patients, so findings may not apply broadly.

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 218 people

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

Started

Dec 2025

Expected to finish

Sep 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.

Who is studied

Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Provided informed consent to participate in the study; * Aged 18 years or older; * Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry; * Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria; Exclusion Criteria: * Patients who are at LLDAS5 at the time of study entry; * Previous exposure to anifrolumab; * Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy \[mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids\], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus * Currently participating in any interventional clinical trial with an investigational product; * Inability to understand and sign the informed consent and to fill in patient questionnaires

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lupus erythematosus, systemic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

    21 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

  • AOU Ospedali Riuniti di Ancona - Presidio Torrette

    RECRUITING

    Ancona, 60126, Italy

  • AOUI Verona - Ospedale Borgo Roma

    RECRUITING

    Verona, 37134, Italy

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine

    RECRUITING

    Udine, 33100, Italy

  • Azienda Ospedaliera Ordine Mauriziano Umberto I

    NOT_YET_RECRUITING

    Torino, 10128, Italy

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    NOT_YET_RECRUITING

    Naples, Italy

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliera di Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

    NOT_YET_RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero-Universitaria Policlinico di Bari

    WITHDRAWN

    Bari, 70124, Italy

  • Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato

    RECRUITING

    Monserrato, CA, 09032, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna

    RECRUITING

    Cona, Ferrara, 44124, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

    RECRUITING

    Trieste, 34128, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • IRCCS Casa Sollievo della Sofferenza

    RECRUITING

    San Giovanni Rotondo, Foggia, Italy

  • IRCCS Humanitas Research Hospital

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • IRCCS Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, Italy

  • Policlinico Tor Vergata

    NOT_YET_RECRUITING

    Roma, 00133, Italy

  • Policlinico Umberto I - Sapienza Università di Roma

    RECRUITING

    Roma, 00161, Italy

  • Policlinico di Modena - AOU di Modena

    NOT_YET_RECRUITING

    Modena, 41124, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.