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New lupus drug saphnelo tracked for Long-Term safety in 1,600+ patients

NCT ID NCT05141201

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking the long-term safety and effectiveness of the drug Saphnelo (anifrolumab) in over 1,600 people with systemic lupus erythematosus who haven't responded well to current treatments. Researchers are monitoring for side effects like serious infections, shingles, and allergic reactions. The goal is to see how well the drug works in real-world use 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
Anifrolumab (Saphnelo)
What this could lead to
If successful, this study could confirm that anifrolumab is a safe and effective long-term option for controlling lupus in people who haven't responded to other treatments.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Risks include serious infections, shingles, and allergic reactions, as noted in the study.

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

1,620 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Mar 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.

Who is studied

patients with systemic lupus erythematosus insufficiently responding to currently available treatment

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: patients with systemic lupus erythematosus insufficiently responding to currently available treatment - Exclusion Criteria: None \-

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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

Contacts and locations

Locations

  • Research Site

    Aichi, Japan

  • Research Site

    Akita, Japan

  • Research Site

    Aomori, Japan

  • Research Site

    Chiba, Japan

  • Research Site

    Ehime, Japan

  • Research Site

    Fukui, Japan

  • Research Site

    Fukuoka, Japan

  • Research Site

    Fukushima, Japan

  • Research Site

    Gifu, Japan

  • Research Site

    Gunma, Japan

  • Research Site

    Hiroshima, Japan

  • Research Site

    Hokkaido, Japan

  • Research Site

    Hyōgo, Japan

  • Research Site

    Ibaraki, Japan

  • Research Site

    Ishikawa, Japan

  • Research Site

    Kagawa, Japan

  • Research Site

    Kagoshima, Japan

  • Research Site

    Kanagawa, Japan

  • Research Site

    Kochi, Japan

  • Research Site

    Kumamoto, Japan

  • Research Site

    Kyoto, Japan

  • Research Site

    Mie, Japan

  • Research Site

    Miyagi, Japan

  • Research Site

    Miyazaki, Japan

  • Research Site

    Nagano, Japan

  • Research Site

    Nagasaki, Japan

  • Research Site

    Nara, Japan

  • Research Site

    Niigata, Japan

  • Research Site

    Numakunai, Japan

  • Research Site

    Okayama, Japan

  • Research Site

    Okinawa, Japan

  • Research Site

    Osaka, Japan

  • Research Site

    Ōita, Japan

  • Research Site

    Saga, Japan

  • Research Site

    Saitama, Japan

  • Research Site

    Shiga, Japan

  • Research Site

    Shimane, Japan

  • Research Site

    Shizuoka, Japan

  • Research Site

    Tochigi, Japan

  • Research Site

    Tokushima, Japan

  • Research Site

    Tokyo, Japan

  • Research Site

    Tottori, Japan

  • Research Site

    Toyama, Japan

  • Research Site

    Wakayama, Japan

  • Research Site

    Yamagata, Japan

  • Research Site

    Yamaguchi, Japan

  • Research Site

    Yamanashi, Japan

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