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New lupus drug tracked in global real-world study

NCT ID NCT06314282

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 5 times

Summary

This study follows 200 adults with lupus who are starting anifrolumab for the first time, to see how well it works in everyday clinics. Researchers will measure disease activity, skin symptoms, fatigue, and quality of life over time. The goal is to provide real-world evidence to help doctors, insurers, and patients make informed treatment decisions.

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 200 people

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

Started

Oct 2024

Expected to finish

Dec 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

10 to 50 patients will be enrolled per country from academic, community and hospital outpatient settings, to maximize the representation of the study population. This will result in approximately 180-200 patients in total allowing for sufficient precision when analysing the total cohort and to explore subgroups of interest.

Ages

18 years and older

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. Aged 18 years or older at study enrolment. 2. Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry. 3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label. 4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion. 5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry. 6. Provided informed consent to participate in the study. 7. Willing and able to participate in all required study evaluations and procedures. Exclusion Criteria: 1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product. 2. Previous exposure to anifrolumab as part of a clinical trial or early access program. 3. 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. 4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

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Conditions

The condition(s) this trial relates to.

autoimmune disease systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus (SLE)

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 in 3 countries. 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

    Cairo, Egypt

  • Research Site

    ACTIVE_NOT_RECRUITING

    Guatemala City, Guatemala

  • Research Site

    ACTIVE_NOT_RECRUITING

    Aktobe, Kazakhstan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Almaty, Kazakhstan

  • Research Site

    WITHDRAWN

    Almaty, Kazakhstan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Astana, Kazakhstan

  • Research Site

    WITHDRAWN

    Astana, Kazakhstan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Pavlodar, Kazakhstan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Semey, Kazakhstan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Shymkent, Kazakhstan

  • Research Site

    RECRUITING

    Kuwait City, Kuwait

  • Research Site

    RECRUITING

    Mexico City, Mexico

  • Research Site

    RECRUITING

    Mérida, Mexico

  • Research Site

    ACTIVE_NOT_RECRUITING

    Muscat, Oman

  • Research Site

    ACTIVE_NOT_RECRUITING

    Doha, Qatar

  • Research Site

    ACTIVE_NOT_RECRUITING

    ASIR, Saudi Arabia

  • Research Site

    ACTIVE_NOT_RECRUITING

    Jeddah, Saudi Arabia

  • Research Site

    ACTIVE_NOT_RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    ACTIVE_NOT_RECRUITING

    Kaohsiung City, Taiwan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Taichung, Taiwan

  • Research Site

    WITHDRAWN

    Taichung, Taiwan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Taipei, Taiwan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Taoyuan, Taiwan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Buenos Aires, Argentina

  • Research Site

    ACTIVE_NOT_RECRUITING

    Córdoba, Argentina

  • Research Site

    WITHDRAWN

    Guangzhou, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hong Kong, China

  • Research Site

    WITHDRAWN

    Shenzhen, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Zhongshan, China

  • Research Site

    WITHDRAWN

    Zhuhai, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    San José, Costa Rica

  • Research Site

    RECRUITING

    Alexandria, Egypt

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