Cure My Disease

Don't miss your cure!

 Log in / Sign up

Continued anifrolumab treatment studied for lupus and related diseases

NCT ID NCT07691970

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study offers continued access to anifrolumab (Saphnelo) for people with systemic lupus erythematosus, systemic sclerosis, or myopathies who completed a prior anifrolumab trial and are still benefiting from the drug. Participants receive the same treatment as before, while researchers monitor long-term safety and side effects. The goal is to gather more information on the drug's safety over extended use.

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 show that long-term anifrolumab use is safe and effective for managing autoimmune diseases like lupus.
What could go wrong
This is an open-label rollover study, not a placebo-controlled trial, so results may be less definitive. Side effects remain possible with continued treatment.

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 1,072 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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

5 to 80 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: * Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study. * In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment. * Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Capable of adhering to the treatment plan related to this ROSY-S study. Exclusion Criteria: * Participant develops hypersensitivity to any of the components of anifrolumab. * Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study. * Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer. * Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab. * Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF. * Participants who are planning to use live/live-attenuated vaccines. * Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator. * Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments. * Participants who discontinued the parent study prior to completion of all study visits. * Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cutaneous lupus erythematosus are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus myopathy systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis cutaneous lupus E myopathies systemic lupus erythematosus

How to take part

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

  1. The places running it

    41 sites in 22 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

    Los Angeles, California, 90045, United States

  • Research Site

    Fort Lauderdale, Florida, 33309, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    Charleston, South Carolina, 29425, United States

  • Research Site

    Graz, 8010, Austria

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Salvador, 40150-150, Brazil

  • Research Site

    Sofia, 1618, Bulgaria

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Strasbourg, 67200, France

  • Research Site

    Toulouse, 31300, France

  • Research Site

    Chaïdári, 124 62, Greece

  • Research Site

    Kolkata, 700020, India

  • Research Site

    Haifa, 31048, Israel

  • Research Site

    Milan, 20122, Italy

  • Research Site

    Sapporo, 060-8648, Japan

  • Research Site

    Iloilo City, 5000, Philippines

  • Research Site

    Lipa City, 4217, Philippines

  • Research Site

    Bydgoszcz, 85-168, Poland

  • Research Site

    Kielce, 25-316, Poland

  • Research Site

    Krakow, 30-040, Poland

  • Research Site

    Iași, 700661, Romania

  • Research Site

    Kragujevac, 34000, Serbia

  • Research Site

    Piešťany, 92101, Slovakia

  • Research Site

    Seoul, 6591, South Korea

  • Research Site

    Barcelona, 8041, Spain

  • Research Site

    Granada, 18014, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Valencia, 46014, Spain

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 404327, Taiwan

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Fatih-Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Research Site

    Sheffield, S10 2JF, United Kingdom

More trials for these conditions

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