Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus ErythematosusPhase 3ROSY-SNCT07691970

Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment

A Phase 3 study testing Anifrolumab in people with Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus, run by AstraZeneca at 153 sites in 35 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability. Read more about this study

Who is it for?: Ages 5 to 80 years
Conditions the study is for: Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
What is being tested?: Anifrolumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,072 participants
Where: 153 sitesin 35 countries
Study dates: 31 Aug 2026to 30 Dec 2032
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

153 sites in 35 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

+1877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

153 sites in 35 countries

United States18 sites, 18 recruiting

Research Site
Ann Arbor, Michigan, 48109
Not yet recruiting
Research Site
Boca Raton, Florida, 33486
Recruiting
Research Site
Charleston, South Carolina, 29425
Not yet recruiting
Research Site
Charlotte, North Carolina, 28207
Recruiting
Research Site
Chicago, Illinois, 60611
Not yet recruiting
Research Site
Cleveland, Ohio, 44195
Not yet recruiting
Research Site
Columbus, Ohio, 43230
Not yet recruiting
Research Site
Dallas, Texas, 75390-8843
Not yet recruiting
Research Site
Fort Lauderdale, Florida, 33309
Recruiting
Research Site
Indianapolis, Indiana, 46202
Not yet recruiting
Research Site
Los Angeles, California, 90045
Recruiting
Research Site
New York, New York, 10029
Not yet recruiting
Research Site
Omaha, Nebraska, 68114
Not yet recruiting
Research Site
Phoenix, Arizona, 85028
Not yet recruiting
Research Site
Portland, Oregon, 97239
Not yet recruiting
Research Site
Roanoke, Virginia, 24016
Not yet recruiting
Research Site
Rochester, Minnesota, 55905
Not yet recruiting
Research Site
San Francisco, California, 94115
Not yet recruiting

Other trials in United States

Germany13 sites, 13 recruiting

Research Site
Berlin, 13353
Not yet recruiting
Research Site
Dresden, 1309
Not yet recruiting
Research Site
Essen, 45122
Not yet recruiting
Research Site
Freiburg im Breisgau, 79104
Not yet recruiting
Research Site
Freiburg im Breisgau, 79106
Not yet recruiting
Research Site
Hanover, 30625
Not yet recruiting
Research Site
Kiel, 24105
Not yet recruiting
Research Site
Mainz, 55131
Not yet recruiting
Research Site
Marburg, 35043
Not yet recruiting
Research Site
Münster, 48149
Not yet recruiting
Research Site
Regensburg, 93053
Not yet recruiting
Research Site
Tübingen, 72076
Not yet recruiting
Research Site
Wuppertal, 42283
Not yet recruiting

Other trials in Germany

Spain12 sites, 12 recruiting

Research Site
A Coruña, 15006
Not yet recruiting
Research Site
Barcelona, 08003
Not yet recruiting
Research Site
Barcelona, 8041
Not yet recruiting
Research Site
Castellon, 12004
Not yet recruiting
Research Site
Granada, 18014
Not yet recruiting
Research Site
Las Palmas de Gran Canaria, 35020
Not yet recruiting
Research Site
Madrid, 28034
Not yet recruiting
Research Site
Madrid, 28041
Not yet recruiting
Research Site
Valencia, 46014
Not yet recruiting
Research Site
Valencia, 46017
Not yet recruiting
Research Site
Valladolid, 47012
Not yet recruiting
Research Site
Vigo, 36200
Not yet recruiting

Other trials in Spain

France10 sites, 10 recruiting

Research Site
Bordeaux, 33076
Not yet recruiting
Research Site
Nantes, 44093
Not yet recruiting
Research Site
Paris, 75010
Not yet recruiting
Research Site
Paris, 75014
Not yet recruiting
Research Site
Paris, 75020
Not yet recruiting
Research Site
Poitiers, 86000
Not yet recruiting
Research Site
Rennes, 35033
Not yet recruiting
Research Site
Strasbourg, 67200
Not yet recruiting
Research Site
Toulouse, 31059
Not yet recruiting
Research Site
Toulouse, 31300
Not yet recruiting

Other trials in France

Italy9 sites, 9 recruiting

Research Site
Brescia, 25123
Not yet recruiting
Research Site
Catania, 95123
Not yet recruiting
Research Site
Cona, 44124
Not yet recruiting
Research Site
Florence, 50121
Not yet recruiting
Research Site
Milan, 20122
Not yet recruiting
Research Site
Milan, 20132
Not yet recruiting
Research Site
Pavia, 27100
Not yet recruiting
Research Site
Roma, 00144
Not yet recruiting
Research Site
Roma, 00168
Not yet recruiting

Other trials in Italy

China8 sites, 8 recruiting

Research Site
Beijing, 100191
Not yet recruiting
Research Site
Chongqing, 400010
Not yet recruiting
Research Site
Guangzhou, 510080
Not yet recruiting
Research Site
Jinan, 250022
Not yet recruiting
Research Site
Lanzhou, 730000
Not yet recruiting
Research Site
Shanghai, 200001
Not yet recruiting
Research Site
Shenzhen, 518020
Not yet recruiting
Research Site
Shenzhen, 518053
Not yet recruiting

Other trials in China

Poland8 sites, 8 recruiting

Research Site
Bydgoszcz, 85-168
Not yet recruiting
Research Site
Katowice, 40-600
Not yet recruiting
Research Site
Kielce, 25-316
Not yet recruiting
Research Site
Krakow, 30-040
Not yet recruiting
Research Site
Krakow, 30-105
Not yet recruiting
Research Site
Lodz, 90-549
Not yet recruiting
Research Site
Ossy, 40-027
Not yet recruiting
Research Site
Warsaw, 00-807
Not yet recruiting

Other trials in Poland

Japan6 sites, 6 recruiting

Research Site
Fukuoka, 812-8582
Not yet recruiting
Research Site
Kanazawa, 920-8641
Not yet recruiting
Research Site
Maebashi, 371-8511
Not yet recruiting
Research Site
Nagoya, 467-8602
Not yet recruiting
Research Site
Sapporo, 060-8648
Not yet recruiting
Research Site
Yokohama, 236-0004
Not yet recruiting

Other trials in Japan

United Kingdom6 sites, 6 recruiting

Research Site
Cambridge, CB2 2QQ
Not yet recruiting
Research Site
Leeds, LS7 4SA
Not yet recruiting
Research Site
London, NW1 2BU
Not yet recruiting
Research Site
London, SE5 9RS
Not yet recruiting
Research Site
Newcastle upon Tyne, NE7 7DN
Not yet recruiting
Research Site
Sheffield, S10 2JF
Not yet recruiting

Other trials in United Kingdom

Thailand5 sites, 5 recruiting

Research Site
Bangkok, 10330
Not yet recruiting
Research Site
Bangkok, 10700
Not yet recruiting
Research Site
Hat Yai, 90110
Not yet recruiting
Research Site
Khon Kaen, 40002
Not yet recruiting
Research Site
Klong Luang, 12120
Not yet recruiting

Other trials in Thailand

Austria4 sites, 4 recruiting

Research Site
Graz, 8010
Not yet recruiting
Research Site
Graz, 8036
Not yet recruiting
Research Site
Linz, 4020
Not yet recruiting
Research Site
Vienna, 1130
Not yet recruiting

Other trials in Austria

Brazil4 sites, 4 recruiting

Research Site
Belo Horizonte, 30150-221
Not yet recruiting
Research Site
Rio de Janeiro, 22470-220
Not yet recruiting
Research Site
Salvador, 40150-150
Not yet recruiting
Research Site
São Paulo, 05403-000
Not yet recruiting

Other trials in Brazil

India4 sites, 4 recruiting

Research Site
Hyderabad, 500082
Not yet recruiting
Research Site
Kolkata, 700020
Not yet recruiting
Research Site
New Delhi, 110060
Not yet recruiting
Research Site
Pune, 411001
Not yet recruiting

Other trials in India

Mexico4 sites, 4 recruiting

Research Site
Guadalajara, 44650
Not yet recruiting
Research Site
Guadalajara, 44950
Not yet recruiting
Research Site
San Luis Potosí City, 78250
Not yet recruiting
Research Site
Veracruz, 91900
Not yet recruiting

Other trials in Mexico

South Korea4 sites, 4 recruiting

Research Site
Seoul, 03080
Not yet recruiting
Research Site
Seoul, 04401
Not yet recruiting
Research Site
Seoul, 06973
Not yet recruiting
Research Site
Seoul, 6591
Not yet recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

Research Site
Kaohsiung City, 813414
Not yet recruiting
Research Site
Kaohsiung City, 83301
Not yet recruiting
Research Site
Taichung, 404327
Not yet recruiting
Research Site
Taipei, 10449
Not yet recruiting

Other trials in Taiwan

Bulgaria3 sites, 3 recruiting

Research Site
Plovdiv, 4001
Not yet recruiting
Research Site
Sofia, 1463
Not yet recruiting
Research Site
Sofia, 1618
Not yet recruiting

Other trials in Bulgaria

Philippines3 sites, 3 recruiting

Research Site
Iloilo City, 5000
Not yet recruiting
Research Site
Lipa City, 4217
Not yet recruiting
Research Site
Manila, 1000
Not yet recruiting

Other trials in Philippines

Portugal3 sites, 3 recruiting

Research Site
Braga, 4710-367
Not yet recruiting
Research Site
Lisbon, 1000-064
Not yet recruiting
Research Site
Porto, 4099-001
Not yet recruiting

Other trials in Portugal

Romania3 sites, 3 recruiting

Research Site
Bucharest, 011172
Not yet recruiting
Research Site
Cluj-Napoca, 400006
Not yet recruiting
Research Site
Iași, 700661
Not yet recruiting

Other trials in Romania

Argentina2 sites, 2 recruiting

Research Site
Quilmes, 1878
Not yet recruiting
Research Site
San Miguel, 1663
Not yet recruiting

Other trials in Argentina

Australia2 sites, 2 recruiting

Research Site
Melbourne, 3004
Not yet recruiting
Research Site
Mitcham, 3132
Not yet recruiting

Other trials in Australia

Belgium2 sites, 2 recruiting

Research Site
Ghent, 9000
Not yet recruiting
Research Site
Leuven, 3000
Not yet recruiting

Other trials in Belgium

Israel2 sites, 2 recruiting

Research Site
Haifa, 31048
Not yet recruiting
Research Site
Kfar Saba, 4428164
Not yet recruiting

Other trials in Israel

Serbia2 sites, 2 recruiting

Research Site
Belgrade, 1100
Not yet recruiting
Research Site
Kragujevac, 34000
Not yet recruiting

Other trials in Serbia

Slovakia2 sites, 2 recruiting

Research Site
Košice, 4001
Not yet recruiting
Research Site
Piešťany, 92101
Not yet recruiting

Other trials in Slovakia

Turkey (Türkiye)2 sites, 2 recruiting

Research Site
Fatih-Istanbul, 34098
Not yet recruiting
Research Site
Ümraniye, 34760
Not yet recruiting

Other trials in Turkey (Türkiye)

Canada1 site, 1 recruiting

Research Site
Québec, G1V 3M7
Not yet recruiting

Other trials in Canada

Chile1 site, 1 recruiting

Research Site
Santiago, 7500571
Not yet recruiting

Other trials in Chile

Colombia1 site, 1 recruiting

Research Site
Bogotá, 110221
Not yet recruiting

Other trials in Colombia

Czechia1 site, 1 recruiting

Research Site
Prague, 12850
Not yet recruiting

Other trials in Czechia

Greece1 site, 1 recruiting

Research Site
Chaïdári, 124 62
Not yet recruiting

Other trials in Greece

Netherlands1 site, 1 recruiting

Research Site
Rotterdam, 3015 GD
Not yet recruiting

Other trials in Netherlands

South Africa1 site, 1 recruiting

Research Site
Johannesburg, 2193
Not yet recruiting

Other trials in South Africa

Vietnam1 site, 1 recruiting

Research Site
Hà Nội, 100000
Not yet recruiting

Other trials in Vietnam

About this study

Official title: ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment

Study details include:

Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
The participants will continue to receive anifrolumab the same way they received it in the parent trial
A participant is considered to have completed the study when they meet one of the discontinuation criteria.
Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

Conditions: Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Being tested: Anifrolumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnifrolumabCombination product
Anifrolumab pre-filled syringe
AnifrolumabCombination product
Anifrolumab solution for injection in pre-filled pen
AnifrolumabDrug
Anifrolumab concentrate for solution for infusion

Study groups in NCT07691970
Study group	Role	What they receive
Anifrolumab	Experimental	This is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria. Receives: Combination Product: Anifrolumab; Drug: Anifrolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

SAEs and Non-Serious AEs
Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab
Measured: From first dose administered and until 12 weeks after the last dose of Anifrolumab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202630 Dec 2032

First posted9 Jul 2026
Study start31 Aug 2026
Primary completion30 Dec 2032 (estimated)
Study completion30 Dec 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: The rationale of the ROSY-S study is to provide continuous access to study treatment for participants clinically benefiting from anifrolumab treatment upon completion of parent studies and monitoring long-term safety and tolerability of anifrolumab. Participants will be enrolled into this study based upon the parent study continuing to receive the same treatment dose and regimen throughout until they meet one of the treatment discontinuation criteria.
Masking: None (open label)
Enrolment: 1,072 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07691970
Sponsor's protocol ID: D346BC00004
Acronym: ROSY-S
Status last verified: Oct 2026
First submitted: 23 Jun 2026
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment
ClinicalTrials.gov ID: NCT07691970
Acronym / sponsor ID: ROSY-S / D346BC00004
Conditions: Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,072 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 31 Aug 2026 (actual)
Primary completion: 30 Dec 2032 (estimated)
Study completion: 30 Dec 2032 (estimated)
First posted: 9 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study details include:

Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
The participants will continue to receive anifrolumab the same way they received it in the parent trial
A participant is considered to have completed the study when they meet one of the discontinuation criteria.
Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The rationale of the ROSY-S study is to provide continuous access to study treatment for participants clinically benefiting from anifrolumab treatment upon completion of parent studies and monitoring long-term safety and tolerability of anifrolumab. Participants will be enrolled into this study based upon the parent study continuing to receive the same treatment dose and regimen throughout until they meet one of the treatment discontinuation criteria.

Arm	Type	Receives
Anifrolumab	Experimental	Combination Product: Anifrolumab, Drug: AnifrolumabThis is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria.

Who may qualify

Ages: 5 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AnifrolumabAnifrolumab pre-filled syringe	Combination product	Anifrolumab
AnifrolumabAnifrolumab solution for injection in pre-filled pen	Combination product	Anifrolumab
AnifrolumabAnifrolumab concentrate for solution for infusion	Drug	Anifrolumab

Primary outcome

SAEs and Non-Serious AEs
Time frame: From first dose administered and until 12 weeks after the last dose of Anifrolumab
Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

+1877-240-9479

information.center@astrazeneca.com

153 sites in 35 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anifrolumab in people with Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus, run by AstraZeneca at 153 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Germany, Spain, France, Italy and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (+1877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAEs and Non-Serious AEs (time frame: From first dose administered and until 12 weeks after the last dose of Anifrolumab). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07691970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.