NCT05925803Active, not recruitingPhase 3
Determine effectiveness of Anifrolumab In Systemic sclerosis
A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Sept 2026
Brief summary (registry, in English)
To demonstrate the superiority of anifrolumab to placebo with or without standard therapy on measures of signs, symptoms, and impacts associated with SSc.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 1 Jun 2023
- Start date
- 24 Nov 2023
- Lead sponsor
- Astrazeneca AB
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05925803
- EU CT number
- 2023-505976-31-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 112
- 54 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease \[Child Pugh A, B, C hepatic impairment\]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
- Hematopoietic stem cell transplantation or solid organ/limb transplantation
- Major surgery within 8 weeks prior to and/or during study enrollment
Other illness
- Severe cardiopulmonary disease as defined by the protocol
- Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
- History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
- Any severe case of Herpes Zoster infection as defined by the protocol
- Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
- Known active current or history of recurrent infections
- Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
Lab values
- Anticentromere antibody seropositivity on central laboratory
- History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)
Who the study is looking for
- Adult patients from 18 to 70 years of age inclusive
- Systemic sclerosis according to 2013 ACR/EULAR classification criteria
- Limited or diffuse cutaneous subsets
- Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
- Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
- mRSS \> 10 with early disease or rapid progression as defined by the protocol
- mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
- Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
- Women of childbearing potential with a negative urine pregnancy test
- Uninvolved skin at injection sites
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Johannes Wesling Klinikum Minden Coordinator of this site? Confirm its status | Minden | Germany | Active, not recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Cannock | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz Coordinator of this site? Confirm its status | Budapest II | Hungary | Active, not recruiting |
| Budai Egeszsegkoezpont Zrt. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Gurugram | India | Unknown status |
| - Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| - Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| - Coordinator of this site? Confirm its status | Mysuru | India | Unknown status |
| - Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| - Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospealiero Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Iruma-Gun | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Takatsuki-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Toyoake-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Seremban | Malaysia | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Malopolskie Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Linden Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary w Sosnowcu Coordinator of this site? Confirm its status | Sosnowiec | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Saint Maria Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Spitalul Clinic de Recuperare Iasi Coordinator of this site? Confirm its status | Iasi | Romania | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Babylon | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Hà Nội | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Hochiminh | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Parktown | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Center | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Kazımkarabekir | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
Related publications
- Systemic sclerosis: pathogenic mechanisms and their implications for treatment.Semin Immunopathol · 2025 · PMID 41217519
This page is information, not medical advice. Discuss any trial with your doctor.