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New drug aims to tame scleroderma in major trial

NCT ID NCT05925803

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This Phase 3 study tests whether anifrolumab, given as a weekly shot, can improve symptoms of systemic sclerosis (scleroderma) compared to a placebo. About 314 adults aged 18-70 with early-stage disease will take part. The main goal is to see if more people respond to treatment, measured by changes in skin, lung function, and daily activities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anifrolumab
What this could lead to
If successful, this could provide a new treatment option to control symptoms and slow disease progression in people with systemic sclerosis.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects are possible. It is not a cure.

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

314 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Apr 2028

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

18 to 70 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.

Key Inclusion Criteria: 1. Adult patients from 18 to 70 years of age inclusive 2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria 3. Limited or diffuse cutaneous subsets 4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF 5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points 6. mRSS \> 10 with early disease or rapid progression as defined by the protocol 7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol 8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus 9. Women of childbearing potential with a negative urine pregnancy test 10. Uninvolved skin at injection sites Key Exclusion Criteria: 1. Anticentromere antibody seropositivity on central laboratory 2. Severe cardiopulmonary disease as defined by the protocol 3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2) 4. 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) 5. 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 6. 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 7. Hematopoietic stem cell transplantation or solid organ/limb transplantation 8. Any severe case of Herpes Zoster infection as defined by the protocol 9. 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 10. Major surgery within 8 weeks prior to and/or during study enrollment 11. Known active current or history of recurrent infections 12. 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

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Conditions

The condition(s) this trial relates to.

autoimmune disease diffuse scleroderma immune system disorder interstitial lung disease scleroderma systemic sclerosis

As listed by the trial registrant

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

Scleroderma Systemic sclerosis

Contacts and locations

Locations

  • Research Site

    Scottsdale, Arizona, 85259, United States

  • Research Site

    Chula Vista, California, 91910, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    New Haven, Connecticut, 06519, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Boca Raton, Florida, 33486, United States

  • Research Site

    Fort Lauderdale, Florida, 33309, United States

  • Research Site

    Gainesville, Florida, 32603, United States

  • Research Site

    Jacksonville, Florida, 32216, United States

  • Research Site

    Margate, Florida, 33063, United States

  • Research Site

    South Miami, Florida, 33143, United States

  • Research Site

    Tamarac, Florida, 33321, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Kansas City, Kansas, 66160, United States

  • Research Site

    New Orleans, Louisiana, 70121, United States

  • Research Site

    Baltimore, Maryland, 21224, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Babylon, New York, 11702, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Cincinnati, Ohio, 45219, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Research Site

    Allen, Texas, 75013, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Innsbruck, 6020, Austria

  • Research Site

    Vienna, 1090, Austria

  • Research Site

    Ghent, B-9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Research Site

    Toronto, Ontario, M5T 3L9, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Montreal, Quebec, H4J 1C5, Canada

  • Research Site

    Québec, Quebec, G1V 4K5, Canada

  • Research Site

    Beijing, 100191, China

  • Research Site

    Beijing, CN-100730, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Guangzhou, 510530, China

  • Research Site

    Hangzhou, 310014, China

  • Research Site

    Lanzhou, 730000, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shanghai, 201210, China

  • Research Site

    Tianjin, 300050, China

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Brest, 29609, France

  • Research Site

    Paris, 75020, France

  • Research Site

    Paris, 75679, France

  • Research Site

    Rennes, 35033, France

  • Research Site

    Strasbourg, 67098, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    Minden, 32429, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Tübingen, 72076, Germany

  • Research Site

    Budapest, 1023, Hungary

  • Research Site

    Budapest, 1027, Hungary

  • Research Site

    Budapest, 1138, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Pécs, 7632, Hungary

  • Research Site

    Szeged, 6725, Hungary

  • Research Site

    Ahmedabad, 380006, India

  • Research Site

    Delhi, 110060, India

  • Research Site

    Gurugram, 122001, India

  • Research Site

    Hyderabad, 500082, India

  • Research Site

    Kolkata, 700020, India

  • Research Site

    Mumbai, 400053, India

  • Research Site

    Mysuru, 570004, India

  • Research Site

    New Delhi, 11029, India

  • Research Site

    Pune, 411001, India

  • Research Site

    Secunderabad, 500003, India

  • Research Site

    Afula, 18101, Israel

  • Research Site

    Haifa, 31048, Israel

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Jerusalem, 00000, Israel

  • Research Site

    Kfar Saba, 4428164, Israel

  • Research Site

    Ramat Gan, 52621, Israel

  • Research Site

    Ancona, 60126, Italy

  • Research Site

    Brescia, 25123, Italy

  • Research Site

    Cona, 44124, Italy

  • Research Site

    Milan, 20122, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Roma, 00128, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Roma, 161, Italy

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Iruma-Gun, 350-0495, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Maebashi, 371-8511, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Nagoya, 457-0866, Japan

  • Research Site

    Sapporo, 060-8638, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Shinjuku-ku, 160-8582, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Takatsuki-shi, 569-8686, Japan

  • Research Site

    Toyoake-shi, 470-1192, Japan

  • Research Site

    Yokohama, 236-0004, Japan

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Seremban, 70300, Malaysia

  • Research Site

    Chihuahua City, 31000, Mexico

  • Research Site

    Guadalajara, 44158, Mexico

  • Research Site

    Guadalajara, 44650, Mexico

  • Research Site

    Mexico City, 06700, Mexico

  • Research Site

    San Luis Potosí City, 78213, Mexico

  • Research Site

    San Luis Potosí City, 78250, Mexico

  • Research Site

    Groningen, 9713 GZ, Netherlands

  • Research Site

    Bydgoszcz, 85-168, Poland

  • Research Site

    Krakow, 30-002, Poland

  • Research Site

    Krakow, 30-105, Poland

  • Research Site

    Lodz, 90-549, Poland

  • Research Site

    Sosnowiec, 41-200, Poland

  • Research Site

    Warsaw, 00-874, Poland

  • Research Site

    Bucharest, 011172, Romania

  • Research Site

    Bucharest, 020475, Romania

  • Research Site

    Cluj-Napoca, 400006, Romania

  • Research Site

    Iași, 700661, Romania

  • Research Site

    Parktown, 2193, South Africa

  • Research Site

    Pretoria, 0083, South Africa

  • Research Site

    Busan, 49241, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 04401, South Korea

  • Research Site

    Seoul, 04763, South Korea

  • Research Site

    Seoul, 137-701, South Korea

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Barcelona, 08003, Spain

  • Research Site

    Barcelona, 08041, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29009, Spain

  • Research Site

    Valencia, 46017, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Ankara, 06100, Turkey (Türkiye)

  • Research Site

    Ankara, 06230, Turkey (Türkiye)

  • Research Site

    Antalya, 07059, Turkey (Türkiye)

  • Research Site

    Center, 23200, Turkey (Türkiye)

  • Research Site

    Kazımkarabekir, 01230, Turkey (Türkiye)

  • Research Site

    Kocaeli, 41380, Turkey (Türkiye)

  • Research Site

    Cannock, WS11 2XY, United Kingdom

  • Research Site

    Leeds, LS7 4SA, United Kingdom

  • Research Site

    London, NW3 2QG, United Kingdom

  • Research Site

    Sheffield, S10 2JF, United Kingdom

  • Research Site

    Hanoi, 10000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Ho Chi Minh City, 70000, Vietnam

  • Research Site

    Hochiminh, 70000, Vietnam

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