New drug aims to tame scleroderma in major trial

NCT ID NCT05925803

Ongoing Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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, G1V 3M7, 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

More trials for these conditions

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