Weekly shot aims to tame rare muscle diseases

NCT ID NCT06455449

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests anifrolumab, a weekly injection, for adults with moderate to severe polymyositis or dermatomyositis—rare diseases that cause muscle weakness and inflammation. About 240 participants will receive either anifrolumab or a placebo added to their usual care for 52 weeks, then everyone gets the drug for another year. The goal is to see if it improves muscle strength and allows lower steroid doses.

What this could mean

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

Active substance: Anifrolumab (a biologic drug given as a weekly shot)
What this could lead to: If it works, this could provide a new treatment option to control disease activity and reduce steroid dependence for people with polymyositis or dermatomyositis.
What could go wrong: This is a Phase 3 trial, but anifrolumab is already approved for lupus, not myositis. It may not work for all patients, and side effects like infections are possible.

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 240 people

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

Started

Jun 2024

Expected to finish

Aug 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 75 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.

Capable of giving informed consent. Inclusion Criteria: 1. 18 - 75 years old 2. Body weight ≥40 kg 3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis. 4. Moderate or severe disease activity per core set measurements. 5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose. 6. No history of active tuberculosis or severe COVID-19. 7. Male and female participants must follow contraception guidelines. Exclusion Criteria: 1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies). 2. PM and DM patients at a high risk of malignancy. 3. Participants with rapidly progressive interstitial lung disease. 4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion. 5. Any history of severe case of herpes zoster infection 6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV . 7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF. 8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization. 9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment. 10. Recent or concurrent enrollment in another clinical study with an investigational product. 11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

dermatomyositis polymyositis

As listed by the trial registrant

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

Polymyositis, dermatomyositis

How to take part

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

The places running it

190 sites in 29 countries. The list below names each one and where it is.
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 ↗
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

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Phoenix, Arizona, 85032, United States
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Irvine, California, 92617, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80230, United States
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New Haven, Connecticut, 06519, United States
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Washington D.C., District of Columbia, 20037, United States
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Boca Raton, Florida, 33486, United States
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Boynton Beach, Florida, 33472, United States
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Gainesville, Florida, 32603, United States
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Margate, Florida, 33063, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Orlando, Florida, 32819, United States
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Palm Beach Gardens, Florida, 33410, United States
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Plant City, Florida, 33563, United States
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Atlanta, Georgia, 30322, United States
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Willowbrook, Illinois, 60527, United States
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Fairway, Kansas, 66205, United States
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Baltimore, Maryland, 21224, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48109, United States
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Sterling Heights, Michigan, 48313, United States
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Great Neck, New York, 11021, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28211, United States
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Durham, North Carolina, 27710, United States
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Cleveland, Ohio, 44195, United States
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Middleburg Heights, Ohio, 44130, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Charleston, South Carolina, 29425, United States
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Summerville, South Carolina, 29486, United States
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Allen, Texas, 75013, United States
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Amarillo, Texas, 79124, United States
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Austin, Texas, 78759, United States
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Colleyville, Texas, 76034, United States
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El Paso, Texas, 79902, United States
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Galveston, Texas, 77555, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77030, United States
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North Richland Hills, Texas, 76180, United States
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Beckley, West Virginia, 25801, United States
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Milwaukee, Wisconsin, 53226, United States
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Buenos Aires, C1180AAX, Argentina
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CABA, C1431FWO, Argentina
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Ciudad de Buenos Aires, C1405BCH, Argentina
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Quilmes, B1878GEG, Argentina
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San Miguel de Tucumán, T4000AXL, Argentina
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Camperdown, 2050, Australia
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Nedlands, 6009, Australia
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New Lambton, 2310, Australia
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Southport, 4222, Australia
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Woodville South, 5011, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Merksem, B-2170, Belgium
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Joinville, 89202-190, Brazil
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Juiz de Fora, 36010 570, Brazil
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Pelotas, 96040-010, Brazil
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Porto Alegre, 90620-110, Brazil
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Salvador, 40150-150, Brazil
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Salvador, 41253-190, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01233-907, Brazil
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São Paulo, 5403-000, Brazil
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Haskovo, 6304, Bulgaria
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Plovdiv, 4001, Bulgaria
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Plovdiv, 4002, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7000, Bulgaria
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Sofia, 1680, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Calgary, Alberta, T2N 4L7, Canada
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Calgary, Alberta, T3M1M4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Concepción, 4070022, Chile
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Las Condes, 7560908, Chile
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Osorno, 200025, Chile
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Santiago, 7691236, Chile
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Santiago, 8330034, Chile
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Santiago, 8420383, Chile
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Beijing, 100029, China
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Beijing, 100044, China
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Beijing, 100191, China
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Beijing, CN-100730, China
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Chongqing, 402260, China
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Dongguan, 523009, China
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Guangzhou, 510317, China
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Guangzhou, 510630, China
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Hangzhou, 310014, China
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Hengyang, 421001, China
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Jining, 272011, China
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Nanjing, 210029, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shanghai, China
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Shijiazhuang, 050001, China
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Wenzhou, 325000, China
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Zhengzhou, 450052, China
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Prague, 12850, Czechia
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Aarhus N, 8200, Denmark
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Copenhagen, 2100, Denmark
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Odense C, 5000, Denmark
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Angers, 49033, France
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Brest, 29609, France
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Le Mans, 72037, France
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Lille, 59037, France
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Lyon, 69437, France
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Paris, 75010, France
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Paris, 75651, France
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Reims, 51100, France
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Rouen, 76000, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Bad Nauheim, 61231, Germany
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Berlin, 10117, Germany
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Bonn, 53127, Germany
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Freiburg im Breisgau, 79106, Germany
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Herne, 44649, Germany
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München, 80336, Germany
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Tübingen, 72076, Germany
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Budapest, 1023, Hungary
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Debrecen, 4032, Hungary
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Szeged, 6725, Hungary
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Ahmedabad, 380006, India
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Ahmedabad, 382421, India
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Dehradun, 248016, India
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Delhi, 110029, India
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Gurugram, 122001, India
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Hyderabad, 500082, India
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Kolkata, 700020, India
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Lucknow, 226030, India
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Mumbai, 400 078, India
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Mumbai, 400012, India
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Mumbai, 400053, India
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Mysuru, 570004, India
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New Delhi, 110060, India
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Puducherry, 605006, India
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Secunderabad, 500003, India
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Afula, 18101, Israel
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Haifa, 31048, Israel
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Haifa, 34362, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Ramat Gan, 52621, Israel
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Ancona, 60126, Italy
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Bari, 70124, Italy
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Catania, 95100, Italy
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Milan, 20132, Italy
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Milan, 20161, Italy
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Padova, 35128, Italy
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Palermo, 90127, Italy
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Pavia, 27100, Italy
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Pisa, 56126, Italy
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Roma, 00128, Italy
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Roma, 00161, Italy
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Roma, 00189, Italy
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Rozzano, 20089, Italy
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Siena, 53100, Italy
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Asahikawa-Shi, 070-8644, Japan
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Chiba, 260-0877, Japan
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Fukuoka, 810-8563, Japan
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NOT_YET_RECRUITING

Hiroshima, 734-8551, Japan
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Iruma-Gun, 350-0495, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kawasaki-shi, 216-8511, Japan
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Nagoya, 457-0866, Japan
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Nagoya, 467-0001, Japan
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Okayama, 700-8557, Japan
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Omura-shi, 856-8562, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Tachikawa-shi, 190-0014, Japan
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Yotsukaido-shi, 284-0003, Japan
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Culiacán, 80020, Mexico
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D.F, 14000, Mexico
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Guadalajara, 44600, Mexico
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NOT_YET_RECRUITING

Guadalajara, 44650, Mexico
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Guadalajara, 44690, Mexico
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Mexico City, 03310, Mexico
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Mexico City, 06700, Mexico
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México, 06090, Mexico
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México, 11850, Mexico
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Amsterdam, 1105 AZ, Netherlands
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Bialystok, 15-276, Poland
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Krakow, 30-002, Poland
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Krakow, 30-105, Poland
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Lodz, 90-549, Poland
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Poznan, 60-218, Poland
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Poznan, 61-545, Poland
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Warsaw, 00-874, Poland
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Warsaw, 02-637, Poland
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Wroclaw, 50-556, Poland
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Caguas, 00725, Puerto Rico
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San Juan, 00918, Puerto Rico
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Daejeon, 35015, South Korea
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Seoul, 02447, South Korea
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Seoul, 04401, South Korea
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Seoul, 06591, South Korea
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Seoul, 133792, South Korea
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ACTIVE_NOT_RECRUITING

A Coruña, 15006, Spain
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08041, Spain
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Córdoba, 14004, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Sabadell, 08208, Spain
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Valladolid, 47012, Spain
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Stockholm, 171 76, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, 81362, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Edinburgh, EH4 2XU, United Kingdom
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London, NW3 2QG, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh City, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
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Huế, 530000, Vietnam