A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) (JASMINE)

April 20, 2026 updated by: AstraZeneca

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

Study Overview

Status

Recruiting

Conditions

Polymyositis, Dermatomyositis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1180AAX
    - Recruiting
    - Research Site
  - CABA, Argentina, C1431FWO
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1405BCH
    - Recruiting
    - Research Site
  - Quilmes, Argentina, B1878GEG
    - Recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, T4000AXL
    - Recruiting
    - Research Site
Australia
- - Camperdown, Australia, 2050
    - Recruiting
    - Research Site
  - Nedlands, Australia, 6009
    - Recruiting
    - Research Site
  - New Lambton, Australia, 2310
    - Withdrawn
    - Research Site
  - Southport, Australia, 4222
    - Recruiting
    - Research Site
  - Woodville South, Australia, 5011
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
Belgium
- - Ghent, Belgium, 9000
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Merksem, Belgium, B-2170
    - Withdrawn
    - Research Site
Brazil
- - Joinville, Brazil, 89202-190
    - Recruiting
    - Research Site
  - Juiz de Fora, Brazil, 36010 570
    - Recruiting
    - Research Site
  - Pelotas, Brazil, 96040-010
    - Withdrawn
    - Research Site
  - Porto Alegre, Brazil, 90620-110
    - Recruiting
    - Research Site
  - Salvador, Brazil, 41253-190
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40150-150
    - Recruiting
    - Research Site
  - São José do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01233-907
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 5403-000
    - Not yet recruiting
    - Research Site
Bulgaria
- - Haskovo, Bulgaria, 6304
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4002
    - Withdrawn
    - Research Site
  - Plovdiv, Bulgaria, 4002
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4001
    - Recruiting
    - Research Site
  - Rousse, Bulgaria, 7000
    - Not yet recruiting
    - Research Site
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Withdrawn
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T3M1M4
    - Withdrawn
    - Research Site
  - Calgary, Alberta, Canada, T2N 4L7
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Research Site
Chile
- - Concepción, Chile, 4070022
    - Recruiting
    - Research Site
  - Las Condes, Chile, 7560908
    - Recruiting
    - Research Site
  - Osorno, Chile, 200025
    - Recruiting
    - Research Site
  - Santiago, Chile, 8420383
    - Withdrawn
    - Research Site
  - Santiago, Chile, 8330034
    - Recruiting
    - Research Site
  - Santiago, Chile, 7691236
    - Withdrawn
    - Research Site
China
- - Beijing, China, 100191
    - Recruiting
    - Research Site
  - Beijing, China, 100029
    - Recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Recruiting
    - Research Site
  - Beijing, China, 100044
    - Withdrawn
    - Research Site
  - Chongqing, China, 402260
    - Recruiting
    - Research Site
  - Dongguan, China, 523009
    - Recruiting
    - Research Site
  - Guangzhou, China, 510630
    - Recruiting
    - Research Site
  - Guangzhou, China, 510317
    - Recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Recruiting
    - Research Site
  - Hengyang, China, 421001
    - Recruiting
    - Research Site
  - Jining, China, 272011
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 200040
    - Recruiting
    - Research Site
  - Shanghai, China
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 050001
    - Recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450052
    - Recruiting
    - Research Site
Czechia
- - Prague, Czechia, 12850
    - Recruiting
    - Research Site
Denmark
- - Aarhus N, Denmark, 8200
    - Recruiting
    - Research Site
  - Copenhagen, Denmark, 2100
    - Withdrawn
    - Research Site
  - Odense C, Denmark, 5000
    - Recruiting
    - Research Site
France
- - Angers, France, 49033
    - Recruiting
    - Research Site
  - Brest, France, 29609
    - Recruiting
    - Research Site
  - Le Mans, France, 72037
    - Recruiting
    - Research Site
  - Lille, France, 59037
    - Recruiting
    - Research Site
  - Lyon, France, 69437
    - Recruiting
    - Research Site
  - Paris, France, 75010
    - Recruiting
    - Research Site
  - Paris, France, 75651
    - Recruiting
    - Research Site
  - Reims, France, 51100
    - Recruiting
    - Research Site
  - Rouen, France, 76000
    - Recruiting
    - Research Site
  - Strasbourg, France, 67098
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Recruiting
    - Research Site
Germany
- - Bad Nauheim, Germany, 61231
    - Withdrawn
    - Research Site
  - Berlin, Germany, 10117
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Research Site
  - Herne, Germany, 44649
    - Not yet recruiting
    - Research Site
  - München, Germany, 80336
    - Recruiting
    - Research Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1023
    - Not yet recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Research Site
  - Szeged, Hungary, 6725
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 380006
    - Withdrawn
    - Research Site
  - Ahmedabad, India, 382421
    - Withdrawn
    - Research Site
  - Dehradun, India, 248016
    - Withdrawn
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Gurugram, India, 122001
    - Withdrawn
    - Research Site
  - Hyderabad, India, 500082
    - Recruiting
    - Research Site
  - Kolkata, India, 700020
    - Recruiting
    - Research Site
  - Lucknow, India, 226030
    - Recruiting
    - Research Site
  - Mumbai, India, 400012
    - Withdrawn
    - Research Site
  - Mumbai, India, 400053
    - Recruiting
    - Research Site
  - Mumbai, India, 400 078
    - Withdrawn
    - Research Site
  - Mysuru, India, 570004
    - Recruiting
    - Research Site
  - New Delhi, India, 110060
    - Withdrawn
    - Research Site
  - Puducherry, India, 605006
    - Withdrawn
    - Research Site
  - Secunderabad, India, 500003
    - Recruiting
    - Research Site
Israel
- - Afula, Israel, 18101
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Haifa, Israel, 31048
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91120
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
Italy
- - Ancona, Italy, 60126
    - Recruiting
    - Research Site
  - Bari, Italy, 70124
    - Recruiting
    - Research Site
  - Catania, Italy, 95100
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Recruiting
    - Research Site
  - Milan, Italy, 20161
    - Withdrawn
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Palermo, Italy, 90127
    - Withdrawn
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - Pisa, Italy, 56126
    - Withdrawn
    - Research Site
  - Roma, Italy, 00161
    - Withdrawn
    - Research Site
  - Roma, Italy, 00189
    - Recruiting
    - Research Site
  - Roma, Italy, 00128
    - Withdrawn
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Siena, Italy, 53100
    - Suspended
    - Research Site
Japan
- - Asahikawa-Shi, Japan, 070-8644
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8603
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8431
    - Not yet recruiting
    - Research Site
  - Chiba, Japan, 260-0877
    - Withdrawn
    - Research Site
  - Fukuoka, Japan, 810-8563
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Not yet recruiting
    - Research Site
  - Iruma-Gun, Japan, 350-0495
    - Recruiting
    - Research Site
  - Kawachinagano-shi, Japan, 586-8521
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Recruiting
    - Research Site
  - Nagoya, Japan, 457-0866
    - Recruiting
    - Research Site
  - Nagoya, Japan, 467-0001
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8557
    - Recruiting
    - Research Site
  - Omura-shi, Japan, 856-8562
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Tachikawa-shi, Japan, 190-0014
    - Recruiting
    - Research Site
  - Yotsukaido-shi, Japan, 284-0003
    - Recruiting
    - Research Site
Mexico
- - Culiacán, Mexico, 80020
    - Recruiting
    - Research Site
  - D.F, Mexico, 14000
    - Withdrawn
    - Research Site
  - Guadalajara, Mexico, 44650
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44600
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44690
    - Recruiting
    - Research Site
  - Mexico City, Mexico, 03310
    - Recruiting
    - Research Site
  - Mexico City, Mexico, 06700
    - Recruiting
    - Research Site
  - México, Mexico, 06090
    - Withdrawn
    - Research Site
  - México, Mexico, 11850
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-276
    - Withdrawn
    - Research Site
  - Krakow, Poland, 30-002
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-721
    - Recruiting
    - Research Site
  - Lodz, Poland, 90-549
    - Recruiting
    - Research Site
  - Poznan, Poland, 61-545
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-218
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-637
    - Recruiting
    - Research Site
  - Warsaw, Poland, 00-874
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-556
    - Recruiting
    - Research Site
Puerto Rico
- - Caguas, Puerto Rico, 00725
    - Recruiting
    - Research Site
  - San Juan, Puerto Rico, 00918
    - Recruiting
    - Research Site
South Korea
- - Daejeon, South Korea, 35015
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 02447
    - Recruiting
    - Research Site
  - Seoul, South Korea, 04401
    - Recruiting
    - Research Site
  - Seoul, South Korea, 133792
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Active, not recruiting
    - Research Site
  - Barcelona, Spain, 08041
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08003
    - Recruiting
    - Research Site
  - Córdoba, Spain, 14004
    - Recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Sabadell, Spain, 08208
    - Recruiting
    - Research Site
  - Valladolid, Spain, 47012
    - Recruiting
    - Research Site
Sweden
- - Stockholm, Sweden, 171 76
    - Withdrawn
    - Research Site
  - Uppsala, Sweden, 751 85
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 81362
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Terminated
    - Research Site
  - Taipei, Taiwan, 112
    - Withdrawn
    - Research Site
  - Taoyuan District, Taiwan, 333
    - Withdrawn
    - Research Site
United Kingdom
- - Edinburgh, United Kingdom, EH4 2XU
    - Recruiting
    - Research Site
  - London, United Kingdom, NW3 2QG
    - Recruiting
    - Research Site
  - Wolverhampton, United Kingdom, WV10 0QP
    - Recruiting
    - Research Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85032
    - Not yet recruiting
    - Research Site
- California
  - Irvine, California, United States, 92617
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
  - Denver, Colorado, United States, 80230
    - Not yet recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Withdrawn
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Research Site
  - Boynton Beach, Florida, United States, 33472
    - Withdrawn
    - Research Site
  - Gainesville, Florida, United States, 32603
    - Withdrawn
    - Research Site
  - Margate, Florida, United States, 33063
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33126
    - Withdrawn
    - Research Site
  - Miami, Florida, United States, 33133
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32819
    - Recruiting
    - Research Site
  - Palm Beach Gardens, Florida, United States, 33410
    - Recruiting
    - Research Site
  - Plant City, Florida, United States, 33563
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Research Site
- Illinois
  - Willowbrook, Illinois, United States, 60527
    - Recruiting
    - Research Site
- Kansas
  - Fairway, Kansas, United States, 66205
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Not yet recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - Research Site
  - Sterling Heights, Michigan, United States, 48313
    - Not yet recruiting
    - Research Site
- New York
  - Great Neck, New York, United States, 11021
    - Not yet recruiting
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Withdrawn
    - Research Site
  - Charlotte, North Carolina, United States, 28211
    - Recruiting
    - Research Site
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Research Site
  - Middleburg Heights, Ohio, United States, 44130
    - Withdrawn
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Research Site
  - Summerville, South Carolina, United States, 29486
    - Recruiting
    - Research Site
- Texas
  - Allen, Texas, United States, 75013
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78759
    - Not yet recruiting
    - Research Site
  - Colleyville, Texas, United States, 76034
    - Recruiting
    - Research Site
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Research Site
  - Galveston, Texas, United States, 77555
    - Withdrawn
    - Research Site
  - Harlingen, Texas, United States, 78550
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77030
    - Withdrawn
    - Research Site
  - North Richland Hills, Texas, United States, 76180
    - Recruiting
    - Research Site
- West Virginia
  - Beckley, West Virginia, United States, 25801
    - Not yet recruiting
    - Research Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 10000
    - Withdrawn
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Hochiminh City, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Huế, Vietnam, 530000
    - Recruiting
    - Research Site
  - Hà Nội, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hà Nội, Vietnam, 100000
    - Withdrawn
    - Research Site
  - Hồ Chí Minh, Vietnam, 700000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Capable of giving informed consent.

Inclusion Criteria:

18 - 75 years old
Body weight ≥40 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
No history of active tuberculosis or severe COVID-19.
Male and female participants must follow contraception guidelines.

Exclusion Criteria:

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).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
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.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anifrolumab (subcutaneous weekly injection) Anifrolumab subcutaneous injection once weekly	Combination product: Anifrolumab (blinded) Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks Other Names: Treatment arm (blinded) Combination product: Anifrolumab (unblinded, open label) At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks Other Names: treatment arm (unblinded)
Placebo Comparator: Placebo (subcutaneous weekly injection) Matched placebo control subcutaneous injection once weekly	Other: Placebo Matched placebo delivered subcutaneously, once weekly for 52 weeks Other Names: Placebo arm (blinded)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Improvement Score (TIS) ≥ 40 response Time Frame: 52 week	Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits	52 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Set Measures (CSMs) Time Frame: 52 week	Change from baseline at Week 52 in CSMs: PGA PtGA Muscle enzymes MDAAT extra-muscular disease activity HAQ-DI	52 week
Cumulative Corticosteroid Use Time Frame: 24, 52 week	Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 24 Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 52	24, 52 week
Manual Muscle Testing 8 (MMT-8) (CSM) Time Frame: 52 week	MMT-8 (CSM) change from baseline at Week 52.	52 week
Oral corticosteroid dose ≤ 7.5 mg/day Time Frame: 52 week	Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.	52 week
Moderate improvement in disease activity in participants with polymyositis (PM) Time Frame: 52 week	Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52.	52 week
Moderate improvement in disease activity in dermatomyositis (DM) participants. Time Frame: 52 week	Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40).	52 week
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Time Frame: 8 week	CDASI activity change from baseline at Week 8 in DM participants only.	8 week
Manual Muscle Testing 8 (MMT-8) in PM participants Time Frame: 52 Week	MMT-8 change from baseline at Week 52 in PM participants only.	52 Week
Manual Muscle Testing 8 (MMT-8) in DM participants Time Frame: 52 Week	MMT-8 change from baseline at Week 52 in DM participants only.	52 Week
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants Time Frame: 52 week	PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52	52 week
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants Time Frame: 52 week	DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.	52 week
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA) Time Frame: 8, 24, & 52 week	DM Participants with CDA-IGA ≥ 2 at baseline who achieve: CDA-IGA score ≤ 1 at Week 8 (yes/no) CDA-IGA score ≤ 1 at Week 24 (yes/no) CDA-IGA score ≤ 1 at Week 52 (yes/no)	8, 24, & 52 week
5-D itch Time Frame: 8, 24, & 52 week	DM participants with CDASI activity > 14 at baseline only: 5-D itch change from baseline at Week 8 5-D itch change from baseline at Week 24 5-D itch change from baseline at Week 52	8, 24, & 52 week
Total Improvement Score (TIS) ≥ 20 Response Time Frame: 8 week	Participants who have at least minimal improvement in disease activity TIS ≥ 20 at Week 8 and has not met "confirmed deterioration" criteria at 2 consecutive visits up and including Week 8	8 week
Total Improvement Score ≥ 60 Response Time Frame: 52 week	Participants who have major improvement in disease activity TIS ≥ 60 at week 52 and has not met "confirmed deterioration" criteria at 2 consecutive visits up to and including Week 52	52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Soares RB, Gabr JB, Ash M, Hosler G. Anifrolumab in Refractory Dermatomyositis and Antisynthetase Syndrome. Case Rep Rheumatol. 2025 Apr 21;2025:5560523. doi: 10.1155/crrh/5560523. eCollection 2025.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

May 14, 2027

Study Completion (Estimated)

August 4, 2028

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D3463C00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Polymyositis, Dermatomyositis

Clinical Trials on Anifrolumab (blinded)

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