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
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)
1 other identifier
interventional
240
28 countries
229
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2024
Typical duration for phase_3
229 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
June 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2028
April 21, 2026
April 1, 2026
2.9 years
September 28, 2023
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Improvement Score (TIS) ≥ 40 response
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 Outcomes (15)
Manual Muscle Testing 8 (MMT-8) (CSM)
52 week
Oral corticosteroid dose ≤ 7.5 mg/day
52 week
Moderate improvement in disease activity in participants with polymyositis (PM)
52 week
Moderate improvement in disease activity in dermatomyositis (DM) participants.
52 week
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
8 week
- +10 more secondary outcomes
Study Arms (2)
Anifrolumab (subcutaneous weekly injection)
EXPERIMENTALAnifrolumab subcutaneous injection once weekly
Placebo (subcutaneous weekly injection)
PLACEBO COMPARATORMatched placebo control subcutaneous injection once weekly
Interventions
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (234)
Research Site
Phoenix, Arizona, 85032, United States
Research Site
Irvine, California, 92617, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
New Haven, Connecticut, 06519, United States
Research Site
Washington D.C., District of Columbia, 20037, United States
Research Site
Boca Raton, Florida, 33486, United States
Research Site
Boynton Beach, Florida, 33472, United States
Research Site
Gainesville, Florida, 32603, United States
Research Site
Margate, Florida, 33063, United States
Research Site
Miami, Florida, 33126, United States
Research Site
Miami, Florida, 33133, United States
Research Site
Orlando, Florida, 32819, United States
Research Site
Palm Beach Gardens, Florida, 33410, United States
Research Site
Plant City, Florida, 33563, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Willowbrook, Illinois, 60527, United States
Research Site
Fairway, Kansas, 66205, United States
Research Site
Baltimore, Maryland, 21224, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Sterling Heights, Michigan, 48313, United States
Research Site
Great Neck, New York, 11021, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Charlotte, North Carolina, 28211, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Middleburg Heights, Ohio, 44130, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Pittsburgh, Pennsylvania, 15213, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Summerville, South Carolina, 29486, United States
Research Site
Allen, Texas, 75013, United States
Research Site
Austin, Texas, 78759, United States
Research Site
Colleyville, Texas, 76034, United States
Research Site
El Paso, Texas, 79902, United States
Research Site
Galveston, Texas, 77555, United States
Research Site
Harlingen, Texas, 78550, United States
Research Site
Houston, Texas, 77030, United States
Research Site
North Richland Hills, Texas, 76180, United States
Research Site
Beckley, West Virginia, 25801, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Buenos Aires, C1180AAX, Argentina
Research Site
CABA, C1431FWO, Argentina
Research Site
Ciudad de Buenos Aires, C1405BCH, Argentina
Research Site
Quilmes, B1878GEG, Argentina
Research Site
San Miguel de Tucumán, T4000AXL, Argentina
Research Site
Camperdown, 2050, Australia
Research Site
Nedlands, 6009, Australia
Research Site
New Lambton, 2310, Australia
Research Site
Southport, 4222, Australia
Research Site
Woodville South, 5011, Australia
Research Site
Graz, 8036, Austria
Research Site
Vienna, 1090, Austria
Research Site
Ghent, 9000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Merksem, B-2170, Belgium
Research Site
Joinville, 89202-190, Brazil
Research Site
Juiz de Fora, 36010 570, Brazil
Research Site
Pelotas, 96040-010, Brazil
Research Site
Porto Alegre, 90620-110, Brazil
Research Site
Salvador, 40150-150, Brazil
Research Site
Salvador, 41253-190, Brazil
Research Site
São José do Rio Preto, 15090-000, Brazil
Research Site
São Paulo, 01233-907, Brazil
Research Site
São Paulo, 5403-000, Brazil
Research Site
Haskovo, 6304, Bulgaria
Research Site
Plovdiv, 4001, Bulgaria
Research Site
Plovdiv, 4002, Bulgaria
Research Site
Plovdiv, 4002, Bulgaria
Research Site
Rousse, 7000, Bulgaria
Research Site
Sofia, 1680, Bulgaria
Research Site
Stara Zagora, 6003, Bulgaria
Research Site
Calgary, Alberta, T2N 4L7, Canada
Research Site
Calgary, Alberta, T3M1M4, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Concepción, 4070022, Chile
Research Site
Las Condes, 7560908, Chile
Research Site
Osorno, 200025, Chile
Research Site
Santiago, 7691236, Chile
Research Site
Santiago, 8330034, Chile
Research Site
Santiago, 8420383, Chile
Research Site
Beijing, 100029, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100191, China
Research Site
Beijing, CN-100730, China
Research Site
Chongqing, 402260, China
Research Site
Dongguan, 523009, China
Research Site
Guangzhou, 510317, China
Research Site
Guangzhou, 510630, China
Research Site
Hangzhou, 310014, China
Research Site
Hengyang, 421001, China
Research Site
Jining, 272011, China
Research Site
Nanjing, 210029, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200040, China
Research Site
Shanghai, China
Research Site
Shijiazhuang, 050001, China
Research Site
Wenzhou, 325000, China
Research Site
Zhengzhou, 450052, China
Research Site
Prague, 12850, Czechia
Research Site
Aarhus N, 8200, Denmark
Research Site
Copenhagen, 2100, Denmark
Research Site
Odense C, 5000, Denmark
Research Site
Angers, 49033, France
Research Site
Brest, 29609, France
Research Site
Le Mans, 72037, France
Research Site
Lille, 59037, France
Research Site
Lyon, 69437, France
Research Site
Paris, 75010, France
Research Site
Paris, 75651, France
Research Site
Reims, 51100, France
Research Site
Rouen, 76000, France
Research Site
Strasbourg, 67098, France
Research Site
Toulouse, 31059, France
Research Site
Bad Nauheim, 61231, Germany
Research Site
Berlin, 10117, Germany
Research Site
Bonn, 53127, Germany
Research Site
Freiburg im Breisgau, 79106, Germany
Research Site
Herne, 44649, Germany
Research Site
München, 80336, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Budapest, 1023, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Szeged, 6725, Hungary
Research Site
Ahmedabad, 380006, India
Research Site
Ahmedabad, 382421, India
Research Site
Dehradun, 248016, India
Research Site
Delhi, 110029, India
Research Site
Gurugram, 122001, India
Research Site
Hyderabad, 500082, India
Research Site
Kolkata, 700020, India
Research Site
Lucknow, 226030, India
Research Site
Mumbai, 400 078, India
Research Site
Mumbai, 400012, India
Research Site
Mumbai, 400053, India
Research Site
Mysuru, 570004, India
Research Site
New Delhi, 110060, India
Research Site
Puducherry, 605006, India
Research Site
Secunderabad, 500003, India
Research Site
Afula, 18101, Israel
Research Site
Haifa, 31048, Israel
Research Site
Haifa, 34362, Israel
Research Site
Jerusalem, 91120, Israel
Research Site
Kfar Saba, 4428164, Israel
Research Site
Ramat Gan, 52621, Israel
Research Site
Ancona, 60126, Italy
Research Site
Bari, 70124, Italy
Research Site
Catania, 95100, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20161, Italy
Research Site
Padova, 35128, Italy
Research Site
Palermo, 90127, Italy
Research Site
Pavia, 27100, Italy
Research Site
Pisa, 56126, Italy
Research Site
Roma, 00128, Italy
Research Site
Roma, 00161, Italy
Research Site
Roma, 00189, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Siena, 53100, Italy
Research Site
Asahikawa-Shi, 070-8644, Japan
Research Site
Bunkyō City, 113-8431, Japan
Research Site
Bunkyō City, 113-8603, Japan
Research Site
Chiba, 260-0877, Japan
Research Site
Fukuoka, 810-8563, Japan
Research Site
Hiroshima, 734-8551, Japan
Research Site
Iruma-Gun, 350-0495, Japan
Research Site
Kawachinagano-shi, 586-8521, Japan
Research Site
Kawasaki-shi, 216-8511, Japan
Research Site
Nagoya, 457-0866, Japan
Research Site
Nagoya, 467-0001, Japan
Research Site
Okayama, 700-8557, Japan
Research Site
Omura-shi, 856-8562, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Shinjuku-ku, 160-8582, Japan
Research Site
Tachikawa-shi, 190-0014, Japan
Research Site
Yotsukaido-shi, 284-0003, Japan
Research Site
Culiacán, 80020, Mexico
Research Site
D.F, 14000, Mexico
Research Site
Guadalajara, 44600, Mexico
Research Site
Guadalajara, 44650, Mexico
Research Site
Guadalajara, 44690, Mexico
Research Site
Mexico City, 03310, Mexico
Research Site
Mexico City, 06700, Mexico
Research Site
México, 06090, Mexico
Research Site
México, 11850, Mexico
Research Site
Amsterdam, 1105 AZ, Netherlands
Research Site
Bialystok, 15-276, Poland
Research Site
Krakow, 30-002, Poland
Research Site
Krakow, 30-721, Poland
Research Site
Lodz, 90-549, Poland
Research Site
Poznan, 60-218, Poland
Research Site
Poznan, 61-545, Poland
Research Site
Warsaw, 00-874, Poland
Research Site
Warsaw, 02-637, Poland
Research Site
Wroclaw, 50-556, Poland
Research Site
Caguas, 00725, Puerto Rico
Research Site
San Juan, 00918, Puerto Rico
Research Site
Daejeon, 35015, South Korea
Research Site
Seoul, 02447, South Korea
Research Site
Seoul, 04401, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 133792, South Korea
Research Site
A Coruña, 15006, Spain
Research Site
Barcelona, 08003, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08041, Spain
Research Site
Córdoba, 14004, Spain
Research Site
L'Hospitalet de Llobregat, 08907, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Sabadell, 08208, Spain
Research Site
Valladolid, 47012, Spain
Research Site
Stockholm, 171 76, Sweden
Research Site
Uppsala, 751 85, Sweden
Research Site
Kaohsiung City, 81362, Taiwan
Research Site
Kaohsiung City, 833, Taiwan
Research Site
New Taipei City, 220, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Edinburgh, EH4 2XU, United Kingdom
Research Site
London, NW3 2QG, United Kingdom
Research Site
Wolverhampton, WV10 0QP, United Kingdom
Research Site
Hanoi, 100000, Vietnam
Research Site
Hanoi, 10000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Hochiminh City, 700000, Vietnam
Research Site
Hồ Chí Minh, 700000, Vietnam
Research Site
Huế, 530000, Vietnam
Related Publications (1)
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.
PMID: 40297385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
June 12, 2024
Study Start
June 20, 2024
Primary Completion (Estimated)
May 14, 2027
Study Completion (Estimated)
August 4, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- 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.
- 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.
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.