A Phase 3 interventional study of Anifrolumab (blinded) and Placebo in Polymyositis, Dermatomyositis, sponsored by AstraZeneca. Recruiting at 237 sites in 29 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's planned enrollment of 240 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Capable of giving .
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anifrolumab subcutaneous injection once weekly
Combination Product: Anifrolumab (blinded) · Combination Product: Anifrolumab (unblinded, open label)
Matched placebo control subcutaneous injection once weekly
Other: Placebo
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Also known as: Treatment arm (blinded)
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Also known as: Placebo arm (blinded)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Also known as: treatment arm (unblinded)
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
Time frame: 52 week
Manual Muscle Testing 8 (MMT-8) (CSM)
MMT-8 (CSM) change from baseline at Week 52.
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day
Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Time frame: 52 week
Moderate improvement in disease activity in participants with polymyositis (PM)
Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52.
Time frame: 52 week
Moderate improvement in disease activity in dermatomyositis (DM) participants.
Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40).
Time frame: 52 week
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
CDASI activity change from baseline at Week 8 in DM participants only.
Time frame: 8 week
Manual Muscle Testing 8 (MMT-8) in PM participants
MMT-8 change from baseline at Week 52 in PM participants only.
Time frame: 52 Week
Manual Muscle Testing 8 (MMT-8) in DM participants
MMT-8 change from baseline at Week 52 in DM participants only.
Time frame: 52 Week
Core Set Measures (CSMs)
Change from baseline at Week 52 in CSMs: * PGA * PtGA * Muscle enzymes * MDAAT extra-muscular disease activity * HAQ-DI
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants
PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants
DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Time frame: 52 week
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
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)
Time frame: 8, 24, & 52 week
5-D itch
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
Time frame: 8, 24, & 52 week
Total Improvement Score (TIS) ≥ 20 Response
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
Time frame: 8 week
Total Improvement Score ≥ 60 Response
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
Time frame: 52 week
Cumulative Corticosteroid Use
* 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
Time frame: 24, 52 week
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Showing the first 100 of 237 sites across 29 countries. Choose a country and city above to see the rest.
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan
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.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
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Studies of the drug tested here: Anifrolumab