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Monoclonal Antibodies

Anifrolumab for Myositis (JASMINE Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 - 75 years old
No history of active tuberculosis or severe COVID-19
Must not have
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment
Any history of severe case of herpes zoster infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8, 24, & 52 week
Awards & highlights
Pivotal Trial

Summary

"This trial aims to see if anifrolumab is effective and safe for treating Idiopathic Inflammatory Myopathies (IIM) in patients with moderate to severe symptoms like polymyos

Who is the study for?
Adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically Polymyositis or Dermatomyositis, who are already on standard treatments can join. Details about specific inclusion and exclusion criteria are not provided here.
What is being tested?
The trial is testing the effectiveness and safety of Anifrolumab, given as a shot under the skin, compared to a placebo. Both will be added to usual care for IIM. It's randomized and double-blind, meaning neither participants nor researchers know who gets what during the study.
What are the potential side effects?
Possible side effects of Anifrolumab may include reactions at the injection site, increased risk of infections due to immune system suppression, and other potential immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have never had active tuberculosis or severe COVID-19.
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My weight is between 40 and 100 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was recently hospitalized or treated for a serious infection.
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I have had a severe case of shingles.
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My lung condition is getting worse quickly.
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I haven't been hospitalized for an infection needing IV drugs in the last 3 years.
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I haven't had CMV or EBV infections, or they've resolved over 12 weeks ago.
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I have a diagnosed muscle disease such as IBM, IMNM, juvenile myositis, or muscular dystrophy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8, 24, & 52 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8, 24, & 52 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Improvement Score (TIS) ≥ 40 response
Secondary study objectives
5-D itch
Core Set Measures (CSMs)
Cumulative Corticosteroid Use
+8 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anifrolumab (subcutaneous weekly injection)Experimental Treatment2 Interventions
Anifrolumab subcutaneous injection once weekly
Group II: Placebo (subcutaneous weekly injection)Placebo Group1 Intervention
Matched placebo control subcutaneous injection once weekly

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,485 Total Patients Enrolled
~160 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
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