Anifrolumab for Myositis

(JASMINE Trial)

Recruiting in Palo Alto (17 mi)

+138 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AstraZeneca

Must be taking: Prednisone, others

Disqualifiers: Inclusion body myositis, Cancer, HIV, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, participants must be on a stable dose of treatments like oral prednisone for polymyositis or dermatomyositis.

What data supports the effectiveness of the drug Anifrolumab for treating myositis?

Anifrolumab has been shown to be effective in treating systemic lupus erythematosus (SLE), an autoimmune condition, by targeting the type I interferon receptor, which is involved in the disease process. This suggests it might also help with other autoimmune conditions like myositis, although direct evidence for myositis is not provided. ^{1 2 3 4 5}

Is anifrolumab safe for humans?

Anifrolumab has been studied for safety in patients with systemic lupus erythematosus (SLE), showing some risk of viral infections like varicella zoster (chickenpox) and possibly influenza. It is generally considered safe, but patients should be monitored for these infections. ^{5 6 7 8 9}

How is the drug Anifrolumab unique in treating myositis?

Anifrolumab is unique because it targets the type I interferon receptor, which is involved in autoimmune conditions like systemic lupus erythematosus (SLE). This mechanism of action is different from other treatments for myositis, which may not specifically target this pathway. ^{2 3 5 10 11}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.

My weight is between 40 and 100 kg.

Must have 'probable' or 'definite' diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis

Exclusion Criteria

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

I am at high risk for cancer due to my muscle condition.

I was recently hospitalized or treated for a serious infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous anifrolumab or placebo weekly, added to standard of care, to evaluate efficacy and safety in idiopathic inflammatory myopathies

52 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anifrolumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Anifrolumab (subcutaneous weekly injection) Experimental Treatment 2 Interventions

Anifrolumab subcutaneous injection once weekly

Group II: Placebo (subcutaneous weekly injection) Placebo Group 1 Intervention

Matched placebo control subcutaneous injection once weekly

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Irvine, CA

Research Site Cleveland, OH

Research Site Montreal, Canada

Research Site Orlando, FL

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a study of six female patients with myositis who did not respond to conventional immunosuppressive therapies, mycophenolate mofetil (MMF) was found to be effective in improving muscle strength and reducing creatine kinase (CK) levels over an average treatment duration of 22.3 months.

Patients experienced a significant reduction in their prednisolone dosage from an average of 13.7 mg to 8.5 mg per day, indicating that MMF may help manage myositis symptoms while allowing for lower doses of corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil treatment in resistant myositis. Pisoni, CN., Cuadrado, MJ., Khamashta, MA., et al.[2022]

Anifrolumab is a monoclonal antibody that targets the type 1 interferon receptor and has been approved in the USA for treating moderate to severe systemic lupus erythematosus (SLE) in adults, marking a significant advancement in autoimmune disorder therapies.

The drug is currently being evaluated in ongoing clinical studies and is under regulatory review in the EU and Japan, indicating its potential for broader use in managing SLE and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab: First Approval. Deeks, ED.[2022]

Serum levels of B cell activating factor (BAFF) were significantly higher in patients with myositis compared to healthy controls, suggesting a potential role in the disease's pathology.

Higher BAFF levels were associated with specific autoantibodies, particularly anti-Jo-1, and correlated with muscle damage markers, indicating that BAFF may serve as a therapeutic target in myositis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased serum levels of B cell activating factor (BAFF) in subsets of patients with idiopathic inflammatory myopathies. Krystufková, O., Vallerskog, T., Helmers, SB., et al.[2009]

In a phase IIb trial involving 305 patients with moderate-to-severe systemic lupus erythematosus (SLE), anifrolumab significantly improved disease activity compared to placebo, particularly in patients with a high interferon gene signature, with 34.3% of patients on the 300 mg dose achieving a response at week 24.

Anifrolumab's safety profile was generally similar to placebo, but it was associated with a higher incidence of herpes zoster and influenza-like symptoms, indicating a need for monitoring these potential side effects in treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. Loncharich, MF., Anderson, CW.[2022]

In a pooled analysis of 925 patients with moderate to severe systemic lupus erythematosus (SLE), anifrolumab (300 mg monthly) was generally well tolerated over 52 weeks, showing an acceptable safety profile.

While anifrolumab was associated with a higher incidence of herpes zoster and respiratory infections compared to placebo, it also had a lower rate of serious adverse events related to SLE exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials. Tummala, R., Abreu, G., Pineda, L., et al.[2021]

In a phase 3 trial involving 362 patients with systemic lupus erythematosus, anifrolumab (300 mg) administered monthly showed a significant improvement in patient responses compared to placebo, with 47.8% of patients achieving a BICLA response versus 31.5% for placebo (P = 0.001).

While anifrolumab demonstrated efficacy in reducing disease activity and glucocorticoid use, it was associated with a higher incidence of herpes zoster (7.2%) and bronchitis (12.2%), highlighting the need for monitoring safety alongside its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Anifrolumab in Active Systemic Lupus Erythematosus. Morand, EF., Furie, R., Tanaka, Y., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil treatment in resistant myositis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Anifrolumab: First Approval. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Increased serum levels of B cell activating factor (BAFF) in subsets of patients with idiopathic inflammatory myopathies. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Tocilizumab in the Treatment of Refractory Adult Polymyositis and Dermatomyositis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exposure-response analysis for selection of optimal dosage regimen of anifrolumab in patients with systemic lupus erythematosus. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Trial of Anifrolumab in Active Systemic Lupus Erythematosus. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The use of ELISA is comparable to immunoprecipitation in the detection of selected myositis-specific autoantibodies in a European population. [2022]