What side effects are associated with this type of intervention?

Common treatments for inflammatory myositis include corticosteroids, immunosuppressants, biologics, and JAK inhibitors. Corticosteroids can cause side effects such as weight gain, osteoporosis, hypertension, and increased risk of infections. Immunosuppressants like methotrexate may lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Biologics, particularly TNF-alpha inhibitors, are associated with increased risk of infections, potential cardiovascular events, and injection site reactions. JAK inhibitors, such as tofacitinib, can cause venous thrombosis, pulmonary embolism, infections, and malignancies. These side effects should be carefully considered when choosing a treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for Inflammatory Myositis include immunosuppressive and immunomodulatory drugs such as methotrexate, azathioprine, and mycophenolate mofetil. These drugs are often used when patients do not respond adequately to corticosteroids. Additionally, biologic agents like rituximab, which targets B-cells, and intravenous immunoglobulin (IVIG) have been used for refractory cases. These treatments aim to reduce inflammation and modulate the immune response, similar to the objectives of the trial studying Daxdilimab.

What other types of research exist?

Promising novel alternatives to Daxdilimab for Inflammatory Myositis patients include: <ol> <li>Secukinumab - an IL-17A inhibitor, which has shown efficacy in conditions like psoriatic arthritis and ankylosing spondylitis.</li> <li></li> </ol> Tofacitinib - a Janus kinase (JAK) inhibitor, effective in psoriatic arthritis and other inflammatory conditions. 3. Ustekinumab - an IL-12/23 inhibitor, which has demonstrated benefits in psoriatic arthritis and other autoimmune diseases. These alternatives target specific inflammatory pathways and have shown promising results in clinical trials for related conditions.

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Monoclonal Antibodies

Daxdilimab for Inflammatory Myositis

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day1) to week 24

Summary

This trial is testing daxdilimab, a new medicine, to see if it can help patients with specific muscle and skin diseases by reducing inflammation and symptoms. The study focuses on patients with dermatomyositis or anti-synthetase inflammatory myositis.

Who is the study for?

This trial is for adults aged 18-75 with a diagnosis of dermatomyositis (DM) or anti-synthetase inflammatory myositis (ASIM), meeting specific criteria like muscle weakness and elevated muscle enzymes. Participants must not have severe infections, other connective tissue diseases that affect assessment, significant organ damage, or be pregnant. They should agree to potentially taper off corticosteroids.

What is being tested?

The study tests Daxdilimab's effectiveness compared to a placebo in reducing disease activity by week 24. It also looks at its impact on skin symptoms and the possibility of lowering corticosteroid use. Additionally, it will assess how the body processes the drug and any potential immune response to it.

What are the potential side effects?

While not explicitly listed here, common side effects may include reactions at the injection site, increased risk of infection due to immune system suppression, possible liver enzyme changes, fatigue, headache, and gastrointestinal issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day1) to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day1) to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day1) to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of daxdilimab compared to placebo as measured by Total Improvement Score (TIS)

Secondary study objectives

Change in the cutaneous dermatomyositis disease area and severity index (CDASI) activity score from Baseline (Day 1) to Week 24

Incidence of treatment emergent adverse events of special interest (TEAESIs)

Proportion of participants on an oral corticosteroid (OCS) dose ≥ 10 mg of prednisone or equivalent at baseline who achieve a clinically meaningful reduction in the OCS dose at Week 24

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DaxdilimabExperimental Treatment1 Intervention

Daxdilimab will be administered by subcutaneous (SC) injection over a total of 44 weeks.

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo will be administered by SC injection over a total of 24 weeks, then will be administered active drug by SC injection up to Week 44

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daxdilimab

2022

Completed Phase 2

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Inflammatory Myositis, such as infliximab, tacrolimus, and tofacitinib, work by modulating the immune system to reduce inflammation. Infliximab is an anti-TNF-alpha therapy that blocks tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation, thereby reducing immune response. Tofacitinib is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is crucial for the immune response. These mechanisms are important for patients with Inflammatory Myositis because they help to control the overactive immune response that leads to muscle inflammation and damage, thereby improving symptoms and quality of life.

Successful dose escalation of tofacitinib for refractory dermatomyositis and interstitial lung disease with anti-melanoma differentiation-associated gene 5 antibodies.A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.Efficacy of infliximab in the treatment for dermatomyositis with acute interstitial pneumonia: a study of fourteen cases and literature review.