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Monoclonal Antibodies

Canakinumab for Duchenne Muscular Dystrophy

Phase 1 & 2

Waitlist Available

Led By Christopher Spurney

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

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

Must have

Subject has a diagnosis of DMD

Subject is naïve to treatment with glucocorticoids for DMD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial is investigating the effects of canakinumab, an anti-interleukin 1 beta (IL1β) antibody, on clinical safety and potential clinical efficacy in young boys with Duchenne Muscular Dystrophy (DMD) who are most likely to have high levels of muscle inflammation.

Who is the study for?

This trial is for young boys with Duchenne Muscular Dystrophy (DMD) who are between 2 to less than 6 years old, have not been treated with steroids, and can walk. They should have normal or acceptable lab test results and no major organ issues, diabetes, immunosuppression, recent infections or vaccinations. They must not be on other investigational drugs or have had certain treatments within the past 3 months.Check my eligibility

What is being tested?

The trial tests Canakinumab Injection [Ilaris], an antibody against interleukin-1 beta (IL1β), for safety and potential efficacy in reducing muscle inflammation in DMD patients. Participants will receive a single subcutaneous dose of Canakinumab and will be monitored over 30 days for changes in serum biomarkers related to inflammation.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infection due to immune system suppression by the drug, abnormal blood test results reflecting liver or kidney function issues, allergic reactions including fever syndromes as seen in conditions where Canakinumab is already used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Duchenne Muscular Dystrophy (DMD).

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I have not taken glucocorticoids for Duchenne Muscular Dystrophy.

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I can walk on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical adverse events

Laboratory adverse events

Secondary outcome measures

Changes in serum biomarkers of inflammation after treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Canakinumab treatment

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,154 Total Patients Enrolled

Foundation to Eradicate DuchenneUNKNOWN

Christopher SpurneyPrincipal Investigator - Children's National Research Institute

Children's National Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me about other studies that have used Canakinumab Injection [Ilaris]?

"As of right now, there are 16 clinical trials studying Canakinumab Injection [Ilaris], with 3 being in Phase 3. Even though a few of the studies for Canakinumab Injection [Ilaris] will soon finish in Houston, Texas, 598 other places across the globe are still running tests."

Answered by AI

What indications is Canakinumab Injection [Ilaris] commonly used to treat?

"Canakinumab Injection [Ilaris] is an effective therapy for patients with muckle-wells syndrome, active systemic juvenile idiopathic arthritis, or neonatal-onset multisystem inflammatory disease."

Answered by AI

How many patients are being monitored in this clinical trial?

"That is correct. The information available on clinicaltrials.gov reveals that this study is presently looking for candidates. This particular clinical trial was originally posted on 5/1/2019 and was last updated on 3/1/2022. They are recruiting for 6 participants across 1 locations"

Answered by AI

Can new participants still join the research project?

"That is accurate, the clinical trial detailed on clinicaltrials.gov is recruiting patients as of now. Originally appearing on May 1st 2019, with the most recent update being March 1st 2022, the study needs 6 more participants and is being conducted at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) in Duchenne Muscular Dystrophy

Christopher Spurney 2019. "Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) in Duchenne Muscular Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03936894.

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