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Monoclonal Antibodies

INJECTION for Inflammatory Myopathies

Phase < 1
Waitlist Available
Led By Yessar Hussain, MD
Research Sponsored by Austin Neuromuscular Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 1. Age ≥45 years to 75 years of age 2. Diagnosed with sIBM based on the ENMC IBM Research Diagnostic Criteria 3. Willing and able to comply with clinic visits and study-related procedures. 4. Provide informed consent signed by the study patient or legally acceptable representative.
5. Able to understand and complete study-related questionnaires. 6. Able to ambulate at least 20 ft/6 meters with or without assistive device Once arising from the chair, the participant may use any walking device, i.e. walker/frame, cane, crutches, or braces. They cannot be supported by another person and cannot use furniture or walls for support.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from screening visit through week 104
Awards & highlights

Summary

To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM

Who is the study for?
This trial is for patients with sporadic Inclusion Body Myositis (sIBM), a muscle disease causing weakness and inflammation. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose additional risks.
What is being tested?
The trial is testing the effectiveness of combining two drugs, Pozelimab and Cemdisiran, in treating sIBM. The goal is to see if this combination therapy can improve symptoms or halt progression of the disease.
What are the potential side effects?
While specific side effects are not listed here, common ones for new therapies may include injection site reactions, flu-like symptoms, potential liver issues, allergic reactions, or other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from screening visit through week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from screening visit through week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IBM Physical Functioning Assessment (sIFA)
IBM-Functional Rating Scale (IBM-FRS)
Secondary study objectives
4-point Hopkins Falls Grading Scale (HFGS)
6 Minute Walk Test
Hand Grip Strength
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: INJECTIONExperimental Treatment1 Intervention
patients to receive Pozelimab 200mg/Cemdisiran 200 mg SC injections every 4 weeks for 104 weeks. SC injections will be administered by the study staff and the patient will be monitored for 30 minutes after the initial first injection. During the remainder of the study, injections can be administered at home by the patient or caregiver after injection training provided by the study staff. Designated persons will be observed to confirm their ability to perform the injections. The dosing window of the study treatment is within ±7 days from the scheduled dose date.

Find a Location

Who is running the clinical trial?

Austin Neuromuscular CenterLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
646 Previous Clinical Trials
383,962 Total Patients Enrolled
Yessar Hussain, MDPrincipal InvestigatorAustin Neuromuscular Center
~7 spots leftby May 2027
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