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Monoclonal Antibodies

Pozelimab + Cemdisiran for Inclusion Body Myositis

Phase < 1

Recruiting

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

Able to ambulate at least 20 ft/6 meters with or without assistive device

Female subjects must meet specific sterilization criteria or use approved birth control methods

Must not have

Other neurological conditions or musculoskeletal conditions causing mobility impairment

Known active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from screening visit through week 104

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test how well a combination of Pozelimab and Cemdisiran works 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

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I can walk at least 20 feet with or without help.

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I am using approved birth control or meet sterilization criteria.

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I am a male and either had a vasectomy, use birth control, or do not have sex.

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I am between 45 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition affecting my movement.

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I have an active cancer diagnosis.

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I have been treated with a complement inhibitor before.

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I am unwilling to get meningococcal and pneumococcal vaccines.

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My spleen is not working or has been removed.

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I have active or latent tuberculosis.

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I have a muscle condition or myositis that overlaps with another autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from screening visit through week 104

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met