Actively Recruiting
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
Led by Austin Neuromuscular Center · Updated on 2026-01-16
10
Participants Needed
2
Research Sites
159 weeks
Total Duration
On this page
Sponsors
A
Austin Neuromuscular Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM
CONDITIONS
Official Title
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 to 75 years
- Diagnosed with sporadic Inclusion Body Myositis based on the ENMC IBM Research Diagnostic Criteria
- Willing and able to comply with clinic visits and study procedures
- Provide informed consent signed by the patient or legally acceptable representative
- Able to understand and complete study questionnaires
- Able to walk at least 20 feet with or without an assistive device without support from another person or furniture
- If female, surgically sterilized or using an approved birth control method and agree to continue during and 120 days after the study
- If male, vasectomized or using reliable birth control or abstaining and agree to continue during and 120 days after the study
You will not qualify if you...
- Other neurological or musculoskeletal conditions causing mobility impairment
- Any known active cancer
- Significant illness that may affect study participation
- Previous treatment with a complement inhibitor
- History of meningococcal disease
- No meningococcal and pneumococcal vaccination within 5 years unless administered during screening
- Known contraindication to meningococcal and pneumococcal vaccines
- Unwillingness to receive meningococcal and pneumococcal vaccinations
- Screening serum ALT levels >3 times upper limit or total bilirubin >2 times upper limit (unless Gilbert's syndrome)
- Active or recent systemic infection within 2 weeks before baseline
- Pregnant, planning pregnancy, or breastfeeding
- Treatment with an experimental drug within 30 days or 5 half-lives
- Participation in another interventional clinical trial
- Functional or anatomic asplenia
- Positive tests for hepatitis B, hepatitis C, or HIV at screening
- Active or latent tuberculosis
- Other forms of myositis or myopathy or overlap with autoimmune diseases
- Other autoimmune or autoinflammatory diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Austin Neuromuscular Center
Austin, Texas, United States, 78759
Actively Recruiting
2
Austin Neuromuscular Center
Austin, Texas, United States, 78759
Actively Recruiting
Research Team
Y
Yessar Hussain, MD
CONTACT
E
Emil Hussain, Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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