Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis

Part of paid clinical trials in Austin, Texas.

Sponsor
Austin Neuromuscular Center
Study ID
NCT06479863
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Inflammatory Myopathies
  • Sporadic Inclusion Body Myositis (sIBM)

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pozelimab/Cemdisiran — COMBINATION_PRODUCT
    Patients to receive Pozelimab 200mg/Cemdisiran 200 mg SC injections every 4 weeks for 104 weeks

Study Details

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

Key Dates

Start date
Aug 8, 2024
Status verified
Jan 2026
Primary completion
May 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: INJECTION
    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.

Primary Outcome Measure

IBM-Functional Rating Scale (IBM-FRS) [ Time Frame: change from screening visit through week 104. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Austin Neuromuscular CenterAustinTexas78759
Emil Hussain, Manager
[email protected]
5129200140
Marisol Barrientos, Superviser
[email protected]
5129200140
Austin Neuromuscular CenterAustinTexas78759
Emil Hussain
[email protected]
5129200140
Yessar hussain, MD (PRINCIPAL_INVESTIGATOR)

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Austin Neuromuscular Center· Austin, TX

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