Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inc… (NCT06479863) | Clinical Trial Compass
RecruitingEarly Phase 1
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
United States10 participantsStarted 2024-08-08
Plain-language summary
To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM
Who can participate
Age range45 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
7\. If female, the subject must be: (a) surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. or (b) of childbearing potential and using a birth control method, such as:
•Combined (estrogen and progestogen-containing) hormonal. contraception associated with inhibition of ovulation:
o Oral
* Intravaginal
* Transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation:
* Oral
* Injectable
* Implantable
• Intrauterine device
• Intrauterine hormone-releasing system
• Bilateral tubal occlusion
* Vasectomized partner
* Sexual abstinence or of non-childbearing potential (i.e., no menses for ≥12 consecutive months without any other underlying medical cause) The subject must agree to continue using her selected method o…
What they're measuring
1
IBM-Functional Rating Scale (IBM-FRS)
Timeframe: change from screening visit through week 104.
2
IBM Physical Functioning Assessment (sIFA)
Timeframe: change from screening visit through week 104.