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Tests treatment safety and results for Sporadic Inclusion Body Myositis (sIBM)
Official title Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
ClinicalTrials.gov ID: NCT06479863
What this study is testing
What is Pozelimab/Cemdisiran?
Pozelimab/Cemdisiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sporadic inclusion body myositis (sibm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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...
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
You likely can't join if
- 1\. Other neurological conditions (e.g., hemiplegia post-stroke, Parkinson's Disease) or musculoskeletal conditions (e.g., severe osteoarthritis)...
- 2\. Any known active malignancy 3. Significant illness or history of significant illness that, in the investigator's opinion, may adversely affect...
- 4\. Any previous treatment with a complement inhibitor 5. History of meningococcal disease 6. No documented meningococcal and pneumococcal...
- 7\. Known contraindication to meningococcal (group ACWY conjugate and group B vaccines) and pneumococcal vaccines.
- 8\. Subject unwilling to receive meningococcal and pneumococcal vaccinations. 9. Patients with screening serum ALT levels \>3×ULN and/or total...
- 10\. Active or recent systemic infection within 2 weeks prior to Baseline. 11. Pregnant, planning to become pregnant, or lactating female people. 12...
See the full eligibility 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...
- 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 of birth control...
- 1\. Other neurological conditions (e.g., hemiplegia post-stroke, Parkinson's Disease) or musculoskeletal conditions (e.g., severe osteoarthritis) causing mobility impairment.
- 2\. Any known active malignancy 3. Significant illness or history of significant illness that, in the investigator's opinion, may adversely affect the patient's participation in this study.
- 4\. Any previous treatment with a complement inhibitor 5. History of meningococcal disease 6. No documented meningococcal and pneumococcal vaccination within 5 years prior to screening visit unless vaccination will be...
- 7\. Known contraindication to meningococcal (group ACWY conjugate and group B vaccines) and pneumococcal vaccines.
- 8\. Subject unwilling to receive meningococcal and pneumococcal vaccinations. 9. Patients with screening serum ALT levels \>3×ULN and/or total bilirubin \>2×ULN (unless bilirubin elevation is due to suspected Gilbert's...
- 10\. Active or recent systemic infection within 2 weeks prior to Baseline. 11. Pregnant, planning to become pregnant, or lactating female people. 12. Treatment with an experimental drug within 30 days or 5 half-lives of...
- 13\. Participation in another concurrent treatment clinical trial. 14. people with functional and anatomic asplenia 15. people with positive tests for hepatitis B, hepatitis C, or HIV at screening 16. Presence of active...
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.