RECRUITING

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

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Conditions

Sporadic Inclusion Body Myositis (sIBM)Idiopathic Inflammatory Myopathies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-08
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06479863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. 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.
  3. 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:
  4. * Intravaginal
  5. * Transdermal
  6. * Progestogen-only hormonal contraception associated with inhibition of ovulation:
  7. * Oral
  8. * Injectable
  9. * Implantable
  10. * Vasectomized partner
  11. * 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 with her sexual partner during the study and for 120 days after study completion.
  12. 8. If male, the subject must have had a vasectomy or must use a reliable method of birth control with their partner or maintain total abstinence from sexual intercourse. The subject must agree to continue using his selected method of birth control with his sexual partner during the study and for 120 days after the study completion.
  1. * 1. Other neurological conditions (e.g., hemiplegia post-stroke, Parkinson's Disease) or musculoskeletal conditions (e.g., severe osteoarthritis) causing mobility impairment.
  2. 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.
  3. 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 administered during the screening period and prior to initiation of study treatment.
  4. 7. Known contraindication to meningococcal (group ACWY conjugate and group B vaccines) and pneumococcal vaccines.
  5. 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 syndrome).
  6. 10. Active or recent systemic infection within 2 weeks prior to Baseline. 11. Pregnant, planning to become pregnant, or lactating female subjects. 12. Treatment with an experimental drug within 30 days or 5 half-lives of the experimental drug.
  7. 13. Participation in another concurrent interventional clinical trial. 14. Subjects with functional and anatomic asplenia 15. Subjects with positive tests for hepatitis B, hepatitis C, or HIV at screening 16. Presence of active or latent tuberculosis 17. Presence of any other form of myositis or myopathy or myositis overlap with other autoimmune diseases 18. Presence of other autoimmune or autoinflammatory diseases

Contacts and Locations

Study Contact

Yessar Hussain, MD
CONTACT
5129200140
yessar@austinneuromuscle.com
Emil Hussain, Manager
CONTACT
5129200140
emil@austinneuromuscle.com

Principal Investigator

Yessar Hussain, MD
PRINCIPAL_INVESTIGATOR
Austin Neuromuscular Center

Study Locations (Sites)

Austin Neuromuscular Center
Austin, Texas, 78759
United States
Austin Neuromuscular Center
Austin, Texas, 78759
United States

Collaborators and Investigators

Sponsor: Austin Neuromuscular Center

  • Yessar Hussain, MD, PRINCIPAL_INVESTIGATOR, Austin Neuromuscular Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2024-08-08
Study Completion Date2027-08-30

Terms related to this study

Additional Relevant MeSH Terms

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