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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 of birth control with her sexual partner during the study and for 120 days after study completion.

• 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.

Locations
United States
Texas
Austin Neuromuscular Center
RECRUITING
Austin
Austin Neuromuscular Center
RECRUITING
Austin
Contact Information
Primary
Yessar Hussain, MD
yessar@austinneuromuscle.com
5129200140
Backup
Emil Hussain, Manager
emil@austinneuromuscle.com
5129200140
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2027-08-30
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Austin Neuromuscular Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.