Status:
RECRUITING
Subcutaneous Semaglutide in Systemic Scleroderma
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Scleroderma, Systemic
Fibrosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Detailed Description
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, in...
Eligibility Criteria
Inclusion
- (Those who have not achieved good results after hormone or immunosuppressive therapy)
- Gender unlimited;
- Age 18-65 years old (including 65 years old);
- Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.
- Has received one or more of the following standard systemic treatments allowed by the research protocol:
- Before the first subcutaneous injection of the study, oral corticosteroids (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks, and stabilizers were administered for ≥ 4 weeks.
- Before the first subcutaneous injection of the study, patients were treated with Tofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6 weeks.
- If one or more of the following immune modulators are used, treatment must be given for ≥ 12 weeks before the start of the study, and treatment with a stabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acid Cyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs in combination, the appropriateness of the subjects' participation in the study must be discussed with the medical supervisor and study chair before enrollment.
- A modified Rodnan Skin Score (mRSS) of \> 14
- Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.
Exclusion
- Prior to the first dose, Body Mass Index (BMI) \< 18.5 kg/m2; weight loss of 10% within one month or 20% within six months.
- Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives.
- History of malignant tumors or a history of malignant tumors within the past 5 years before screening.
- Presence of other inflammatory diseases that may interfere with efficacy assessment, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease.
- Severe gastrointestinal complications of systemic sclerosis (SSc), such as significant swallowing difficulties, and severe diseases affecting vital organ systems such as the heart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participation in the study by the investigator.
- Known current active or recurrent severe infections, including active tuberculosis.
- Congenital immunodeficiency or congenital immunosuppression.
- Substance abuse, alcoholism, or psychiatric disorders, rendering patients uncooperative or unable to adhere to treatment; poor predictability of compliance.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Patients currently participating in other clinical trials.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06149260
Start Date
February 29 2024
End Date
December 1 2024
Last Update
March 5 2024
Active Locations (1)
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1
the Second Xiangya Hospital
Changsha, Hunan, China, 410011