Subcutaneous Semaglutide in Systemic Scleroderma

NCT06149260 | Recruiting Phase 1 DMC

• 1 other identifier: LYG2022061
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

Conditions

Scleroderma, Systemic; Fibrosis; Semaglutide

Outcome Measures

Primary Outcomes (1)

• Change in modified Rodnan skin score (mRSS) at week 24

  Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)

  Baseline and 24 weeks

Secondary Outcomes (10)

• Incidence of Adverse Events

  Baseline and 24 weeks

• Incidence of Severe Adverse Events

  Baseline and 24 weeks

• the scleroderma health assessment questionnaire-disability index (sHAQ-DI)

  Baseline and 24 weeks

• High-resolution computer tomography (HRCT)

  Baseline and 24 weeks

• Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)

  Baseline and 24 weeks

Study Arms (1)

Semaglutide

EXPERIMENTAL

Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week.

Drug: Semaglutide Pen Injector

Interventions

Semaglutide Pen Injector DRUG

Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.

Semaglutide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

the Second Xiangya Hospital

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Fibrosis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rong Xiao, MD

  Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, China

  STUDY CHAIR

• Licong Liu, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Yaqian Shi, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Zhuotong Zeng, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Zhan Yi, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Xiangning Qiu, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Ruixuan Zhu, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Yi Wei, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Ke Chai, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Hao Ren, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• Yangfan Xiao, MD

  Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Xiao, MD

CONTACT

13808425555; xiaorong65@csu.edu.cn

Licong Liu, MD

CONTACT

18573185298; Liulicong1997@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, MD

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 28, 2023
• Study Start: February 29, 2024
• Primary Completion: August 29, 2024
• Study Completion: December 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)