Actively Recruiting
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Led by Peking University People's Hospital · Updated on 2025-03-12
30
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures. The goal of this clinical trial is to learn if drug Upadacitinib works to treat relapsing polychondritis in adults. It will also learn about the safety of drug Upadacitinib. The main questions it aims to answer are: * Does drug Upadacitinib reduce the disease activity of relapsing polychondritis? * What medical problems do participants have when taking drug Upadacitinib? Researchers will compare drug Upadacitinib to conventional therapies (treatment with corticosteroids combined with immunosuppressants) to see if drug Upadacitinib works to treat relapsing polychondritis. Participants will: * Take drug Upadacitinib or corticosteroids combined with immunosuppressants every day for 24 weeks. * Visit the hospital once every month for checkups and tests. This clinical study will explore the efficacy and immunological evaluation of Upadacitinib in the treatment of RP.
CONDITIONS
Official Title
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Meet the revised Michet criteria for relapsing polychondritis
- Inadequate response to standard treatment for at least 4 weeks with corticosteroids (up to 0.5 mg/kg) and immunosuppressants
- Negative urine pregnancy test
- Signed written informed consent form
You will not qualify if you...
- Use of rituximab or other monoclonal antibodies within 2 months
- Treatment with high-dose glucocorticoids (>1 mg/kg/day) within 1 month
- Serious heart failure (NYHA class III or higher), kidney insufficiency (creatinine clearance ≤30 ml/min), or liver dysfunction (ALT or AST >3 times upper limit or elevated bilirubin)
- Other serious, progressive, or uncontrolled diseases affecting blood, gastrointestinal, endocrine, lung, heart, nerve, or brain, including demyelinating diseases
- Known allergies or intolerance to IL-2 or its components
- Severe infections or hospitalization for infection, or intravenous antibiotics within 2 months before treatment
- Abnormal chest imaging showing tumors or active infections within 3 months before treatment
- HIV or hepatitis C infection
- History of malignant tumors within past 5 years except certain skin cancers or surgically cured cervical tumor
- Uncontrolled mental or emotional disorders or recent drug/alcohol abuse
- Receipt or expected receipt of live virus or bacterial vaccines within 3 months before, during, or 4 months after treatment
- Pregnant or breastfeeding women unwilling to use approved contraception during and 12 months after treatment
- Men with partners who have fertility potential and who are unwilling to use approved contraception during and 12 months after treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yifan Wu
CONTACT
J
Jing He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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