Evaluating Upadacitinib for treating relapsing polychondritis
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
This study is testing if a new medication called Upadacitinib can help adults with relapsing polychondritis feel better compared to standard treatments like steroids and immunosuppressants.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | rituximab, methotrexate, cyclophosphamide, Upadacitinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06873100 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of Upadacitinib in adults with relapsing polychondritis, a rare autoimmune disorder. Participants will receive either Upadacitinib or conventional therapies, including corticosteroids and immunosuppressants, for 24 weeks. The study will monitor disease activity and any medical issues arising from the treatment through monthly hospital visits. The goal is to determine if Upadacitinib can effectively reduce disease activity compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have not responded adequately to standard treatments for at least four weeks.
Not a fit: Patients currently using rituximab or other monoclonal antibodies, or those with serious complications such as heart failure or renal insufficiency, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from relapsing polychondritis.
How similar studies have performed: While there is limited data on Upadacitinib specifically for relapsing polychondritis, similar studies with targeted therapies in autoimmune conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Male or female ≥18 and ≤70 years * 2.Meet the revised Michet criteria * 3.Patients had an inadequate response to standard treatment for ≥ 4 weeks. The background treatment included corticosteroids (≤0.5 mg/ kg), immunosuppressants ( methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil leflunomide, or cyclophosphamide) * 4\. Negative urine pregnancy test * 5\. Written informed consent form Exclusion Criteria: Any subject who meets any of the following criteria shall be excluded: * 1.Use rituximab or other monoclonal antibodies within 2 months. * 2.1 months after treatment with high dose glucocorticoid (\> 1 mg/kg/d). * 3.Serious complications: heart failure (≥ New York Heart Association（NYHA） III grade), renal insufficiency (creatinine clearance rate ≤ 30 ml/min), liver function insufficiency (serum alanine transaminase or glutamic-pyruvic transaminaseT \> 3 times normal upper limit, or total bilirubin \> normal upper limit) * 4.Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve, or brain diseases (including demyelination diseases, such as multiple sclerosis). * 5.Known allergies, hyperresponsiveness or IL-2 or its excipients are intolerant. * 6.Severe infections (including, but not limited to, hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), hospitalization for infection, or intravenous antibiotics 2 months before the first dose of treatment. * 7.Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months before the first use of the study. * 8.Infected with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, consult a doctor with expertise in the treatment of HIV or hepatitis C virus infection. * 9.There has been any known malignant tumor or history of malignant tumor in the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no sign of recurrence or surgically cured cervical tumor within 3 months of use of the first study preparation). * 10.There are uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past three years, which may hinder the successful completion of the study. 11.Within 3 months before the first injection of the research agent, during the study period or within 4 months after the last injection of the research agent, any live virus or bacterial vaccine is received or expected to be received. Bacillus Calmette-Guerin was vaccinated within 12 months after screening. * 11.Pregnant and lactating women (WCBP) are reluctant to use medically approved contraceptives during and 12 months after treatment. * 12.Men whose partners have fertility potential but do not want to use appropriate medically approved contraceptives during and within 12 months of treatment.
Where this trial is running
Beijing, Beijing Municipality
- Department of Rheumatology and Immunology, Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhanguo Li — Peking University Institute of Rheuamotology and Immunology
- Study coordinator: Yifan Wu
- Email: 2411210283@stu.pku.edu.cn
- Phone: +8618766399762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.