Clinical trial NCT06873100: Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Official title: Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsing Polychondritis
Keywords: Relapsing polychondritis
Upadacitinib
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: CRP variation
timeFrame: 24 weeks
Secondary outcomes:
measure: Relapsing Polychondritis Disease Activity Index
timeFrame: 24 weeks
measure: Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib
timeFrame: 24 weeks
measure: Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 24 weeks
measure: Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
timeFrame: 24 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rheumatology and Immunology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University Institute of Rheuamotology and Immunology
name: Zhanguo Li
role: PRINCIPAL_INVESTIGATOR
References: