ClinicalTrials.gov record NCT06873100

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 70 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized phase 1/2 trial compares oral upadacitinib with conventional treatment (corticosteroids plus immunosuppressants) in adults with relapsing polychondritis. Participants take the assigned medication daily for 24 weeks and attend monthly clinic visits for checkups and tests. The study measures inflammation, disease activity, immune-system changes and adverse events.

What it is studying. Whether daily upadacitinib for 24 weeks affects inflammation and disease activity in adults with relapsing polychondritis, and what safety and immunological changes occur compared with corticosteroids plus immunosuppressants.

What the researchers hope to learn. To evaluate changes in inflammatory markers (including CRP), relapsing polychondritis disease activity, immune cell subgroups and cytokines, quality-of-life scores (EQ-5D-5L), and the incidence of treatment-emergent adverse events over 24 weeks.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Upadacitinib
  • corticosteroids and immunosuppressants

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male or female ≥18 and ≤70 years
  • Meet the revised Michet criteria
  • 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)
  • Negative urine pregnancy test
  • Written informed consent form

Exclusion criteria

  • Any subject who meets any of the following criteria shall be excluded:
  • Use rituximab or other monoclonal antibodies within 2 months.
  • 1 months after treatment with high dose glucocorticoid (> 1 mg/kg/d).
  • 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)
  • Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve, or brain diseases (including demyelination diseases, such as multiple sclerosis).
  • Known allergies, hyperresponsiveness or IL-2 or its excipients are intolerant.
  • 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.
  • Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months before the first use of the study.
  • 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.
  • 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).
  • 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.
  • Pregnant and lactating women (WCBP) are reluctant to use medically approved contraceptives during and 12 months after treatment.
  • Men whose partners have fertility potential but do not want to use appropriate medically approved contraceptives during and within 12 months of treatment.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be randomly assigned to take oral upadacitinib 15 mg once daily or conventional therapy (corticosteroids plus an immunosuppressant) for 24 weeks. They will visit the study site about once a month for checkups and tests, which include blood and immunological analyses (lymphocyte subpopulations and cytokines), measurements of inflammation (CRP), disease-activity assessments (Relapsing Polychondritis Disease Activity Index), and quality-of-life questionnaires (EQ-5D-5L). Safety monitoring (including liver and kidney tests and tracking of adverse events) will occur during the study; a urine pregnancy test is required at screening and contraception is required per the protocol. Live vaccines are restricted during the time periods specified in the eligibility rules.

How the study is structured. Interventional, randomized, open-label (no masking), parallel two-arm study in phase 1/2. One arm receives upadacitinib 15 mg orally once daily for 24 weeks; the other receives corticosteroids combined with immunosuppressants tailored to the patient. Participants have monthly clinic visits and measurements over the 24-week treatment period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on relapsing polychondritis

Clinical trials4 trials listed for relapsing polychondritisEvery trial the registry lists for relapsing polychondritis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in relapsing polychondritis researchLatest monthly update: September 2026. Includes: CT airway findings. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 15, 2024
Primary completion
Aug 1, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Mar 12, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking University People's Hospital
Principal investigator
He Jing, Professor
Peking University People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Department of Rheumatology and Immunology, Peking University People's HospitalRecruiting

    Beijing, Beijing Municipality, 100044 · China

Terms used on this page · explanations by MedicalUpdates.ai

corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
hydroxychloroquine
A medicine used for some autoimmune conditions. It appears in eligibility criteria when a study requires or excludes its use.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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