Relapsing PolychondritisPhase 1/2NCT06873100
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
A Phase 1/2 study testing Upadacitinib and corticosteroids and immunosuppressants in people with Relapsing Polychondritis, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsing Polychondritis
- What is being tested?
- Upadacitinib and corticosteroids and immunosuppressants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jing He, MD and PhD, +8618611707347, hejing1105@gmail.com
About this study
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:
Read more
- 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
- Relapsing Polychondritis
- Being tested
- Upadacitinib, corticosteroids and immunosuppressants
- Keywords
- Relapsing polychondritis, Upadacitinib
- Medical subject headings
- Polychondritis, Relapsing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Upadacitinib is an oral Janus kinase (JAK) inhibitor used in this study to treat patients with relapsing polychondritis. The drug is administered at a dose of 15 mg once daily for a duration of 24 weeks.
corticosteroids and immunosuppressantsDrug
Corticosteroids combined with immunosuppressants is a conventional treatment for relapsing polychondritis. In this study, it serves as the control arm against Upadacitinib for the treatment of relapsing polychondritis. Dosing is tailored to the individual patient's condition, with the selection of different types of corticosteroids and immunosuppressive agents based on the specific needs of the patient's clinical profile.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: Upadacitinib |
| Countrol Group | Active comparator | Not described Receives: Drug: corticosteroids and immunosuppressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP variation
Modification of inflammatory makers
Measured: 24 weeks
Secondary outcomes (5)
Relapsing Polychondritis Disease Activity Index
Measured: 24 weeks
Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib
Cytokine and lymphocyte subgroups of T cell, B cell and NK cell are analyzed during the treatment.
Measured: 24 weeks
Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L)
The EQ-5D-5L is a health-related quality-of-life instrument developed by the EuroQol Group. It is designed to measure health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: 24 weeks
Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
We will investigate the potential pathways through which Upadacitinib exerts its effects and examine the changes in inflammatory biomarkers during the experimental process
Measured: 24 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events includes influenza-like symptoms, infection, fever, tumor,drug-induced liver and kidney damage.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Nov 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing PolychondritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
- Investigators
- Zhanguo Li, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873100
- Sponsor's protocol ID
- Upadacitinib RP
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
- ClinicalTrials.gov ID
- NCT06873100
- Acronym / sponsor ID
- Upadacitinib RP
- Conditions
- Relapsing Polychondritis
- Keywords
- Relapsing polychondritis, Upadacitinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Upadacitinib |
| Countrol Group | Active comparator | Drug: corticosteroids and immunosuppressants |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibUpadacitinib is an oral Janus kinase (JAK) inhibitor used in this study to treat patients with relapsing polychondritis. The drug is administered at a dose of 15 mg once daily for a duration of 24 weeks. | Drug | Experimental Group |
| corticosteroids and immunosuppressantsCorticosteroids combined with immunosuppressants is a conventional treatment for relapsing polychondritis. In this study, it serves as the control arm against Upadacitinib for the treatment of relapsing polychondritis. Dosing is tailored to the individual patient's condition, with the selection of different types of corticosteroids and immunosuppressive agents based on the specific needs of the patient's clinical profile. | Drug | Countrol Group |
Primary outcome
CRP variation
Time frame: 24 weeks
Modification of inflammatory makers
5 secondary outcomes
Relapsing Polychondritis Disease Activity Index
Time frame: 24 weeks
Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib
Time frame: 24 weeks
Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L)
Time frame: 24 weeks
Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib
Time frame: 24 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanguo Li principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Upadacitinib and corticosteroids and immunosuppressants in people with Relapsing Polychondritis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Wu (+8618766399762, 2411210283@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP variation (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.