Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Upadacitinib
  • corticosteroids and immunosuppressants

Treatment groups

30 Participants
are divided into 2 treatment groups