Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Sponsor
Peking University People's Hospital
Study ID
NCT06873100
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Relapsing Polychondritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    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 immunosuppressants — DRUG
    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 Details

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.

Key Dates

Start date
Nov 15, 2024
Status verified
Oct 2024
Primary completion
Aug 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
  • Active Comparator: Countrol Group

Primary Outcome Measure

CRP variation [ Time Frame: 24 weeks ]

Central Contacts

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