Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

NCT06873100 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Upadacitinib RP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Polychondritis

Keywords

Relapsing polychondritis; Upadacitinib

Outcome Measures

Primary Outcomes (1)

• CRP variation

  Modification of inflammatory makers

  24 weeks

Secondary Outcomes (5)

• Relapsing Polychondritis Disease Activity Index

  24 weeks

• Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib

  24 weeks

• Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L)

  24 weeks

• Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib

  24 weeks

• Incidence of Treatment-Emergent Adverse Events

  24 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Upadacitinib

Countrol Group

ACTIVE COMPARATOR

Drug: corticosteroids and immunosuppressants

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.

Experimental Group

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.

Countrol Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any subject who meets any of the following criteria shall be excluded:
• Use rituximab or other monoclonal antibodies within 2 months.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Polychondritis, Relapsing

Interventions

upadacitinib; Adrenal Cortex Hormones; Immunosuppressive Agents

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zhanguo Li

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Wu

CONTACT

+8618766399762; 2411210283@stu.pku.edu.cn

Jing He

CONTACT

+8618611707347; hejing1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 12, 2025
• Study Start: November 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-10

Locations

CN (1)