Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06682169
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Rovadicitinib — DRUG
    Rovadicitinib is an inhibitor of Janus associated kinases (JAK) family and Rho associated kinases (ROCK). It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated kinase 2 (ROCK2). The JAK 1-JAK 2 signaling pathway is a key step in causing inflammation and tissue damage in acute and chronic graft-versus-host disease.
  • Imatinib — DRUG
    Imatinib tyrosine kinase inhibitor is a small molecule protein kinase inhibitor that has the ability to block one or more protein kinases. Clinically used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors.
  • Methotrexate — DRUG
    Methotrexate is an organic compound, mainly used as an anti folate anti-tumor drug. It inhibits the synthesis of tumor cells by inhibiting dihydrofolate reductase, thereby inhibiting the growth and reproduction of tumor cells.
  • Mycophenolate mofetil — DRUG
    Metoprolol ester is an organic compound mainly used as an immunosuppressant
  • Rituximab — DRUG
    Rituximab activates antibody dependent cell-mediated phagocytosis and complement dependent cytotoxicity by binding to cluster of differentiation 20 (CD20) antigen, clearing malignant B cells expressing CD20 and achieving therapeutic goals.

Study Details

The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.

Key Dates

Start date
Nov 20, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2029
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Rovadicitinib
    Rovadicitinib: 10mg, taken orally on an empty stomach twice a day, with a minimum interval of 8 hours between each dose, and an optimal interval of 12 hours. Every 28 days is a treatment cycle.
  • Active Comparator: Imatinib or Methotrexate or Mycophenolate or Rituximab
    Methotrexate tablets: 10mg, orally, once a week or 5mg, orally, twice a week. Metoprolol ester: 250mg-500mg, bid, orally. Imatinib: 100-400mg, qd, oral. Rituximab: 375mg/m2, administered intravenously once a week for 4 consecutive weeks.

Primary Outcome Measure

Objective remission rate in the 24th week (ORR) [ Time Frame: Week 24 ]

Central Contacts

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