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NCT Number: NCT06682169

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

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 6 months;
  • Previously received allogeneic hematopoietic stem cell transplantation;
  • According to NIH standards, the clinical diagnosis is moderate to severe cGVHD；
  • Previously received systematic treatment for cGVHD with 2-5 lines;
  • Stable dosage of corticosteroids and other immunosuppressants received within 2 weeks prior to screening;
  • The main organ functions well;
  • Starting from Day 1 after enrollment in the control group of this study, participants must receive one of the drugs specified in the study protocol;
  • Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study; Serum pregnancy test negative within 7 days prior to enrollment in the study, and must be a non lactating subject; Male participants should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
  • Subjects voluntarily joined this study, signed informed consent, and had good compliance.

Exclusion criteria

  • Has experienced or currently suffers from other malignant tumors within the past 3 years;
  • Known or suspected active aGVHD；
  • Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;
  • The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;
  • Random failure of allogeneic hematopoietic stem cell transplantation within the first 6 months or having received 2 allogeneic hematopoietic stem cell transplants in the past;
  • Used JAK inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, etc. within the first 2 weeks of randomization;
  • There are multiple factors that can affect oral medication, such as inability to swallow, intestinal obstruction, etc;
  • Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
  • Subjects with any severe and/or uncontrolled illnesses;
  • Individuals who are allergic to research drugs or their components;
  • Participated in other clinical trials within the first 4 weeks of randomization;
  • According to the researcher's judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are deemed unsuitable for inclusion due to other reasons.

Treatment and study plan

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.

Primary outcomes

  1. Objective remission rate in the 24th week (ORR)

    Time frame: Week 24

    Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined.

Secondary outcomes

  1. Best Objective Response Rate (BOR)

    Time frame: Week 24

    The best therapeutic effect among all therapeutic outcomes

  2. Duration of Relief (DOR)

    Time frame: Through study completion, an average of 2 year

    The duration of symptom relief for patients after receiving treatment

  3. Improvement in Lee cGVHD symptom score of subjects in week 24

    Time frame: Week 24

    The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms.

  4. Failure free survival (FFS)

    Time frame: Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96

    The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient

  5. Primary disease recurrence rate (MR)

    Time frame: Weeks 8, 16,24， 36, 48

    The probability of recurrence of the patient's disease within a certain period of time.

  6. Non-Relapse Mortality (NRM)

    Time frame: Weeks 8, 16,24， 36, 48

    NRM was defined as death without recurrent or progressive disease

  7. Overall survival (OS)

    Time frame: Through study completion, an average of 2 year

    From randomization to the time of death caused by any reason

  8. Percentage of subjects whose daily glucocorticoid dose decreased

    Time frame: Week 24

    Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids

  9. Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)

    Time frame: Through study completion, an average of 2 year

    The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√"

  10. Changes in 5-level EQ-5D (EQ-5D-5L)

    Time frame: Through study completion, an average of 2 year

    The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty)

  11. Adverse events (AE)

    Time frame: Through study completion, an average of 2 year

    The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.

  12. Cmax

    Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)

    The maximum concentration of medication that enters the bloodstream after administration

  13. Ctrough

    Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)

    After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration

Study contacts

Contact information is provided by the study sponsor or research team.

He Huang, Doctor

CONTACT

[email protected]

13605714822

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open Label, Positive Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of the Selected Regimen of Rovadicitinib in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 12, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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