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Comparing Rovadicitinib to Other Treatments for Chronic Graft-versus-host Disease

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

Phase 3 Interventional Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT06682169

This study is testing if Rovadicitinib can help people with moderate to severe chronic graft-versus-host disease who haven't found relief from other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored
Locations41 sites (Hefei, Anhui and 40 other locations)
Trial IDNCT06682169 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Rovadicitinib in patients with moderate to severe chronic graft-versus-host disease (cGVHD) who have already undergone multiple lines of treatment. Participants will be compared to a control group receiving a treatment protocol selected by researchers. The primary outcome is to assess the objective response rate at week 24. Eligible patients must have received allogeneic hematopoietic stem cell transplantation and have stable organ function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with moderate to severe cGVHD who have undergone multiple lines of treatment.

Not a fit: Patients who have not received allogeneic hematopoietic stem cell transplantation or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic graft-versus-host disease.

How similar studies have performed: Other studies have explored treatments for cGVHD, but the specific use of Rovadicitinib in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hefei, Anhui and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Graft-versus-host Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.