The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with a condition called immune thrombocytopenia (ITP), which causes low platelet counts and can lead to bleeding problems. The study is comparing the effects of a combination of two medicines—Upadacitinib and high-dose dexamethasone—against high-dose dexamethasone alone, which is a standard first treatment. The goal is to see if adding Upadacitinib helps improve platelet levels and overall safety for patients who are newly diagnosed with ITP.

Adults who have just been diagnosed with ITP and have very low platelet counts (below 30, or below 50 with significant bleeding symptoms) may be eligible to join. Participants must not have received any prior treatment for ITP and need to be willing to sign a consent form. People with certain infections, other serious health conditions, or who are pregnant or nursing cannot take part. If accepted, participants will receive either the combination treatment or just dexamethasone and will be closely monitored to understand how well the treatments work and how safe they are. This study is not yet recruiting, but it aims to help find better first treatment options for people with ITP.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmed newly-diagnosed, treatment-naive ITP;
• • 2. Platelet counts \<30×109/L ;
• • 3. Platelet counts \< 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
• • 4. Willing and able to sign written informed consent.
• Exclusion Criteria:
• • 1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
• • 2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
• • 3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
• • 4. Active infection;
• • 5. Maligancy;
• • 6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
• • 7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
• • 8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
• • 9. Patients who are deemed unsuitable for the study by the investigator.