NCT07064889

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

The Combination of Oral Upadacitinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of Upadacitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Detailed description

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of adults ITP patients in China. Patients were randomized to Upadacitinib + high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)
DRUG	Upadacitinib	Upadacitinib 15mg qd for 12 weeks

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-07-30
• Completion: 2027-12-30
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China