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

Sponsor
Peking University People's Hospital
Study ID
NCT07064889
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    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)
  • Upadacitinib — DRUG
    Upadacitinib 15mg qd for 12 weeks

Study Details

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).

Key Dates

Start date
Jul 30, 2025
Status verified
Jul 2025
Primary completion
Jul 30, 2027
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: Upadacitinib and HD-DXM
    Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10) and Upadacitinib 15mg qd po, 12 consecutive weeks
  • Active Comparator: HD-DXM
    Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

Primary Outcome Measure

Sustained response [ Time Frame: 6 month ]

Central Contacts

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