Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

PHASE4RecruitingINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

July 15, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

July 31, 2027

Conditions
Crohn Disease
Interventions
DRUG

Ustekinumab and Upadacitinib

Participants in this group will maintain the original Ustekinumab regimen, receiving 90 mg administered subcutaneously every 8 weeks. In addition, they will receive Upadacitinib administered orally at a dosage of 45 mg daily for 12 weeks. After the 12-week period, the dosage of Upadacitinib will be adjusted based on patient condition and clinical judgment, continuing until the evaluation at week 16. Clinical efficacy of the dual-target therapy will be evaluated at week 16.

DRUG

Ustekinumab

Participants will receive an additional induction dose of Ustekinumab administered intravenously at 6 mg/kg at baseline. This will be followed by subcutaneous maintenance therapy of 90 mg every 4 weeks. Clinical efficacy will be evaluated at week 16.

Trial Locations (1)

510000

RECRUITING

Wei Wang, Guangzhou

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER