Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Crohn's Disease AggravatedCrohn's Disease in Remission
Interventions
DRUG

Ustekinumab (approximately 6 mg/kg)

"At Week 0:~≤55 kg: 260 mg administered by intravenous (IV) infusion.~\>55 kg and ≤85 kg: 390 mg administered by intravenous (IV) infusion.~\>85 kg: 520 mg administered by intravenous (IV) infusion.~From Week 8 onward (i.e., at Week 8 and then every 8 weeks up to Week 52 or the end of the follow-up period):~90 mg administered by subcutaneous (SC) injection."

DRUG

Upadacitinib

"From Week 0 to Week 12: 45 mg once daily, administered orally.~From Week 13 through Week 52 or the end of the follow-up period: 30 mg once daily, administered orally."

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER