NCT07510191: CD

TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response

Recruiting now Phase 4 Last updated 3 April 2026

What this trial tests

Phase 4 trial testing Upadacitinib in Crohn Disease (CD) in 312 participants. Currently enrolling.

Timeline

1 March 2026

Primary endpoint
31 December 2028

31 December 2029

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	312
Start date	1 March 2026
Primary completion	31 December 2028
Estimated completion	31 December 2029
Sites	1 location across China

Drugs / interventions tested

• Upadacitinib — full drug profile →
• Infliximab Dose Intensification
• Adalimumab Dose Intensification
• Standard-Dose infliximab
• Standard-Dose Adalimumab

Conditions studied

• Crohn Disease (CD) — all drugs for Crohn Disease (CD) →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 18 to 65, any sex, with Crohn Disease (CD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score \<150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.