NCT04978493

A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease

A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease. Participants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab. Participants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months. Participants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	BI 706321	One dose of 8 mg as tablets orally once per day in the morning
DRUG	Ustekinumab	A single intravenous infusion of 260 mg (body weight ≤55 kg), 390 mg (body weight 55-85 kg), or 520 mg (body weight \>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg every 8 weeks.
DRUG	Placebo	One dose of placebo matching BI 706321 as tablets orally once per day in the morning

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-07-08
• Completion: 2024-08-08
• First posted: 2021-07-27
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

49 sites across 11 countries: United States, Belgium, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study