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

Conditions

• Crohn Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• BI 706321 — DRUG
  One dose of 8 mg as tablets orally once per day in the morning
• Ustekinumab — DRUG
  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.
• Placebo — DRUG
  One dose of placebo matching BI 706321 as tablets orally once per day in the morning

Study Details

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.

Key Dates

Start date

Dec 2, 2021

Status verified

Aug 2025

Primary completion

Jul 8, 2024

Completion

Aug 8, 2024

Study Design

Enrollment

49 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BI 706321 and ustekinumab
  Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks. A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \[kg\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.
• Placebo Comparator: Placebo and ustekinumab
  Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks. A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram \[kg\]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight \>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks.

Primary Outcome Measure

Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 [ Time Frame: Within 28 days before randomization (baseline) and 12 weeks after first drug administration. ]

Locations (15)

Find similar trials in Northridge, CA

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