Adults 18 to 75, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12Primary· Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of na
Group
Value
95% CI
BI 706321 and Ustekinumab
-1.69
-3.75 – 0.37
Placebo and Ustekinumab
-3.62
-5.63 – -1.60
Percent Change in SES-CD From Baseline at Week 12Secondary· Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percent change in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of nar
Group
Value
95% CI
BI 706321 and Ustekinumab
-14.18
-30.30 – 1.95
Placebo and Ustekinumab
-27.52
-43.30 – -11.73
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 12Secondary· Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percentage of patients with endoscopic response (defined as \>50% Simple Endoscopic Score for Crohn's disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is o
Group
Value
95% CI
BI 706321 and Ustekinumab
12.5
4.3 – 31.0
Placebo and Ustekinumab
40.0
23.4 – 59.3
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 48Secondary· Within 28 days before randomization (baseline) and 48 weeks after first drug administration.
Percentage of patients with endoscopic response (defined as \>50% Simple Endoscopic Score for Crohn's disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is o
Group
Value
95% CI
BI 706321 and Ustekinumab
16.7
6.7 – 35.9
Placebo and Ustekinumab
16.0
6.4 – 34.7
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 12Secondary· 12 weeks after first drug administration.
Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease (SES-CD) score of ≤2) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56,
Group
Value
95% CI
BI 706321 and Ustekinumab
4.2
0.7 – 20.2
Placebo and Ustekinumab
8.0
2.2 – 25.0
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 48Secondary· 48 weeks after first drug administration.
Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease (SES-CD) score of ≤2) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56,
Group
Value
95% CI
BI 706321 and Ustekinumab
8.3
2.3 – 25.8
Placebo and Ustekinumab
8.0
2.2 – 25.0
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 12Secondary· 12 weeks after first drug administration.
Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \< 5 mg/L and faecal calprotectin (FCP) \< 250 ug/g at Week 12 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.
Group
Value
95% CI
BI 706321 and Ustekinumab
16.7
6.7 – 35.9
Placebo and Ustekinumab
20.0
8.9 – 39.1
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 48Secondary· 48 weeks after first drug administration.
Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) \< 5 mg/L and faecal calprotectin (FCP) \< 250 ug/g at Week 48 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.
Group
Value
95% CI
BI 706321 and Ustekinumab
12.5
4.3 – 31.0
Placebo and Ustekinumab
16.0
6.4 – 34.7
Percentage of Patients With Clinical Remission at Week 12, Defined as a Crohn's Disease Activity Index (CDAI) Score of <150Secondary· Data was collected for 7 days prior to 12 weeks after first drug administration.
Percentage of patients with clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of \<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for s
Group
Value
95% CI
BI 706321 and Ustekinumab
37.5
21.2 – 57.3
Placebo and Ustekinumab
56.0
37.1 – 73.3
Percentage of Patients With Clinical Remission at Week 48, Defined as a CDAI Score of <150Secondary· Data was collected for 7 days prior to 48 weeks after first drug administration.
Percentage of patients with clinical remission at Week 48, defined as a CDAI score of \<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the
Group
Value
95% CI
BI 706321 and Ustekinumab
20.8
9.2 – 40.5
Placebo and Ustekinumab
20.0
8.9 – 39.1
Percentage of Patients With Clinical Response at Week 12, Defined by a CDAI Reduction From Baseline of at Least 100 Points, or a CDAI Score of <150Secondary· Within 28 days before randomization (baseline) and for 7 days prior to 12 weeks after first drug administration.
Percentage of patients with clinical response at Week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of \<150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide co
Group
Value
95% CI
BI 706321 and Ustekinumab
45.8
27.9 – 64.9
Placebo and Ustekinumab
68.0
48.4 – 82.8
Number of Patients With Treatment-emergent Adverse Event (TEAE) Through End of Treatment (EoT) and the REP PeriodSecondary· From first drug administration until 16 days after last drug administration, up to 27 weeks.
Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period is reported.
Group
Value
95% CI
BI 706321 and Ustekinumab
11
Placebo and Ustekinumab
12
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration, until end of follow-up period, up to 48 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05183360 — A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated
· Phase 1
· terminated
NCT04714073 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood
· Phase 1
· completed
NCT03971695 — A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
· Phase 1
· completed
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
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· Phase 2
· recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
· Phase 4
· recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
· recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease
· EARLY_PHASE1
· recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
· Phase 2, PHASE3
· recruiting
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Trials by the same sponsor.
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· not yet recruiting
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NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 4 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04978493.