Clinical Trials Logo
  1. Home
  2. Crohn Disease
  3. NCT04978493

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

Crohn Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04978493
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 4, 2021
Completion date March 1, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Recruiting NCT05169593 - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy Phase 4
Recruiting NCT06116604 - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT05294107 - Intestinal Organoids N/A
Recruiting NCT05627128 - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease N/A
Withdrawn NCT04349449 - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT03058679 - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease N/A
Completed NCT02871635 - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity Phase 3
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Recruiting NCT03913572 - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Terminated NCT04102111 - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease Phase 2
Recruiting NCT04997733 - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal Phase 3
Recruiting NCT05906576 - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients Phase 4
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04502303 - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease Phase 2