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Spesolimab for Intestinal stricture

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial tests whether adding a drug called spesolimab to standard treatment can help adults aged 18-75 with worsening bowel narrowings due to Crohn's disease. Spesolimab aims to reduce inflammation and improve bowel condition. Participants will be monitored over more than a year to compare the effects of spesolimab.

Eligible Conditions
  • Intestinal stricture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635
8%
Syncope
8%
Colitis ulcerative
8%
Nasopharyngitis
4%
Anaemia
4%
Rash
4%
Infusion related reaction
4%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
300 mg Spesolimab (BI 655130) SD
1200 mg Spesolimab (BI 655130) q4w
450 mg Spesolimab (BI 655130) q4w

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpesolimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,549 Previous Clinical Trials
15,534,475 Total Patients Enrolled
~1 spots leftby Nov 2025
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