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Monoclonal Antibodies

Spesolimab IV infusion for Ulcerative Colitis

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 week 336
Awards & highlights

Study Summary

This trial is looking at the long-term safety and efficacy of a drug called BI 655130 (SPESOLIMAB) in patients with ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 336
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 336 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)
Secondary outcome measures
Proportion of patients with clinical remission

Trial Design

1Treatment groups
Experimental Treatment
Group I: All PatientsExperimental Treatment2 Interventions
1 arm solution for injection Spesolimab will be used for all patients. Those who did not respond to previous induction treatment or experienced disease flare will need i.v. re-induction treatment also
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab IV infusion
2018
Completed Phase 2
~80
Spesolimab SC solution for injection
2018
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar treatments to Spesolimab IV infusion that have been trialed?

"Spesolimab IV infusion was first researched at Tokyo Medical and Dental University in 2018. So far, there have been 17 completed clinical trials with 5 active studies currently underway. A majority of these ongoing investigations are based out of Southlake, Texas."

Answered by AI

What is the total enrollment for this clinical research?

"Unfortunately, this particular clinical trial is not presently enrolling patients. The study was first posted on October 29th, 2018 and was last edited on November 16th, 2020. If you are looking for other trials, there are currently 416 active clinical trials related to colitis and 5 trials for Spesolimab IV infusion that are admitting patients."

Answered by AI

Do we have any previous case studies to reference with this type of treatment?

"There are presently 5 live trials for Spesolimab IV infusion across 37 cities and 36 countries. The initial trial for Spesolimab IV infusion occurred in 2018. The study, sponsored by Boehringer Ingelheim, involved 79 participants and completed its Phase 2 drug approval stage. Since 2018 years, 17 trials have been completed."

Answered by AI

When was Spesolimab given the green light by the FDA?

"Spesolimab IV infusion is currently in Phase 2 of clinical trials. Although there is some evidence suggesting it is safe, more data needs to be collected to confirm its efficacy."

Answered by AI

Where are patients able to enroll in this clinical trial?

"To make travel easier for potential participants, the 9 sites for this clinical trial are located in or near Southlake, Oklahoma City and San Antonio."

Answered by AI

Are there any available positions for participants in this experiment?

"As of November 16th, 2022, this clinical trial is not recruiting patients. The study was initially posted on October 29th, 2018. However, there are other ongoing research projects that might be of interest. There are a total of 416 trials actively recruiting patients with colitis and 5 for Spesolimab IV infusion."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
2018. "BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03648541.
~12 spots leftby Apr 2025
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