A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

  • STATUS
    Recruiting
  • End date
    Aug 15, 2030
  • participants needed
    20
  • sponsor
    Boehringer Ingelheim
Updated on 19 February 2021
remission
crohn's disease
fistulising crohn's disease

Summary

The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Spesolimab
Clinical Study IdentifierNCT04362254
SponsorBoehringer Ingelheim
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or Crohn's Disease?
Do you have any of these conditions: Crohn's Disease or Crohn's Disease (Pediatric) or crohns disease or Inflammatory bowel disease?
Do you have any of these conditions: Crohn's Disease or crohns disease or Inflammatory bowel disease or Crohn's Disease (Pediatric)?
Do you have any of these conditions: crohns disease or Crohn's Disease or Crohn's Disease (Pediatric) or Inflammatory bowel disease?
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or Crohn's Disease or crohns disease?
Do you have any of these conditions: Crohn's Disease (Pediatric) or crohns disease or Crohn's Disease or Inflammatory bowel disease?
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or crohns disease or Crohn's Disease?
Do you have any of these conditions: Inflammatory bowel disease or Crohn's Disease (Pediatric) or Crohn's Disease or crohns disease?
Do you have any of these conditions: Crohn's Disease (Pediatric) or crohns disease or Inflammatory bowel disease or Crohn's Disease?
Do you have any of these conditions: Inflammatory bowel disease or crohns disease or Crohn's Disease (Pediatric) or Crohn's Disease?
Patient older than 18 years
Has completed all treatments (placebo or active treatment) and the end of treatment (EOT) visit in the parent induction trial in fistulising Crohn's Disease (CD) and is willing and able to continue treatment in 1368-0007
Has obtained an individual health benefit, per investigator judgement (such as fistula response or remission or other clinical improvement), from treatment in the parent trial
Signed and dated written informed consent for 1368-0007 in accordance with GCP and local legislation prior to admission into the trial
Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria

Have experienced treatment-limiting adverse events during induction treatment with study drug
Have developed any condition which meets the exclusion criteria from the original induction study
Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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