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BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03648541
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 11, 2020
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the long-term safety of Spesolimab in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of Spesolimab in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Spesolimab IV infusion Drug: Spesolimab SC solution for injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Long Term Safety Trial of BI 655130 Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : March 30, 2031
Estimated Study Completion Date : March 30, 2031

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: All Patients
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
Drug: Spesolimab IV infusion
Solution for infusion

Drug: Spesolimab SC solution for injection
Solution for injection

Primary Outcome Measures :
  1. The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [ Time Frame: Up to week 336 ]

Secondary Outcome Measures :
  1. Proportion of patients with clinical remission [ Time Frame: Up to 336 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients, aged ≥18 years
  • Signed and dated written informed consent for 1368.17, 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. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.

Exclusion Criteria:

  • Have experienced study treatment-limiting adverse events during induction treatment with study drug
  • Have developed any of the exclusion criteria from the original induction study with the following exceptions:

    • Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17
    • Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03648541

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Contact: Boehringer Ingelheim 1-800-243-0127

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Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT03648541    
Other Study ID Numbers: 1368-0017
2018-000334-35 ( EudraCT Number )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases