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

  • Interventional
  • Recruiting
  • NCT03648541
Eligibility Details Visit Clinicaltrials.gov

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

To evaluate the long-term safety of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Gender
All

Age Group
18 Years and up

Accepting 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

At a Glance

National Government IDNCT03648541

IRB#IRB18-1458

Lead SponsorBoehringer Ingelheim

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting