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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03648541

1368-0017

2018-000334-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

79 participants in 2 patient groups

Spesolimab IV infusion

Experimental group

Description:

Spesolimab IV infusion

Treatment:

Drug: Spesolimab

Spesolimab SC solution for injection

Experimental group

Description:

Spesolimab SC solution for injection

Treatment:

Drug: Spesolimab