A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Placebo; Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03123120

2016-004572-21 (EudraCT Number)

1368-0010

Details and patient eligibility

About

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 18 - 75 years at screening and randomisation
• Diagnosis of ulcerative colitis >= 5 months prior to screening
• Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4 months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation
• Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)
• Further inclusion criteria apply

Exclusion Criteria:

• Prior use of more than two different TNF inhibitors or vedolizumab
• Extensive colonic resection
• Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
• Active or latent tuberculosis
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

22 participants in 2 patient groups, including a placebo group

Spesolimab

Experimental group

Description:

1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).

Treatment:

Drug: Spesolimab

Placebo

Placebo Comparator group

Description:

Matching placebo was administered via intravenous infusion over 12 weeks of treatment.

Treatment:

Drug: Placebo