Phase 3
Completed N=98
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03482635 ↗
Enrolled (actual)
98
Serious AEs
12.4%
Results posted
Jun 2021
Primary outcomePrimary: Proportion of Patients With Clinical Remission at Week 12 — 0.00; 0.042; 0.087; 0.071 Proportion of Participants
◆ Published Evidence
Not yet cited
0citations
Spesolimab use in generalised pustular psoriasis flares - Authors' reply.
Summary
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are
* to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
* to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
* To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.
Linked Publications
-
Spesolimab use in generalised pustular psoriasis flares - Authors' reply.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Clinical Remission at Week 12 |
0.00; 0.042; 0.087; 0.071 | — |
| SECONDARY Proportion of Patients With Clinical Response at Week 12 |
0.217; 0.167; 0.261; 0.250 | — |
| SECONDARY Proportion of Patients With Endoscopic Improvement at Week 12 |
0.000; 0.083; 0.087; 0.071 | — |
| SECONDARY Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12 |
0.00; 0.083; 0.043; 0.036 | — |
| SECONDARY Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12 |
19.8; 19.5; 21.2; 20.8 | 0.9776 |
Eligibility Criteria
Inclusion Criteria
- 18 - 75 years, at date of signing informed consent, males or females
- Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
- Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
- Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
- Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
- Further inclusion criteria apply
Exclusion Criteria
- Evidence of abdominal abscess at screening
- Evidence of fulminant colitis or toxic megacolon at screening
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03482635) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.