Phase 4
Completed N=38
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT02318667 ↗
Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Aug 2018
Primary outcomePrimary: Serum ST2 Level at Week 6 — 21.8 ng/mL
Summary
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe UC who have failed on prior conventional therapies. The primary endpoints of this study are to correlate serum soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and histological activity (Geboes index) of disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum ST2 Level at Week 6 |
21.8 | — |
| PRIMARY Correlation of Serum Soluble ST2 Levels With Endoscopic Activity of Disease (Assessed by Endoscopy Subscore of Mayo Score) at Week 6 |
0.451 | 0.0074 sig |
| PRIMARY Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 6 |
0.252 | 0.1506 |
| SECONDARY Serum ST2 Level at Week 16 |
17.9 | — |
| SECONDARY Correlation of Serum Soluble ST2 Levels With Endoscopic Activity (Assessed by Endoscopy Subscore of Mayo Score) at Week 16 |
0.268 | — |
| SECONDARY Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 16 |
0.177 | — |
| SECONDARY Correlation of Serum Soluble ST2 Levels With Faecal Calprotectin Levels at Baseline and Week 6 and Week 16 |
0.146; -0.022; -0.140 | — |
| SECONDARY Correlation of Serum Soluble ST2 Levels With Clinical Activity (Assessed by Total Mayo Score) at Week 6 and Week 16 |
0.404; 0.098 | — |
| SECONDARY Change From Baseline to Week 6 in ST2 Levels in Participants With Active Versus Inactive UC |
17.2; 25.0; -3.5; 2.4 | — |
| SECONDARY Change From Baseline to Week 6 in ST2 Level According to Participant's Mayo Endoscopic Response at Week 16 (Maintained Response at Week 16 or Did Not Maintain Response at Week 16) |
15.7; 21.0; -1.8; -7.8 | — |
| SECONDARY Correlation of Endoscopic Mayo Subscore With Ulcerative Colitis Endoscopic Index Of Severity (UCEIS©) Overall Score at Week 6 and Week 16 |
0.830; 0.875 | — |
Eligibility Criteria
Inclusion Criteria
- Inadequate response to conventional therapy including corticosteroids or are intolerant to, or have medical contraindications for conventional therapies
- UC diagnosed prior to screening, based on a biopsy collected at endoscopy
- Moderate to severe active UC with total Mayo score of 6 to 12, inclusive at baseline, and endoscopic Mayo sub-score, greater than or equal to 2
- Adenomatous polyps removed within last 5 years or at the screening visit prior to the first drug treatment
- Extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the screening visit
- No history of untreated latent or active Tuberculosis (TB) prior to screening
- Negative stool results for enteric pathogens
Exclusion Criteria
- History of asthma
- History of autoimmune diseases
- History of hypertension
Data sourced from ClinicalTrials.gov (NCT02318667). 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.