Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02318667
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). EVOLUTION
• Scientific title: An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab.
• Date of first enrolment: February 27, 2015
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02318667
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Portugal

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Biological: Golimumab

Primary Outcome(s)

Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 6 [Time Frame: Week 6]

Correlation of Serum Soluble ST2 Levels With Endoscopic Activity of Disease (Assessed by Endoscopy Subscore of Mayo Score) at Week 6 [Time Frame: Week 6]

Serum ST2 Level at Week 6 [Time Frame: Week 6]

Secondary Outcome(s)

Correlation of Serum Soluble ST2 Levels With Clinical Activity (Assessed by Total Mayo Score) at Week 6 and Week 16 [Time Frame: Weeks 6 and 16]

Correlation of Endoscopic Mayo Subscore With Ulcerative Colitis Endoscopic Index Of Severity (UCEIS©) Overall Score at Week 6 and Week 16 [Time Frame: Week 6 and Week 16]

Correlation of Serum Soluble ST2 Levels With Faecal Calprotectin Levels at Baseline and Week 6 and Week 16 [Time Frame: Baseline, Weeks 6 and 16]

Serum ST2 Level at Week 16 [Time Frame: Week 16]

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) [Time Frame: Baseline, Week 6]

Change From Baseline to Week 6 in ST2 Levels in Participants With Active Versus Inactive UC [Time Frame: Baseline, Week 6]

Correlation of Serum Soluble ST2 Levels With Endoscopic Activity (Assessed by Endoscopy Subscore of Mayo Score) at Week 16 [Time Frame: Week 16]

Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 16 [Time Frame: Week 16]

Secondary ID(s)

MK-8259-022

2014-003262-25

8259-022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02318667