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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Colitis, Ulcerative

Treatments: Biological: Golimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318667

2014-003262-25 (EudraCT Number)

MK-8259-022 (Other Identifier)

8259-022

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Golimumab treatment

Experimental group

Description:

Golimumab 200 mg initially administered by subcutaneous (SC) injection at Week 0, followed by 100 mg at Week 2 and then 50 mg or 100 mg every 4 weeks (per prescribing information) up to 16 weeks.

Treatment:

Biological: Golimumab