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

Last updated: January 7, 2021
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

4

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT02318667
8259-022
2014-003262-25
MK-8259-022
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inadequate response to conventional therapy including corticosteroids or areintolerant 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 thefirst 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 yearprior to study inclusion or a colonoscopy to exclude the presence of malignancy at thescreening visit
  • No history of untreated latent or active Tuberculosis (TB) prior to screening
  • Negative stool results for enteric pathogens

Exclusion

Exclusion Criteria:

  • History of asthma
  • History of autoimmune diseases
  • History of hypertension

Study Design

Total Participants: 38
Study Start date:
February 27, 2015
Estimated Completion Date:
September 05, 2017

Connect with a study center

  • Merck Sharp & Dohme Lda.

    Paco D'arcos,
    Portugal

    Site Not Available

  • Merck Sharp & Dohme Lda.

    Paco D`arcos,
    Portugal

    Site Not Available

  • Merck Sharp & Dohme Lda.

    Paco Darcos,
    Portugal

    Site Not Available

  • Merck Sharp & Dohme Lda.

    Paco De arcos,
    Portugal

    Site Not Available

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