Addition of Baseline Histology and Fecal Calprotectin Does Not Reduce Placebo Rates in Ulcerative Colitis Clinical Trials: Post-hoc Analysis of Patient Level Data

Restricting trial enrollment based on elevated FC or histological activity did not meaningfully lower placebo response rates in phase 3 UC trials.

Authors

Emily C L Wong (ORCID: https://orcid.org/0000-0001-9472-201X)
Vipul Jairath (ORCID: https://orcid.org/0000-0001-8603-898X)
Walter Reinisch (ORCID: https://orcid.org/0000-0002-2088-091X)
John K. Marshall (ORCID: https://orcid.org/0000-0002-0523-9032)
Parambir S. Dulai (ORCID: https://orcid.org/0000-0002-9514-2321)
Neeraj Narula (ORCID: https://orcid.org/0000-0002-1536-8436)
Christopher Ma (ORCID: https://orcid.org/0000-0002-4698-9948)

Institutions

Northwestern University (US)
Western University (CA)
University of Calgary (CA)
Population Health Research Institute (CA)
Northwestern University (PH)
Institut de Recherche en Santé Digestive (FR)
Northwestern Medicine (US)
Medical University of Vienna (AT)
McMaster University (CA)

Publication Details

Journal: Journal of Crohn s and Colitis
Published: 2025-11-07
DOI: https://doi.org/10.1093/ecco-jcc/jjaf194
Primary Topic: Inflammatory Bowel Disease
Type: article
Field-Weighted Citation Impact: 0.00

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article

Addition of Baseline Histology and Fecal Calprotectin Does Not Reduce Placebo Rates in Ulcerative Colitis Clinical Trials: Post-hoc Analysis of Patient Level Data

Emily C L Wong, Vipul Jairath, Walter Reinisch, John K. Marshall et al.

Nov 7, 2025

Journal of Crohn s and Colitis

Inflammatory Bowel Disease

article

Addition of Baseline Histology and Fecal Calprotectin Does Not Reduce Placebo Rates in Ulcerative Colitis Clinical Trials: Post-hoc Analysis of Patient Level Data

Emily C L Wong, Vipul Jairath, Walter Reinisch, John K. Marshall, Parambir S. Dulai, Neeraj Narula, Christopher Ma

November 7, 2025article en

Abstract

Restricting trial enrollment based on elevated FC or histological activity did not meaningfully lower placebo response rates in phase 3 UC trials.

Journal of Crohn s and ColitisVol. 19(10)

Northwestern University (US), Western University (CA), University of Calgary (CA), Population Health Research Institute (CA), Northwestern University (PH), Institut de Recherche en Santé Digestive (FR), Northwestern Medicine (US), Medical University of Vienna (AT), McMaster University (CA)

Openalex Percentile: Top 64%

Inflammatory Bowel Disease

DOI Open Access PDF OpenAlex

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Addition of Baseline Histology and Fecal Calprotectin Does Not Reduce Placebo Rates in Ulcerative Colitis Clinical Trials: Post-hoc Analysis of Patient Level Data — Emily C L Wong, Vipul Jairath, et al. · Journal of Crohn s and Colitis (2025) | TGRS Research Map | TGRS