A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005) (ARTEMIS-UC)

July 25, 2025 updated by: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Adelaide
      • Woodville, Adelaide, Australia
        • Prometheus Biosciences Selected Site
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Prometheus Biosciences Selected Site
      • Old Toongabbie, New South Wales, Australia, NSW 2146
        • Prometheus Biosciences Selected Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Prometheus Biosciences Selected Site
      • Woolloongabba, Queensland, Australia, 4102
        • Prometheus Biosciences Selected Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Prometheus Biosciences Selected Site
    • Victoria
      • Fitzroy, Victoria, Australia, VIC 3065
        • Prometheus Biosciences Selected Site
      • Melbourne, Victoria, Australia, VIC 3065
        • Prometheus Biosciences Selected Site
  • Belgium
      • Leuven, Belgium, 3000
        • Prometheus Biosciences Selected Site
      • Liège, Belgium, 4000
        • Prometheus Biosciences Selected Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Prometheus Biosciences Selected Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2K5
        • Prometheus Biosciences Selected Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Prometheus Biosciences Selected Site
    • Ontario
      • North York, Ontario, Canada, M6A 3B4
        • Prometheus Biosciences Selected Site
  • Czechia
      • Brno, Czechia
        • Prometheus Biosciences Selected Site
      • Hradec Králové, Czechia
        • Prometheus Biosciences Selected Site
      • Olomouc, Czechia, 779 00
        • Prometheus Biosciences Selected Site
      • Slaný, Czechia
        • Prometheus Biosciences Selected Site
  • France
      • Clichy, France, 92110
        • Prometheus Biosciences Selected Site
      • Lille, France, 59037
        • Prometheus Biosciences Selected Site
      • Nice, France, 06202
        • Prometheus Biosciences Selected Site
      • Pierre-Bénite, France, 69495
        • Prometheus Biosciences Selected Site
      • Saint-Priest-en-Jarez, France, 42270
        • Prometheus Biosciences Selected Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Prometheus Biosciences Selected Site
  • Georgia
      • Tbilisi, Georgia
        • Prometheus Biosciences Selected Site
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Prometheus Biosciences Selected Site
      • Budapest, Hungary, 1062
        • Prometheus Biosciences Selected Site
      • Budapest, Hungary, 1088
        • Prometheus Biosciences Selected Site
      • Budapest, Hungary, 1135
        • Prometheus Biosciences Selected Center
    • Gyor-Moson-Sopron
      • Győr, Gyor-Moson-Sopron, Hungary, 9024
        • Prometheus Biosciences Selected Site
  • Israel
      • Afula, Israel, 18341
        • Prometheus Biosciences Selected Site
      • Be'er Sheva, Israel, 84100
        • Prometheus Biosciences Selected Site
      • H̱olon, Israel, 58100
        • Prometheus Biosciences Selected Site
      • Jerusalem, Israel, 91031
        • Prometheus Biosciences Selected Site
      • Petah tikva, Israel, 49414
        • Prometheus Biosciences Selected Site
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Prometheus Biosciences Selected Site
    • Milan
      • Milano, Milan, Italy, 20132
        • Prometheus Biosciences Selected Site
      • Milano, Milan, Italy, 20157
        • Prometheus Biosciences Selected Site
    • Rome
      • Roma, Rome, Italy, 00168
        • Prometheus Biosciences Selected Site
  • Poland
      • Kraków, Poland
        • Prometheus Biosciences Selected Site
      • Lublin, Poland, 20-362
        • Prometheus Biosciences Selected Site
      • Lublin, Poland, 20-607
        • Prometheus Biosciences Selected Site
      • Rzeszów, Poland
        • Prometheus Biosciences Selected Site
      • Sopot, Poland
        • Prometheus Biosciences Selected Site
      • Szczecin, Poland
        • Prometheus Biosciences Selected Site
      • Toruń, Poland
        • Prometheus Biosciences Selected Site
      • Warsaw, Poland
        • Prometheus Biosciences Selected Site #2
      • Warsaw, Poland
        • Prometheus Biosciences Selected Site
      • Wrocław, Poland
        • Prometheus Biosciences Selected Site
      • Łódź, Poland, 93-357
        • Prometheus Biosciences Selected Site
    • Greater Poland
      • Poznań, Greater Poland, Poland, 61-441
        • Prometheus Biosciences Selected Site
    • Kuuavian-Pomeranian
      • Wloclawek, Kuuavian-Pomeranian, Poland, 87-800
        • Prometheus Biosciences Selected Site
    • Lesser Poland
      • Kraków, Lesser Poland, Poland, 31-009
        • Prometheus Biosciences Selected Site
    • Lower Silesian
      • Wrocław, Lower Silesian, Poland, 40-211
        • Prometheus Biosciences Selected Site
      • Wrocław, Lower Silesian, Poland, 540144
        • Prometheus Biosciences Selected Site
    • Masovia
      • Warszawa, Masovia, Poland, 04-730
        • Prometheus Biosciences Selected Site
    • Silesian
      • Katowice, Silesian, Poland, 40-211
        • Prometheus Biosciences Selected Site
  • United Kingdom
      • London, United Kingdom, E11 1NR
        • Prometheus Biosciences Selected Sites
    • Merseyside
      • Prescot, Merseyside, United Kingdom, L34 1BH
        • Prometheus Biosciences Selected Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Prometheus Biosciences Selected Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Prometheus Biosciences Selected Site
      • Sun City, Arizona, United States, 85351
        • Prometheus Biosciences Selected Site
    • California
      • Los Angeles, California, United States, 90045
        • Prometheus Biosciences Selected Site
      • Los Angeles, California, United States, 90048
        • Prometheus Biosciences Selected Site
      • San Diego, California, United States, 92037
        • Prometheus Biosciences Selected Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Prometheus Biosciences Selected Site
    • Georgia
      • Atlanta, Georgia, United States, 30010
        • Prometheus Biosciences Selected Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Prometheus Biosciences Selected Site
      • Glenview, Illinois, United States, 60026
        • Prometheus Biosciences Selected Site
      • Gurnee, Illinois, United States, 60031
        • Prometheus Biosciences Selected Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Prometheus Biosciences Selected Site
      • Liberty, Kansas, United States, 64098
        • Prometheus Biosciences Selected Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Prometheus Biosciences Selected Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Prometheus Biosciences Selected Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Prometheus Biosciences Selected Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Prometheus Biosciences Selected Site
    • New York
      • New York, New York, United States, 10065
        • Prometheus Biosciences Selected Site
      • New York, New York, United States, 10029
        • Prometheus Biosciences Selected Site
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Prometheus Biosciences Selected Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Prometheus Biosciences Selected Site
    • Texas
      • Bedford, Texas, United States, 76022
        • Prometheus Biosciences Selected Site
      • Lubbock, Texas, United States, 79424
        • Prometheus Biosciences Selected Site
      • Mansfield, Texas, United States, 76063
        • Prometheus Biosciences Selected Site
      • San Antonio, Texas, United States, 78229
        • Prometheus Biosciences Selected Site
      • Southlake, Texas, United States, 76092
        • Prometheus Biosciences Selected Site
      • Tyler, Texas, United States, 75702
        • Prometheus Biosciences Selected Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Prometheus Biosciences Selected Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Prometheus Biosciences Selected Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Confirmed diagnosis of ulcerative colitis (UC)
  • Has moderately to severely active UC as defined by 3-component Modified Mayo score
  • Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has diagnosis of Crohn's disease or indeterminate colitis
  • Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
  • Has current or impending need for colostomy or ileostomy
  • Has had surgical bowel resection within 3 months before screening
  • Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 Tulisokibart
Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Drug: Tulisokibart
Administered by IV infusion
Other Names:
  • PRA023
  • MK-7240
Placebo Comparator: Cohort 1 Placebo
Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Other: Placebo
Placebo administered by IV infusion
Experimental: Cohort 2 Tulisokibart
Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Device: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Drug: Tulisokibart
Administered by IV infusion
Other Names:
  • PRA023
  • MK-7240
Placebo Comparator: Cohort 2 Placebo
Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Other: Placebo
Placebo administered by IV infusion
Device: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Cohort 1 Achieving Clinical Remission
Time Frame: Baseline and Week 12
The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to ~14 weeks
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who experienced at least one AE is reported.
Up to ~14 weeks
Percentage of Participants Who Discontinued Due to an AE
Time Frame: Up to ~14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who discontinued due to an AE is reported.
Up to ~14 weeks
Percentage of Participants Who Had One or More Serious Adverse Events
Time Frame: Up to ~14 weeks
Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Serious adverse events are defined as: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Life-threatening consequences; urgent intervention indicated, and death. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants experiencing a serious AE are presented.
Up to ~14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Cohort 1 With Endoscopic Improvement
Time Frame: Baseline and Week 12
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of the MMS of ≤ 1 with no friability. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 Achieving Clinical Response
Time Frame: Baseline and Week 12
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined as a reduction from Baseline ≥ 2 points and ≥ 30% in 3-component Modified Mayo Score, accompanied by a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
Time Frame: Baseline and Week 12
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 With Symptomatic Remission
Time Frame: Baseline and Week 12
RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement
Time Frame: Baseline and Week 12
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of MMS of ≤ 1 with no friability. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response
Time Frame: Baseline and Week 12
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined by reduction from Baseline ≥ 2 points and ≥ 30% in 3-component Modified Mayo Score, accompanied by a reduction ≥ 1 in RB subscore or absolute RB subscore ≤ 1. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission
Time Frame: Baseline and Week 12
RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response
Time Frame: Baseline and Week 12
IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by ≥ 16-point increase from Baseline at Week 12. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response
Time Frame: Baseline and Week 12
IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by ≥ 16-point increase from Baseline at Week 12. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 With Histologic Improvement
Time Frame: Baseline and Week 12
Histologic improvement is defined as Geboes score ≤ 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement
Time Frame: Baseline and Week 12
Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopy subscore of the MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement
Time Frame: Baseline and Week 12
Histologic improvement is defined as Geboes score ≤ 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement
Time Frame: Baseline and Week 12
Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopy subscore of the MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing
Time Frame: Baseline and Week 12
Histologic-endoscopic mucosal improvement is defined as Geboes score ≤ 2B.1 and endoscopy subscore of MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing
Time Frame: Baseline and Week 12
Histologic-endoscopic mucosal improvement is defined as Geboes score ≤ 2B.1 and endoscopy subscore of MMS ≤ 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Actual)

June 6, 2023

Study Completion (Actual)

July 14, 2025

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR200-102
  • 2021-000091-11 (EudraCT Number)
  • MK-7240-005 (Other Identifier: MSD ID)
  • PRA023 (Other Identifier: Prometheus Biosciences)
  • 2023-509741-12-00 (Registry Identifier: EU CT)
  • U1111-1309-6078 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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