Clinical trial NCT04996797: A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: ARTEMIS-UC
ARTEMIS
Ulcerative Colitis
Lead sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants in Cohort 1 Achieving Clinical Remission
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to ~14 weeks
measure: Percentage of Participants Who Discontinued Due to an AE
timeFrame: Up to ~14 weeks
measure: Percentage of Participants Who Had One or More Serious Adverse Events
timeFrame: Up to ~14 weeks
Secondary outcomes:
measure: Percentage of Participants in Cohort 1 With Endoscopic Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 Achieving Clinical Response
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 With Symptomatic Remission
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 With Histologic Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing
timeFrame: Baseline and Week 12
measure: Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Prometheus Biosciences Selected Center
state: Alabama
city: Phoenix
country: United States
facility: Prometheus Biosciences Selected Site
state: Arizona
city: Sun City
country: United States
facility: Prometheus Biosciences Selected Site
state: Arizona
city: Los Angeles
country: United States
facility: Prometheus Biosciences Selected Site
state: California
city: Los Angeles
country: United States
facility: Prometheus Biosciences Selected Site
state: California
city: San Diego
country: United States
facility: Prometheus Biosciences Selected Site
state: California
city: Bristol
country: United States
facility: Prometheus Biosciences Selected Site
state: Connecticut
city: Atlanta
country: United States
facility: Prometheus Biosciences Selected Site
state: Georgia
city: Arlington Heights
country: United States
facility: Prometheus Biosciences Selected Site
state: Illinois
city: Glenview
country: United States
facility: Prometheus Biosciences Selected Site
state: Illinois
city: Gurnee
country: United States
facility: Prometheus Biosciences Selected Site
state: Illinois
city: Kansas City
country: United States
facility: Prometheus Biosciences Selected Site
state: Kansas
city: Liberty
country: United States
facility: Prometheus Biosciences Selected Site
state: Kansas
city: Baton Rouge
country: United States
facility: Prometheus Biosciences Selected Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Prometheus Biosciences Selected Site
state: Maryland
city: Chesterfield
country: United States
facility: Prometheus Biosciences Selected Site
state: Michigan
city: Lebanon
country: United States
facility: Prometheus Biosciences Selected Site
state: New Hampshire
city: New York
country: United States
facility: Prometheus Biosciences Selected Site
state: New York
city: New York
country: United States
facility: Prometheus Biosciences Selected Site
state: New York
city: Dublin
country: United States
facility: Prometheus Biosciences Selected Site
state: Ohio
city: Germantown
country: United States
facility: Prometheus Biosciences Selected Site
state: Tennessee
city: Bedford
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Lubbock
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Mansfield
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: San Antonio
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Southlake
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Tyler
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Charlottesville
country: United States
facility: Prometheus Biosciences Selected Site
state: Virginia
city: Tacoma
country: United States
facility: Prometheus Biosciences Selected Site
state: Washington
city: Woodville
country: Australia
facility: Prometheus Biosciences Selected Site
state: Adelaide
city: Kingswood
country: Australia
facility: Prometheus Biosciences Selected Site
state: New South Wales
city: Old Toongabbie
country: Australia
facility: Prometheus Biosciences Selected Site
state: New South Wales
city: South Brisbane
country: Australia
facility: Prometheus Biosciences Selected Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Prometheus Biosciences Selected Site
state: Queensland
city: Adelaide
country: Australia
facility: Prometheus Biosciences Selected Site
state: South Australia
city: Fitzroy
country: Australia
facility: Prometheus Biosciences Selected Site
state: Victoria
city: Melbourne
country: Australia
facility: Prometheus Biosciences Selected Site
state: Victoria
city: Leuven
country: Belgium
facility: Prometheus Biosciences Selected Site
city: Liège
country: Belgium
facility: Prometheus Biosciences Selected Site
city: Calgary
country: Canada
facility: Prometheus Biosciences Selected Site
state: Alberta
city: Vancouver
country: Canada
facility: Prometheus Biosciences Selected Site
state: British Columbia
city: Halifax
country: Canada
facility: Prometheus Biosciences Selected Site
state: Nova Scotia
city: North York
country: Canada
facility: Prometheus Biosciences Selected Site
state: Ontario
city: Brno
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Hradec Králové
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Olomouc
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Slaný
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Clichy
country: France
facility: Prometheus Biosciences Selected Site
city: Lille
country: France
facility: Prometheus Biosciences Selected Site
city: Nice
country: France
facility: Prometheus Biosciences Selected Site
city: Pierre-Bénite
country: France
facility: Prometheus Biosciences Selected Site
city: Saint-Priest-en-Jarez
country: France
facility: Prometheus Biosciences Selected Site
city: Vandœuvre-lès-Nancy
country: France
facility: Prometheus Biosciences Selected Site
city: Tbilisi
country: Georgia
facility: Prometheus Biosciences Selected Site
city: Győr
country: Hungary
facility: Prometheus Biosciences Selected Site
state: Gyor-Moson-Sopron
city: Bekescsaba
country: Hungary
facility: Prometheus Biosciences Selected Site
city: Budapest
country: Hungary
facility: Prometheus Biosciences Selected Site
city: Budapest
country: Hungary
facility: Prometheus Biosciences Selected Site
city: Budapest
country: Hungary
facility: Prometheus Biosciences Selected Center
city: Afula
country: Israel
facility: Prometheus Biosciences Selected Site
city: Be'er Sheva
country: Israel
facility: Prometheus Biosciences Selected Site
city: H̱olon
country: Israel
facility: Prometheus Biosciences Selected Site
city: Jerusalem
country: Israel
facility: Prometheus Biosciences Selected Site
city: Petah tikva
country: Israel
facility: Prometheus Biosciences Selected Site
city: Bologna
country: Italy
facility: Prometheus Biosciences Selected Site
state: Emilia-Romagna
city: Milano
country: Italy
facility: Prometheus Biosciences Selected Site
state: Milan
city: Milano
country: Italy
facility: Prometheus Biosciences Selected Site
state: Milan
city: Roma
country: Italy
facility: Prometheus Biosciences Selected Site
state: Rome
city: Poznań
country: Poland
facility: Prometheus Biosciences Selected Site
state: Greater Poland
city: Wloclawek
country: Poland
facility: Prometheus Biosciences Selected Site
state: Kuuavian-Pomeranian
city: Kraków
country: Poland
facility: Prometheus Biosciences Selected Site
state: Lesser Poland
city: Wrocław
country: Poland
facility: Prometheus Biosciences Selected Site
state: Lower Silesian
city: Wrocław
country: Poland
facility: Prometheus Biosciences Selected Site
state: Lower Silesian
city: Warszawa
country: Poland
facility: Prometheus Biosciences Selected Site
state: Masovia
city: Katowice
country: Poland
facility: Prometheus Biosciences Selected Site
state: Silesian
city: Kraków
country: Poland
facility: Prometheus Biosciences Selected Site
city: Lublin
country: Poland
facility: Prometheus Biosciences Selected Site
city: Lublin
country: Poland
facility: Prometheus Biosciences Selected Site
city: Rzeszów
country: Poland
facility: Prometheus Biosciences Selected Site
city: Sopot
country: Poland
facility: Prometheus Biosciences Selected Site
city: Szczecin
country: Poland
facility: Prometheus Biosciences Selected Site
city: Toruń
country: Poland
facility: Prometheus Biosciences Selected Site
city: Warsaw
country: Poland
facility: Prometheus Biosciences Selected Site #2
city: Warsaw
country: Poland
facility: Prometheus Biosciences Selected Site
city: Wrocław
country: Poland
facility: Prometheus Biosciences Selected Site
city: Łódź
country: Poland
facility: Prometheus Biosciences Selected Site
city: Prescot
country: United Kingdom
facility: Prometheus Biosciences Selected Site
state: Merseyside
city: London
country: United Kingdom
facility: Prometheus Biosciences Selected Sites
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, Rubin DT, Laurent O, Luo A, Nguyen DD, Lu J, Yen M, Leszczyszyn J, Kempinski R, McGovern DPB, Ma C, Ritter TE, Targan S; ARTEMIS-UC Study Group. Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. N Engl J Med. 2024 Sep 26;391(12):1119-1129. doi: 10.1056/NEJMoa2314076.