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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04996797




Registration number
NCT04996797
Ethics application status
Date submitted
2/08/2021
Date registered
9/08/2021
Date last updated
30/07/2024

Titles & IDs
Public title
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
Scientific 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
Secondary ID [1] 0 0
MK-7240-005
Secondary ID [2] 0 0
PR200-102
Universal Trial Number (UTN)
Trial acronym
ARTEMIS-UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tulisokibart
Treatment: Devices - Companion Diagnostic (CDx) Testing
Other interventions - Placebo

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.

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.

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.

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.


Treatment: Drugs: Tulisokibart
Administered by IV infusion

Treatment: Devices: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay

Other interventions: Placebo
Placebo administered by IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Cohort 1 Achieving Clinical Remission
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Up to ~14 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Discontinued Due to an AE
Timepoint [3] 0 0
Up to ~14 weeks
Primary outcome [4] 0 0
Percentage of Participants Who Had One or More Serious Adverse Events
Timepoint [4] 0 0
Up to ~14 weeks
Secondary outcome [1] 0 0
Percentage of Participants in Cohort 1 With Endoscopic Improvement
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percentage of Participants in Cohort 1 Achieving Clinical Response
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Percentage of Participants in Cohort 1 With Symptomatic Remission
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percentage of Participants in Cohort 1 With Histologic Improvement
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement
Timepoint [10] 0 0
Baseline and Week 12
Secondary outcome [11] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement
Timepoint [11] 0 0
Baseline and Week 12
Secondary outcome [12] 0 0
Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing
Timepoint [12] 0 0
Baseline and Week 12
Secondary outcome [13] 0 0
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing
Timepoint [13] 0 0
Baseline and Week 12
Secondary outcome [14] 0 0
Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response
Timepoint [14] 0 0
Baseline and Week 12
Secondary outcome [15] 0 0
Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response
Timepoint [15] 0 0
Baseline and Week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
AdelaideNSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prometheus Biosciences Selected Site - Woodville
Recruitment hospital [2] 0 0
Prometheus Biosciences Selected Site - Kingswood
Recruitment hospital [3] 0 0
Prometheus Biosciences Selected Site - Old Toongabbie
Recruitment hospital [4] 0 0
Prometheus Biosciences Selected Site - South Brisbane
Recruitment hospital [5] 0 0
Prometheus Biosciences Selected Site - Woolloongabba
Recruitment hospital [6] 0 0
Prometheus Biosciences Selected Site - Adelaide
Recruitment hospital [7] 0 0
Prometheus Biosciences Selected Site - Fitzroy
Recruitment hospital [8] 0 0
Prometheus Biosciences Selected Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Woodville
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
NSW 2146 - Old Toongabbie
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
VIC 3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
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Washington
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Belgium
State/province [18] 0 0
Leuven
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Belgium
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Liège
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Canada
State/province [20] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Hradec Králové
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Czechia
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Olomouc
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Czechia
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Slaný
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France
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Clichy
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France
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Lille
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France
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Nice
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France
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Pierre-Bénite
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France
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Saint-Priest-en-Jarez
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France
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Vandœuvre-lès-Nancy
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Georgia
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Tbilisi
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Gyor-Moson-Sopron
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Israel
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Afula
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Israel
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Be'er Sheva
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Israel
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H_olon
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Israel
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Jerusalem
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Israel
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Petah tikva
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Italy
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Emilia-Romagna
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Italy
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Milan
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Italy
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Rome
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Greater Poland
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Kuuavian-Pomeranian
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Lesser Poland
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Lower Silesian
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Masovia
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Silesian
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Kraków
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Lublin
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Rzeszów
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Sopot
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Torun
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Warsaw
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Wroclaw
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Lódz
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United Kingdom
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Merseyside
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04996797
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04996797