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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

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
State/province [17] 0 0
Washington
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno
Country [25] 0 0
Czechia
State/province [25] 0 0
Hradec Králové
Country [26] 0 0
Czechia
State/province [26] 0 0
Olomouc
Country [27] 0 0
Czechia
State/province [27] 0 0
Slaný
Country [28] 0 0
France
State/province [28] 0 0
Clichy
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Nice
Country [31] 0 0
France
State/province [31] 0 0
Pierre-Bénite
Country [32] 0 0
France
State/province [32] 0 0
Saint-Priest-en-Jarez
Country [33] 0 0
France
State/province [33] 0 0
Vandœuvre-lès-Nancy
Country [34] 0 0
Georgia
State/province [34] 0 0
Tbilisi
Country [35] 0 0
Hungary
State/province [35] 0 0
Gyor-Moson-Sopron
Country [36] 0 0
Hungary
State/province [36] 0 0
Bekescsaba
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Israel
State/province [38] 0 0
Afula
Country [39] 0 0
Israel
State/province [39] 0 0
Be'er Sheva
Country [40] 0 0
Israel
State/province [40] 0 0
H_olon
Country [41] 0 0
Israel
State/province [41] 0 0
Jerusalem
Country [42] 0 0
Israel
State/province [42] 0 0
Petah tikva
Country [43] 0 0
Italy
State/province [43] 0 0
Emilia-Romagna
Country [44] 0 0
Italy
State/province [44] 0 0
Milan
Country [45] 0 0
Italy
State/province [45] 0 0
Rome
Country [46] 0 0
Poland
State/province [46] 0 0
Greater Poland
Country [47] 0 0
Poland
State/province [47] 0 0
Kuuavian-Pomeranian
Country [48] 0 0
Poland
State/province [48] 0 0
Lesser Poland
Country [49] 0 0
Poland
State/province [49] 0 0
Lower Silesian
Country [50] 0 0
Poland
State/province [50] 0 0
Masovia
Country [51] 0 0
Poland
State/province [51] 0 0
Silesian
Country [52] 0 0
Poland
State/province [52] 0 0
Kraków
Country [53] 0 0
Poland
State/province [53] 0 0
Lublin
Country [54] 0 0
Poland
State/province [54] 0 0
Rzeszów
Country [55] 0 0
Poland
State/province [55] 0 0
Sopot
Country [56] 0 0
Poland
State/province [56] 0 0
Szczecin
Country [57] 0 0
Poland
State/province [57] 0 0
Torun
Country [58] 0 0
Poland
State/province [58] 0 0
Warsaw
Country [59] 0 0
Poland
State/province [59] 0 0
Wroclaw
Country [60] 0 0
Poland
State/province [60] 0 0
Lódz
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Merseyside
Country [62] 0 0
United Kingdom
State/province [62] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04996797