NCT04996797|CompletedPhase 2ResultsDMCFDA DrugFDA Device

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

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

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

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6 other identifiers

PR200-102MK-7240-005PRA0232023-509741-12-00U1111-1309-60782021-000091-11

Study Type

interventional

Target

178

Locations

12 countries

Sites

Timeline

RegisteredAug 2021

StartedJul 2021

CompletionJul 2025

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

178

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2021

Typical duration for phase_2

Geographic Reach

12 countries

88 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

July 14, 2021

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 27, 2024

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

August 2, 2021

Results QC Date

May 30, 2024

Last Update Submit

July 25, 2025

Conditions

Ulcerative Colitis

Keywords

ARTEMIS-UCARTEMISUlcerative Colitis

Outcome Measures

Primary Outcomes (4)

Percentage of Participants in Cohort 1 Achieving Clinical Remission
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)
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
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
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 Outcomes (15)

Percentage of Participants in Cohort 1 With Endoscopic Improvement
Baseline and Week 12
Percentage of Participants in Cohort 1 Achieving Clinical Response
Baseline and Week 12
Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
Baseline and Week 12
Percentage of Participants in Cohort 1 With Symptomatic Remission
Baseline and Week 12
Percentage of Participants in Cohort 1 With Histologic Improvement
Baseline and Week 12
+10 more secondary outcomes

Study Arms (4)

Cohort 1 Tulisokibart

EXPERIMENTAL

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

Cohort 1 Placebo

PLACEBO COMPARATOR

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

Cohort 2 Tulisokibart

EXPERIMENTAL

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.

Drug: TulisokibartDevice: Companion Diagnostic (CDx) Testing

Cohort 2 Placebo

PLACEBO COMPARATOR

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.

Device: Companion Diagnostic (CDx) TestingOther: Placebo

Interventions

TulisokibartDRUG

Administered by IV infusion

Also known as: MK-7240, PRA023

Cohort 1 TulisokibartCohort 2 Tulisokibart

Companion Diagnostic (CDx) TestingDEVICE

PRA023 CDx Genotyping Assay

Cohort 2 PlaceboCohort 2 Tulisokibart

PlaceboOTHER

Placebo administered by IV infusion

Cohort 1 PlaceboCohort 2 Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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