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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04996797




Registration number
NCT04996797
Ethics application status
Date submitted
2/08/2021
Date registered
9/08/2021
Date last updated
16/01/2024

Titles & IDs
Public title
A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
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
2021-000091-11
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 - PRA023 IV
Treatment: Devices - Companion Diagnostic (CDx) Testing
Other interventions - Placebo

Experimental: Cohort 1 PRA023 - Participants randomized to receive PRA023 administered by intravenous (IV) infusion.

Placebo Comparator: Cohort 1 Placebo - Participant randomized to receive placebo administered by intravenous (IV) infusion.

Experimental: CDx+ Expansion Cohort PRA023 - Participants randomized to receive PRA023 administered by intravenous (IV) infusion.

Placebo Comparator: CDx+ Expansion Cohort Placebo - Participant randomized to receive placebo administered by intravenous (IV) infusion.


Treatment: Drugs: PRA023 IV
PRA023 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
Induction of clinical remission
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Safety and tolerability
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Induction of endoscopic improvement
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Induction of clinical response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Induction of clinical remission in CDx+ participants
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Induction of histologic remission
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Induction of histologic-endoscopic mucosal improvement
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Induction of endoscopic improvement in CDx+ participants
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Induction of clinical response in CDx+ participants
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Induction of histologic remission in CDx+ participants
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Induction of histologic-endoscopic mucosal improvement in CDx+ participants
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Clinical remission in CDx+ vs. CDx- participants
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Induction of mucosal healing
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Induction of mucosal healing in CDx+ participants
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Change in IBDQ
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Change in IBDQ in CDx+ participants
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Induction of Clinical remission in CDx+ participants per alternative algorithm
Timepoint [15] 0 0
Week 12

Eligibility
Key inclusion criteria
- Confirmed diagnosis of ulcerative colitis (UC)

- 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-TNF, anti-integrin,
anti-IL12/23, JAK inhibitor, S1PR modulator.

- Able to provide written informed consent and understand and comply with the
requirements of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- WOCBP and men with female partners of childbearing potential who are unwilling or
unable to use two highly effective methods of contraception to avoid pregnancy for the
entire study period and for up to 12 weeks after the last dose of study drug

- Diagnosis of Crohn's disease or indeterminate colitis

- Current evidence of fulminant colitis, toxic megacolon, bowel perforation, total
proctocoloectomy or partial colectomy

- Current or impending need for colostomy or ileostomy

- Surgical bowel resection within 3 months before screening

- Past or current evidence of definite low-grade or high-grade colonic dysplasia not
completely removed

- Subjects in the opinion of the investigator are at an unacceptable risk for
participation in the study

- Subjects who meet the protocol criteria for important laboratory exclusion criteria

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
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United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
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United States of America
State/province [15] 0 0
Texas
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United States of America
State/province [16] 0 0
Virginia
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United States of America
State/province [17] 0 0
Washington
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Belgium
State/province [18] 0 0
Leuven
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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
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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
State/province [34] 0 0
Tbilisi
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Hungary
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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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Poland
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Greater Poland
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Poland
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Kuuavian-Pomeranian
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Poland
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Lesser Poland
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Poland
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Lower Silesian
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Masovia
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Poland
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Silesian
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Poland
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Kraków
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Poland
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Lublin
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Rzeszów
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Sopot
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Szczecin
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Torun
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Warsaw
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Poland
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Wroclaw
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Poland
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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 PRA023 in participants with
moderately to severely active Ulcerative Colitis.

The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in
participants with moderately to severely active ulcerative colitis who are companion
diagnostic positive.

After the completion of the 12-week induction, all participants have the option to continue
in the open-label extension for another 38 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04996797
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prometheus Biosciences
Address 0 0
Clinicaltrials Call center
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