A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— ARTEMIS-UC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04996797
• Other study ID #: PR200-102
• Secondary ID: 2021-000091-11
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: June 30, 2026
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• PRA023 IV
PRA023 administered by IV infusion

Device:
• Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay

Other:
• Placebo
Placebo administered by IV infusion

Locations

Country	Name	City	State
Australia	Prometheus Biosciences Selected Site	Adelaide	South Australia
Australia	Prometheus Biosciences Selected Site	Fitzroy	Victoria
Australia	Prometheus Biosciences Selected Site	Kingswood	New South Wales
Australia	Prometheus Biosciences Selected Site	Melbourne	Victoria
Australia	Prometheus Biosciences Selected Site	Old Toongabbie	New South Wales
Australia	Prometheus Biosciences Selected Site	South Brisbane	Queensland
Australia	Prometheus Biosciences Selected Site	Woodville	Adelaide
Australia	Prometheus Biosciences Selected Site	Woolloongabba	Queensland
Belgium	Prometheus Biosciences Selected Site	Leuven
Belgium	Prometheus Biosciences Selected Site	Liège
Canada	Prometheus Biosciences Selected Site	Calgary	Alberta
Canada	Prometheus Biosciences Selected Site	Halifax	Nova Scotia
Canada	Prometheus Biosciences Selected Site	North York	Ontario
Canada	Prometheus Biosciences Selected Site	Vancouver	British Columbia
Czechia	Prometheus Biosciences Selected Site	Brno
Czechia	Prometheus Biosciences Selected Site	Hradec Králové
Czechia	Prometheus Biosciences Selected Site	Olomouc
Czechia	Prometheus Biosciences Selected Site	Slaný
France	Prometheus Biosciences Selected Site	Clichy
France	Prometheus Biosciences Selected Site	Lille
France	Prometheus Biosciences Selected Site	Nice
France	Prometheus Biosciences Selected Site	Pierre-Bénite
France	Prometheus Biosciences Selected Site	Saint-Priest-en-Jarez
France	Prometheus Biosciences Selected Site	Vandœuvre-lès-Nancy
Georgia	Prometheus Biosciences Selected Site	Tbilisi
Hungary	Prometheus Biosciences Selected Site	Bekescsaba
Hungary	Prometheus Biosciences Selected Center	Budapest
Hungary	Prometheus Biosciences Selected Site	Budapest
Hungary	Prometheus Biosciences Selected Site	Budapest
Hungary	Prometheus Biosciences Selected Site	Gyor	Gyor-Moson-Sopron
Israel	Prometheus Biosciences Selected Site	Afula
Israel	Prometheus Biosciences Selected Site	Be'er Sheva
Israel	Prometheus Biosciences Selected Site	H_olon
Israel	Prometheus Biosciences Selected Site	Jerusalem
Israel	Prometheus Biosciences Selected Site	Petah tikva
Italy	Prometheus Biosciences Selected Site	Bologna	Emilia-Romagna
Italy	Prometheus Biosciences Selected Site	Milano	Milan
Italy	Prometheus Biosciences Selected Site	Milano	Milan
Italy	Prometheus Biosciences Selected Site	Roma	Rome
Poland	Prometheus Biosciences Selected Site	Katowice	Silesian
Poland	Prometheus Biosciences Selected Site	Kraków
Poland	Prometheus Biosciences Selected Site	Kraków	Lesser Poland
Poland	Prometheus Biosciences Selected Site	Lódz
Poland	Prometheus Biosciences Selected Site	Lublin
Poland	Prometheus Biosciences Selected Site	Lublin
Poland	Prometheus Biosciences Selected Site	Poznan	Greater Poland
Poland	Prometheus Biosciences Selected Site	Rzeszów
Poland	Prometheus Biosciences Selected Site	Sopot
Poland	Prometheus Biosciences Selected Site	Szczecin
Poland	Prometheus Biosciences Selected Site	Torun
Poland	Prometheus Biosciences Selected Site	Warsaw
Poland	Prometheus Biosciences Selected Site #2	Warsaw
Poland	Prometheus Biosciences Selected Site	Warszawa	Masovia
Poland	Prometheus Biosciences Selected Site	Wloclawek	Kuuavian-Pomeranian
Poland	Prometheus Biosciences Selected Site	Wroclaw
Poland	Prometheus Biosciences Selected Site	Wroclaw	Lower Silesian
Poland	Prometheus Biosciences Selected Site	Wroclaw	Lower Silesian
United Kingdom	Prometheus Biosciences Selected Sites	London
United Kingdom	Prometheus Biosciences Selected Site	Prescot	Merseyside
United States	Prometheus Biosciences Selected Site	Arlington Heights	Illinois
United States	Prometheus Biosciences Selected Site	Atlanta	Georgia
United States	Prometheus Biosciences Selected Site	Baton Rouge	Louisiana
United States	Prometheus Biosciences Selected Site	Bedford	Texas
United States	Prometheus Biosciences Selected Site	Bristol	Connecticut
United States	Prometheus Biosciences Selected Site	Charlottesville	Virginia
United States	Prometheus Biosciences Selected Site	Chesterfield	Michigan
United States	Prometheus Biosciences Selected Site	Chevy Chase	Maryland
United States	Prometheus Biosciences Selected Site	Dublin	Ohio
United States	Prometheus Biosciences Selected Site	Germantown	Tennessee
United States	Prometheus Biosciences Selected Site	Glenview	Illinois
United States	Prometheus Biosciences Selected Site	Gurnee	Illinois
United States	Prometheus Biosciences Selected Site	Kansas City	Kansas
United States	Prometheus Biosciences Selected Site	Lebanon	New Hampshire
United States	Prometheus Biosciences Selected Site	Liberty	Kansas
United States	Prometheus Biosciences Selected Site	Los Angeles	California
United States	Prometheus Biosciences Selected Site	Los Angeles	California
United States	Prometheus Biosciences Selected Site	Lubbock	Texas
United States	Prometheus Biosciences Selected Site	Mansfield	Texas
United States	Prometheus Biosciences Selected Center	Mobile	Alabama
United States	Prometheus Biosciences Selected Site	New York	New York
United States	Prometheus Biosciences Selected Site	New York	New York
United States	Prometheus Biosciences Selected Site	Phoenix	Arizona
United States	Prometheus Biosciences Selected Site	San Antonio	Texas
United States	Prometheus Biosciences Selected Site	San Diego	California
United States	Prometheus Biosciences Selected Site	Southlake	Texas
United States	Prometheus Biosciences Selected Site	Sun City	Arizona
United States	Prometheus Biosciences Selected Site	Tacoma	Washington
United States	Prometheus Biosciences Selected Site	Tyler	Texas

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Georgia,  Hungary,  Israel,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction of clinical remission	Proportion of participants achieving induction of clinical remission	Week 12
Primary	Safety and tolerability	Incidence of AE, SAE, AE leading to discontinuation	Week 12
Secondary	Induction of endoscopic improvement	Proportion of participants achieving induction of endoscopic improvement	Week 12
Secondary	Induction of clinical response	Proportion of participants achieving induction of clinical response	Week 12
Secondary	Induction of clinical remission in CDx+ participants	Proportion of CDx+ participants achieving induction of clinical remission	Week 12
Secondary	Induction of histologic remission	Proportion of participants achieving induction of histologic remission	Week 12
Secondary	Induction of histologic-endoscopic mucosal improvement	Proportion of participants achieving induction of histologic- endoscopic mucosal improvement	Week 12
Secondary	Induction of endoscopic improvement in CDx+ participants	Proportion of CDx+ participants achieving induction of endoscopic improvement	Week 12
Secondary	Induction of clinical response in CDx+ participants	Proportion of CDx+ participants achieving induction of clinical response	Week 12
Secondary	Induction of histologic remission in CDx+ participants	Proportion of CDx+ participants achieving induction of histologic remission	Week 12
Secondary	Induction of histologic-endoscopic mucosal improvement in CDx+ participants	Proportion of CDx+ participants achieving induction of histologic-endoscopic mucosal	Week 12
Secondary	Clinical remission in CDx+ vs. CDx- participants	Proportion of of CDx+ vs. CDx- participants achieving clinical remission	Week 12
Secondary	Induction of mucosal healing	Proportion of participants achieving induction of mucosal healing	Week 12
Secondary	Induction of mucosal healing in CDx+ participants	Proportion of CDx+ participants achieving induction of mucosal healing	Week 12
Secondary	Change in IBDQ	Change from Baseline in IBDQ through Week 12	Week 12
Secondary	Change in IBDQ in CDx+ participants	Change from Baseline in IBDQ through Week 12 in CDx+ participants	Week 12
Secondary	Induction of Clinical remission in CDx+ participants per alternative algorithm	Proportion of CDx+ participants per alternative algorithm achieving induction of Clinical remission.	Week 12

External Links

•   Merck Clinical Trials Information