A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis (ARTEMIS-UC)

  • STATUS
    Recruiting
  • End date
    Nov 5, 2023
  • participants needed
    170
  • sponsor
    Prometheus Biosciences, Inc.
Updated on 5 June 2022
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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.

Details
Condition Ulcerative Colitis
Treatment Placebo, PRA023 IV, Companion Diagnostic (CDx) Testing
Clinical Study IdentifierNCT04996797
SponsorPrometheus Biosciences, Inc.
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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