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

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ClinicalTrials.gov Identifier: NCT04996797
Recruitment Status : Active, not recruiting
First Posted : August 9, 2021
Last Update Posted : January 16, 2024
Sponsor:
Information provided by (Responsible Party):
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: PRA023 IV Device: Companion Diagnostic (CDx) Testing Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 28, 2021
Actual Primary Completion Date : June 6, 2023
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 PRA023
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
 Drug: PRA023 IV
PRA023 administered by IV infusion
Placebo Comparator: Cohort 1 Placebo
Participant randomized to receive placebo administered by intravenous (IV) infusion.
 Other: Placebo
Placebo administered by IV infusion
Experimental: CDx+ Expansion Cohort PRA023
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
 Drug: PRA023 IV
PRA023 administered by IV infusion

Device: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Placebo Comparator: CDx+ Expansion Cohort Placebo
Participant randomized to receive placebo administered by intravenous (IV) infusion.
 Device: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay

Other: Placebo
Placebo administered by IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Induction of clinical remission [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of clinical remission

  2. Safety and tolerability [ Time Frame: Week 12 ]
    Incidence of AE, SAE, AE leading to discontinuation


Secondary Outcome Measures :
  1. Induction of endoscopic improvement [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of endoscopic improvement

  2. Induction of clinical response [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of clinical response

  3. Induction of clinical remission in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of clinical remission

  4. Induction of histologic remission [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of histologic remission

  5. Induction of histologic-endoscopic mucosal improvement [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of histologic- endoscopic mucosal improvement

  6. Induction of endoscopic improvement in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of endoscopic improvement

  7. Induction of clinical response in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of clinical response

  8. Induction of histologic remission in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of histologic remission

  9. Induction of histologic-endoscopic mucosal improvement in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of histologic-endoscopic mucosal

  10. Clinical remission in CDx+ vs. CDx- participants [ Time Frame: Week 12 ]
    Proportion of of CDx+ vs. CDx- participants achieving clinical remission

  11. Induction of mucosal healing [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of mucosal healing

  12. Induction of mucosal healing in CDx+ participants [ Time Frame: Week 12 ]
    Proportion of CDx+ participants achieving induction of mucosal healing

  13. Change in IBDQ [ Time Frame: Week 12 ]
    Change from Baseline in IBDQ through Week 12

  14. Change in IBDQ in CDx+ participants [ Time Frame: Week 12 ]
    Change from Baseline in IBDQ through Week 12 in CDx+ participants

  15. Induction of Clinical remission in CDx+ participants per alternative algorithm [ Time Frame: Week 12 ]
    Proportion of CDx+ participants per alternative algorithm achieving induction of Clinical remission.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04996797


Locations
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Sponsors and Collaborators
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Investigators
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Study Director: Prometheus Biosciences Clinicaltrials Call center
More Information
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Additional Information:

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Responsible Party: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
ClinicalTrials.gov Identifier: NCT04996797    
Other Study ID Numbers: PR200-102
2021-000091-11 ( EudraCT Number )
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: January 16, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA):
ARTEMIS-UC
ARTEMIS
Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases