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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04996797
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Prometheus Biosciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Prometheus Biosciences
Principal Investigator Affiliation	Clinicaltrials Call center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, Czechia, France, Georgia, Hungary, Israel, Italy, Poland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis

Arms & Interventions

Arms

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.

Interventions

Drug: - PRA023 IV

PRA023 administered by IV infusion

Device: - Companion Diagnostic (CDx) Testing

PRA023 CDx Genotyping Assay

Other: - Placebo

Placebo administered by IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Prometheus Biosciences Selected Center, Mobile, Alabama

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Center

Mobile, Alabama, 36608

Site Contact

Prometheus Biosciences Call Center

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