A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

Study Purpose

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week induction period, 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 Crohn's disease.
  • - Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy.
  • - 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-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23.
  • - Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion Criteria:

  • - Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug.
  • - Diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  • - CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement.
  • - Suspected or diagnosed intra-abdominal or perianal abscess at screening.
  • - Current stoma or need for colostomy or ileostomy.
  • - Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments.
  • - 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.

NCT05013905
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, Poland, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Experimental: PRA023

Participants to receive PRA023 administered by intravenous (IV) infusion.

Interventions

Drug: - PRA023 IV

PRA023 administered at timepoints as directed by the protocol

Device: - Companion diagnostic (CDx)

CDx+ or CDx-

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 Site, Los Angeles, California

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Los Angeles, California, 90045

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Los Angeles, California

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Los Angeles, California, 90048

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Liberty, Kansas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Liberty, Kansas, 64098

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Chesterfield, Michigan

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Chesterfield, Michigan, 48047

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Ypsilanti, Michigan

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Ypsilanti, Michigan, 48197

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Saint Louis, Missouri

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Saint Louis, Missouri, 63141

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Lebanon, New Hampshire

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Lebanon, New Hampshire, 03756

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, New York, New York

Status

Recruiting

Address

Prometheus Biosciences Selected Site

New York, New York, 10065

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Garland, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Garland, Texas, 75044

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Lubbock, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Lubbock, Texas, 79410

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Lubbock, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Lubbock, Texas, 79424

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, San Antonio, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

San Antonio, Texas, 78229

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Southlake, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Southlake, Texas, 78229

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Tyler, Texas

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Tyler, Texas, 75702

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Bellevue, Washington

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Bellevue, Washington, 98004

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Tacoma, Washington

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Tacoma, Washington, 98405

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

International Sites

Prometheus Biosciences Selected Site, Old Toongabbie, New South Wales, Australia

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Old Toongabbie, New South Wales, 2146

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, South Brisbane, Queensland, Australia

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Site

South Brisbane, Queensland, 4101

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Woolloongabba, Queensland, Australia

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Site

Woolloongabba, Queensland, 4102

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Adelaide, South Australia, Australia

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Adelaide, South Australia, 5000

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Leuven, Belgium

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Leuven, , 3000

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Liège, Belgium

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Liège, , 4000

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Halifax, Nova Scotia, Canada

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Site

Halifax, Nova Scotia, B3H 1V7

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, London, Ontario, Canada

Status

Recruiting

Address

Prometheus Biosciences Selected Site

London, Ontario, N6A 5W9

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Brno, Czechia

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Brno, ,

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Slaný, Czechia

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Slaný, , 274 01

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Clichy, France

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Clichy, , 92110

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Nice, France

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Nice, , 06202

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Saint-Priest-en-Jarez, France

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Saint-Priest-en-Jarez, , 42270

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Vandœuvre-lès-Nancy, France

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Vandœuvre-lès-Nancy, , 54511

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Tbilisi, Georgia

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Tbilisi, ,

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Center, Kraków, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Center

Kraków, , 31-501

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Rzeszów, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Rzeszów, , 35-326

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Sopot, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Sopot, , 81-756

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Toruń, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Toruń, , 87-100

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Center, Warsaw, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Center

Warsaw, , 00-635

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Warsaw, Poland

Status

Recruiting

Address

Prometheus Biosciences Selected Site

Warsaw, , 03-580

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Łódź, Poland

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Site

Łódź, , 93-357

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

Prometheus Biosciences Selected Site, Kyiv, Ukraine

Status

Not yet recruiting

Address

Prometheus Biosciences Selected Site

Kyiv, ,

Site Contact

Prometheus Biosciences Call Center

Clinicaltrials@prometheusbiosciences.com

+1-858-332-0362

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