Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Prometheus Biosciences, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Clinicaltrials Call Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Belgium, Canada, Czechia, France, Georgia, Poland, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Participants to receive PRA023 administered by intravenous (IV) infusion.
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.