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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05013905
Registration number
NCT05013905
Ethics application status
Date submitted
13/08/2021
Date registered
19/08/2021
Titles & IDs
Public title
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
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Scientific title
A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
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Secondary ID [1]
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7240-006
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Secondary ID [2]
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PR200-103
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Universal Trial Number (UTN)
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Trial acronym
APOLLO-CD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRA023 IV
Treatment: Devices - Companion diagnostic (CDx)
Experimental: PRA023 - Participants to receive PRA023 administered by intravenous (IV) infusion.
Treatment: Drugs: PRA023 IV
PRA023 administered at timepoints as directed by the protocol
Treatment: Devices: Companion diagnostic (CDx)
CDx+ or CDx-
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse Events
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Assessment method [1]
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Number of participants who experienced treatment-emergent adverse events (AEs)
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Serious Adverse Events
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Assessment method [2]
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Number of participants who experienced serious adverse events (SAEs)
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Adverse Events Leading to Discontinuation
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Assessment method [3]
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Number of participants who experienced AEs leading to discontinuation
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Timepoint [3]
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Week 12
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Primary outcome [4]
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Endoscopic Improvement
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Assessment method [4]
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Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] = 50% from Baseline)
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Timepoint [4]
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Week 12
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Secondary outcome [1]
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Clinical Remission
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Assessment method [1]
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Number of participants achieving clinical remission, as defined by Crohn's disease activity index \[CDAI\] score \< 150
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Endoscopic and Clinical Improvement
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Assessment method [2]
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Number of participants who achieved a decrease in SES-CD = 50% AND reduction in CDAI = 100 points from Baseline or CDAI\<150
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Number of Participants Achieving a Composite Response
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Assessment method [3]
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Composite response is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI = 100 points from Baseline or CDAI\<150 in subjects with at least one elevated biomarker at baseline.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Normalization of C-reactive Protein
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Assessment method [4]
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Number of participants with normalization of hsCRP (as defined by hsCRP \< 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Normalization of Fecal Calprotectin
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Assessment method [5]
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Number of participants with normalization of fecal calprotectin (fecal calprotectin \< 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Clinical Response
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Assessment method [6]
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Clinical response is defined as either a reduction of either CDAI = 100 points from Baseline or CDAI\<150.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Two Component Patient-reported Outcome (PRO-2) Remission
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Assessment method [7]
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Number of subjects with PRO-2 remission (defined as average daily abdominal pain score = 1 point and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
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Assessment method [8]
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Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Serum Concentration of PRA023 (MK-7240)
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Assessment method [9]
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Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Number of Participants Positive for Anti-drug Antibody (ADA)
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Assessment method [10]
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Blood samples were collected for the determination of anti-PR023 antibodies based on confirmatory assay. The number of participants with confirmed positive anti-PR023 antibodies results at any visit during the study is presented.
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Timepoint [10]
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Up to approximately 12 weeks
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Secondary outcome [11]
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Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
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Assessment method [11]
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Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented.
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Timepoint [11]
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Up to approximately 12 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Prometheus Biosciences Selected Site - Bankstown
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Recruitment hospital [2]
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Prometheus Biosciences Selected Site - Woolloongabba
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Recruitment hospital [3]
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Prometheus Biosciences Selected Site - Adelaide
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Recruitment postcode(s) [1]
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2146 - Bankstown
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
0
0
United States of America
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State/province [3]
0
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Michigan
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Country [4]
0
0
United States of America
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State/province [4]
0
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Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
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New Hampshire
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Country [6]
0
0
United States of America
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State/province [6]
0
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New York
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Country [7]
0
0
United States of America
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State/province [7]
0
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Texas
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Country [8]
0
0
United States of America
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State/province [8]
0
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Washington
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Country [9]
0
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Belgium
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State/province [9]
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Leuven
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Country [10]
0
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Belgium
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State/province [10]
0
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Liège
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Country [11]
0
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Canada
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State/province [11]
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Ontario
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Country [12]
0
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Czechia
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State/province [12]
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Brno
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Country [13]
0
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Czechia
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State/province [13]
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Slaný
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Country [14]
0
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France
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State/province [14]
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Clichy
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Country [15]
0
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France
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State/province [15]
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Nice
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Country [16]
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France
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State/province [16]
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Saint-Priest-en-Jarez
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Country [17]
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France
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State/province [17]
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Vandœuvre-lès-Nancy
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Country [18]
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Georgia
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State/province [18]
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Tbilisi
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Country [19]
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Poland
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State/province [19]
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Kraków
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Country [20]
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Poland
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State/province [20]
0
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Rzeszów
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Country [21]
0
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Poland
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State/province [21]
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Sopot
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Country [22]
0
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Poland
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State/province [22]
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Torun
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Country [23]
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Poland
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State/province [23]
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Warsaw
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Country [24]
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Poland
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State/province [24]
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Wroclaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05013905
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prometheus Biosciences
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Address
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Clinicaltrials Call Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/05/NCT05013905/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/05/NCT05013905/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05013905