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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04996797
Registration number
NCT04996797
Ethics application status
Date submitted
2/08/2021
Date registered
9/08/2021
Date last updated
16/01/2024
Titles & IDs
Public title
A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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2021-000091-11
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Secondary ID [2]
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PR200-102
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Universal Trial Number (UTN)
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Trial acronym
ARTEMIS-UC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel 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) Testing
Other interventions - Placebo
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.
Treatment: Drugs: PRA023 IV
PRA023 administered by IV infusion
Treatment: Devices: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Other interventions: Placebo
Placebo administered by IV infusion
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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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Intervention code [3]
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Other interventions
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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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Induction of clinical remission
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Assessment method [1]
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Proportion of participants achieving induction of clinical remission
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Safety and tolerability
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Assessment method [2]
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Incidence of AE, SAE, AE leading to discontinuation
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Induction of endoscopic improvement
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Assessment method [1]
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Proportion of participants achieving induction of endoscopic improvement
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Induction of clinical response
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Assessment method [2]
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Proportion of participants achieving induction of clinical response
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Induction of clinical remission in CDx+ participants
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Assessment method [3]
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Proportion of CDx+ participants achieving induction of clinical remission
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Induction of histologic remission
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Assessment method [4]
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Proportion of participants achieving induction of histologic remission
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Induction of histologic-endoscopic mucosal improvement
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Assessment method [5]
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Proportion of participants achieving induction of histologic- endoscopic mucosal improvement
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Induction of endoscopic improvement in CDx+ participants
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Assessment method [6]
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Proportion of CDx+ participants achieving induction of endoscopic improvement
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Induction of clinical response in CDx+ participants
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Assessment method [7]
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Proportion of CDx+ participants achieving induction of clinical response
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Induction of histologic remission in CDx+ participants
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Assessment method [8]
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Proportion of CDx+ participants achieving induction of histologic remission
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Induction of histologic-endoscopic mucosal improvement in CDx+ participants
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Assessment method [9]
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Proportion of CDx+ participants achieving induction of histologic-endoscopic mucosal
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Clinical remission in CDx+ vs. CDx- participants
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Assessment method [10]
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Proportion of of CDx+ vs. CDx- participants achieving clinical remission
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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Induction of mucosal healing
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Assessment method [11]
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Proportion of participants achieving induction of mucosal healing
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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Induction of mucosal healing in CDx+ participants
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Assessment method [12]
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Proportion of CDx+ participants achieving induction of mucosal healing
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Change in IBDQ
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Assessment method [13]
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Change from Baseline in IBDQ through Week 12
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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Change in IBDQ in CDx+ participants
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Assessment method [14]
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Change from Baseline in IBDQ through Week 12 in CDx+ participants
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Timepoint [14]
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Week 12
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Secondary outcome [15]
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Induction of Clinical remission in CDx+ participants per alternative algorithm
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Assessment method [15]
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Proportion of CDx+ participants per alternative algorithm achieving induction of Clinical remission.
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Timepoint [15]
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Week 12
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Eligibility
Key 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.
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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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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
28/07/2021
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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
30/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
178
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Recruitment in Australia
Recruitment state(s)
AdelaideNSW,QLD,SA,VIC
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Recruitment hospital [1]
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Prometheus Biosciences Selected Site - Woodville
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Recruitment hospital [2]
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Prometheus Biosciences Selected Site - Kingswood
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Recruitment hospital [3]
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Prometheus Biosciences Selected Site - Old Toongabbie
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Recruitment hospital [4]
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Prometheus Biosciences Selected Site - South Brisbane
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Recruitment hospital [5]
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Prometheus Biosciences Selected Site - Woolloongabba
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Recruitment hospital [6]
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Prometheus Biosciences Selected Site - Adelaide
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Recruitment hospital [7]
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Prometheus Biosciences Selected Site - Fitzroy
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Recruitment hospital [8]
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Prometheus Biosciences Selected Site - Melbourne
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Recruitment postcode(s) [1]
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- Woodville
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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NSW 2146 - Old Toongabbie
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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VIC 3065 - Fitzroy
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Recruitment postcode(s) [8]
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VIC 3065 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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London
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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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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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04996797
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04996797
Download to PDF