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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
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
Secondary ID [1] 0 0
7240-006
Secondary ID [2] 0 0
PR200-103
Universal Trial Number (UTN)
Trial acronym
APOLLO-CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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-
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Serious Adverse Events
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Adverse Events Leading to Discontinuation
Timepoint [3] 0 0
Week 12
Primary outcome [4] 0 0
Endoscopic Improvement
Timepoint [4] 0 0
Week 12
Secondary outcome [1] 0 0
Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Endoscopic and Clinical Improvement
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Number of Participants Achieving a Composite Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Normalization of C-reactive Protein
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Normalization of Fecal Calprotectin
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Clinical Response
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Two Component Patient-reported Outcome (PRO-2) Remission
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Serum Concentration of PRA023 (MK-7240)
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Number of Participants Positive for Anti-drug Antibody (ADA)
Timepoint [10] 0 0
Up to approximately 12 weeks
Secondary outcome [11] 0 0
Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
Timepoint [11] 0 0
Up to approximately 12 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Prometheus Biosciences Selected Site - Bankstown
Recruitment hospital [2] 0 0
Prometheus Biosciences Selected Site - Woolloongabba
Recruitment hospital [3] 0 0
Prometheus Biosciences Selected Site - Adelaide
Recruitment postcode(s) [1] 0 0
2146 - Bankstown
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Slaný
Country [14] 0 0
France
State/province [14] 0 0
Clichy
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Saint-Priest-en-Jarez
Country [17] 0 0
France
State/province [17] 0 0
Vandœuvre-lès-Nancy
Country [18] 0 0
Georgia
State/province [18] 0 0
Tbilisi
Country [19] 0 0
Poland
State/province [19] 0 0
Kraków
Country [20] 0 0
Poland
State/province [20] 0 0
Rzeszów
Country [21] 0 0
Poland
State/province [21] 0 0
Sopot
Country [22] 0 0
Poland
State/province [22] 0 0
Torun
Country [23] 0 0
Poland
State/province [23] 0 0
Warsaw
Country [24] 0 0
Poland
State/province [24] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prometheus Biosciences
Address 0 0
Clinicaltrials Call Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05013905