Clinical trial NCT05013905: A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Crohn Disease
Keywords: APOLLO-CD
APOLLO
Crohn's Disease
Lead sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse Events
timeFrame: Week 12
measure: Serious Adverse Events
timeFrame: Week 12
measure: Adverse Events Leading to Discontinuation
timeFrame: Week 12
measure: Endoscopic Improvement
timeFrame: Week 12
Secondary outcomes:
measure: Clinical Remission
timeFrame: Week 12
measure: Endoscopic and Clinical Improvement
timeFrame: Week 12
measure: Number of Participants Achieving a Composite Response
timeFrame: Week 12
measure: Normalization of C-reactive Protein
timeFrame: Week 12
measure: Normalization of Fecal Calprotectin
timeFrame: Week 12
measure: Clinical Response
timeFrame: Week 12
measure: Two Component Patient-reported Outcome (PRO-2) Remission
timeFrame: Week 12
measure: Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
timeFrame: Baseline and Week 12
measure: Serum Concentration of PRA023 (MK-7240)
timeFrame: Week 12
measure: Number of Participants Positive for Anti-drug Antibody (ADA)
timeFrame: Up to approximately 12 weeks
measure: Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
timeFrame: Up to approximately 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Prometheus Biosciences Selected Site
state: California
city: Los Angeles
country: United States
facility: Prometheus Biosciences Selected Site
state: California
city: Liberty
country: United States
facility: Prometheus Biosciences Selected Site
state: Kansas
city: Chesterfield
country: United States
facility: Prometheus Biosciences Selected Site
state: Michigan
city: Ypsilanti
country: United States
facility: Prometheus Biosciences Selected Site
state: Michigan
city: Saint Louis
country: United States
facility: Prometheus Biosciences Selected Site
state: Missouri
city: Lebanon
country: United States
facility: Prometheus Biosciences Selected Site
state: New Hampshire
city: New York
country: United States
facility: Prometheus Biosciences Selected Site
state: New York
city: Garland
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Lubbock
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Lubbock
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: San Antonio
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Southlake
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Tyler
country: United States
facility: Prometheus Biosciences Selected Site
state: Texas
city: Bellevue
country: United States
facility: Prometheus Biosciences Selected Site
state: Washington
city: Tacoma
country: United States
facility: Prometheus Biosciences Selected Site
state: Washington
city: Bankstown
country: Australia
facility: Prometheus Biosciences Selected Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Prometheus Biosciences Selected Site
state: Queensland
city: Adelaide
country: Australia
facility: Prometheus Biosciences Selected Site
state: South Australia
city: Leuven
country: Belgium
facility: Prometheus Biosciences Selected Site
city: Liège
country: Belgium
facility: Prometheus Biosciences Selected Site
city: London
country: Canada
facility: Prometheus Biosciences Selected Site
state: Ontario
city: Brno
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Slaný
country: Czechia
facility: Prometheus Biosciences Selected Site
city: Clichy
country: France
facility: Prometheus Biosciences Selected Site
city: Nice
country: France
facility: Prometheus Biosciences Selected Site
city: Saint-Priest-en-Jarez
country: France
facility: Prometheus Biosciences Selected Site
city: Vandœuvre-lès-Nancy
country: France
facility: Prometheus Biosciences Selected Site
city: Tbilisi
country: Georgia
facility: Prometheus Biosciences Selected Site
city: Kraków
country: Poland
facility: Prometheus Biosciences Selected Center
city: Rzeszów
country: Poland
facility: Prometheus Biosciences Selected Site
city: Sopot
country: Poland
facility: Prometheus Biosciences Selected Site
city: Toruń
country: Poland
facility: Prometheus Biosciences Selected Site
city: Warsaw
country: Poland
facility: Prometheus Biosciences Selected Center
city: Warsaw
country: Poland
facility: Prometheus Biosciences Selected Site
city: Warsaw
country: Poland
facility: Prometheus Biosciences Selected Center
city: Wrocław
country: Poland
facility: Prometheus Biosciences Selected Site
Study officials:
affiliation: Clinicaltrials Call Center
name: Prometheus Biosciences
role: STUDY_DIRECTOR
References: