A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

Crohn Disease Clinical Trial

— APOLLO-CD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05013905
• Other study ID #: PR200-103
• Secondary ID: 7240-0062021-000
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: January 30, 2026

Study information

• Verified date: February 2024
• Source: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: January 30, 2026
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• PRA023 IV
PRA023 administered at timepoints as directed by the protocol

Device:
• Companion diagnostic (CDx)
CDx+ or CDx-

Locations

Country	Name	City	State
Australia	Prometheus Biosciences Selected Site	Adelaide	South Australia
Australia	Prometheus Biosciences Selected Site	Bankstown	New South Wales
Australia	Prometheus Biosciences Selected Site	Woolloongabba	Queensland
Belgium	Prometheus Biosciences Selected Site	Leuven
Belgium	Prometheus Biosciences Selected Site	Liège
Canada	Prometheus Biosciences Selected Site	London	Ontario
Czechia	Prometheus Biosciences Selected Site	Brno
Czechia	Prometheus Biosciences Selected Site	Slaný
France	Prometheus Biosciences Selected Site	Clichy
France	Prometheus Biosciences Selected Site	Nice
France	Prometheus Biosciences Selected Site	Saint-Priest-en-Jarez
France	Prometheus Biosciences Selected Site	Vandœuvre-lès-Nancy
Georgia	Prometheus Biosciences Selected Site	Tbilisi
Poland	Prometheus Biosciences Selected Center	Kraków
Poland	Prometheus Biosciences Selected Site	Rzeszów
Poland	Prometheus Biosciences Selected Site	Sopot
Poland	Prometheus Biosciences Selected Site	Torun
Poland	Prometheus Biosciences Selected Center	Warsaw
Poland	Prometheus Biosciences Selected Center	Warsaw
Poland	Prometheus Biosciences Selected Site	Warsaw
Poland	Prometheus Biosciences Selected Site	Wroclaw
United States	Prometheus Biosciences Selected Site	Bellevue	Washington
United States	Prometheus Biosciences Selected Site	Chesterfield	Michigan
United States	Prometheus Biosciences Selected Site	Garland	Texas
United States	Prometheus Biosciences Selected Site	Lebanon	New Hampshire
United States	Prometheus Biosciences Selected Site	Liberty	Kansas
United States	Prometheus Biosciences Selected Site	Los Angeles	California
United States	Prometheus Biosciences Selected Site	Los Angeles	California
United States	Prometheus Biosciences Selected Site	Lubbock	Texas
United States	Prometheus Biosciences Selected Site	Lubbock	Texas
United States	Prometheus Biosciences Selected Site	New York	New York
United States	Prometheus Biosciences Selected Site	Saint Louis	Missouri
United States	Prometheus Biosciences Selected Site	San Antonio	Texas
United States	Prometheus Biosciences Selected Site	Southlake	Texas
United States	Prometheus Biosciences Selected Site	Tacoma	Washington
United States	Prometheus Biosciences Selected Site	Tyler	Texas
United States	Prometheus Biosciences Selected Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Georgia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants who experienced treatment-emergent adverse events (AEs)	Week 12
Primary	Serious Adverse Events	Number of participants who experienced serious adverse events (SAEs)	Week 12
Primary	Adverse Events Leading to Discontinuation	Number of participants who experienced AEs leading to discontinuation	Week 12
Primary	Endoscopic Improvement	Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] = 50% from Baseline)	Week 12
Secondary	Clinical Remission	Number of participants achieving clinical remission, as defined by Crohn's disease activity index [CDAI] score < 150	Week 12
Secondary	Endoscopic and Clinical Improvement	Number of participants who achieved a decrease in SES-CD = 50% AND reduction in CDAI = 100 points from Baseline or CDAI<150	Week 12
Secondary	Number of Participants Achieving a Composite Response	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.	Week 12
Secondary	Normalization of C-reactive Protein	Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12	Week 12
Secondary	Normalization of Fecal Calprotectin	Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12	Week 12
Secondary	Clinical Response	Clinical response is defined as either a reduction of either CDAI = 100 points from Baseline or CDAI<150.	Week 12
Secondary	Two Component Patient-reported Outcome (PRO-2) Remission	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.	Week 12
Secondary	Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)	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.	Baseline and Week 12
Secondary	Serum Concentration of PRA023 (MK-7240)	Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12.	Week 12
Secondary	Number of Participants Positive for Anti-drug Antibody (ADA)	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.	Up to approximately 12 weeks
Secondary	Number of Participants With Positive Neutralizing Anti-Bodies (NAB)	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.	Up to approximately 12 weeks

External Links

•   Merck Clinical Trials Information