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

Prometheus Biosciences

Status and phase

Active, not recruiting

Phase 2

Conditions

Crohn Disease

Treatments

Device: Companion diagnostic (CDx)

Drug: PRA023 IV

Study type

Interventional

Funder types

Industry

Identifiers

7240-006 (Other Identifier)

2021-000092-37 (EudraCT Number)

PR200-103

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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