A study of PRA023 in patients with Crohn's Disease

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000092-37-PL

Enrollment

Registered

2021-08-17

Start date

2021-11-19

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: PRA023 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Not yet assigned CAS Number: 2648504-55-4 Current Sponsor code: PRA023 Other descriptive name: PRA0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female = 18 years of age. - A diagnosis of CD (confirmed by endoscopy + histology). - Moderately to severely active CD as defined by CDAI of = 220 and = 450. - SES-CD score = 6 if ileocolonic or colonic disease; or = 4 if isolated ileal disease only. - Subjects must have had insufficient response and/or intolerance to conventional therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to Day 1 - Diagnosis of ulcerative colitis or indeterminate colitis - CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement - Suspected or diagnosed intra-abdominal or perianal abscess at Screening - Known symptomatic stricture or stenosis not passable in endoscopy (including pediatric colonoscope) - Current stoma or need for colostomy or ileostomy - Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments - Currently receiving total parenteral nutrition - Surgical bowel resection within 3 months before screening - Concomitant PSC - Prior exposure to PRA023 - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness - Legal or mental incapacitation, or inability to understand and comply with the requirements of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the safety and tolerability of PRA023 following 12-weeks of induction therapy 2. To assess the proportion of subjects with endoscopic improvement at Week 12 ;Secondary Objective: To assess the proportion of subjects with: - Clinical remission at Week 12 - Endoscopy and clinical improvement at Week 12 - Biomarker and clinical improvement at Week 12 - Normalization of hsCRP at Week 12, among subjects with elevated concentrations at Baseline - Normalization of fecal calprotectin at Week 12, among subjects with elevated concentrations at Baseline - Clinical improvement at Week 12 - Two-component patient-reported outcome remission at Week 12 To assess: - The change in SES-CD score from Baseline to Week 12 - The PK of PRA023 - The immunogenicity of PRA023;Primary end point(s): 1. Safety and tolerability: the proportion of subjects reporting AEs, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values 2. The proportion of subjects with endoscopic improvement, at Week 12 ;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: 1. To evaluate the safety and tolerability of PRA023 following 12-weeks of induction therapy 2. To assess the proportion of subjects with endoscopic improvement at Week 12 ;Secondary Objective: To assess the proportion of subjects with: - Clinical remission at Week 12 - Endoscopy and clinical improvement at Week 12 - Biomarker and clinical improvement at Week 12 - Normalization of hsCRP at Week 12, among subjects with elevated concentrations at Baseline - Normalization of fecal calprotectin at Week 12, among subjects with elevated concentrations at Baseline - Clinical improvement at Week 12 - Two-component patient-reported outcome remission at Week 12 To assess: - The change in SES-CD score from Baseline to Week 12 - The PK of PRA023 - The immunogenicity of PRA023;Primary end point(s): 1. Safety and tolerability: the proportion of subjects reporting AEs, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values 2. The proportion of subjects with endoscopic improvement, at Week 12 ;Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1. The proportion of subjects in clinical remission at Week 12 2. The proportion of subjects with endoscopic and clinical improvement AND reduction in CDAI from Baseline at Week 12 3. The proportion of subjects with both biomarker and clinical improvement at Week 12 4. The proportion of subjects with normalization of hsCRP, among subjects with elevated concentrations at Baseline, at Week 12 5. The proportion of subjects with normalization of fecal calprotectin (as defined by fecal calprotectin < ULN), among subjects with elevated concentrations at Baseline, at Week 12 6. The proportion of subjects in clinical response at Week 12 7. The proportion of subjects with PRO-2 remission at Week 12 8. Change in SES-CD score at Week 12 from Baseline 9. Descriptive summaries of PK and immunogenicity of PRA023 10. Proportion of subjects developing anti-drug antibody (ADA) and neutralizing antibody (Nab);Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Secondary end point(s): 1. The proportion of subjects in clinical remission at Week 12 2. The proportion of subjects with endoscopic and clinical improvement AND reduction in CDAI from Baseline at Week 12 3. The proportion of subjects with both biomarker and clinical improvement at Week 12 4. The proportion of subjects with normalization of hsCRP, among subjects with elevated concentrations at Baseline, at Week 12 5. The proportion of subjects with normalization of fecal calprotectin (as defined by fecal calprotectin < ULN), among subjects with elevated concentrations at Baseline, at Week 12 6. The proportion of subjects in clinical response at Week 12 7. The proportion of subjects with PRO-2 remission at Week 12 8. Change in SES-CD score at Week 12 from Baseline 9. Descriptive summaries of PK and immunogenicity of PRA023 10. Proportion of subjects developing anti-drug antibody (ADA) and neutralizing antibody (Nab);Timepoint(s) of evaluation of this end point: Week 12

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Countries

Australia, Belgium, Canada, Czechia, Czech Republic, France, Poland, United States

Contacts

Public ContactClinical Operations

Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.

mm@prometheusbiosciences.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026