A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease (APOLLO-CD)
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| ClinicalTrials.gov Identifier: NCT05013905 |
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Recruitment Status :
Active, not recruiting
First Posted : August 19, 2021
Results First Posted : November 1, 2023
Last Update Posted : February 28, 2024
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Sponsor:
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Information provided by (Responsible Party):
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn Disease | Drug: PRA023 IV Device: Companion diagnostic (CDx) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 1, 2021 |
| Actual Primary Completion Date : | September 23, 2022 |
| Estimated Study Completion Date : | January 30, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: PRA023
Participants to receive PRA023 administered by intravenous (IV) infusion.
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Drug: PRA023 IV
PRA023 administered at timepoints as directed by the protocol
Other Name: PRA023 administered by IV Infusion Device: Companion diagnostic (CDx) CDx+ or CDx- |
Primary Outcome Measures :
- Adverse Events [ Time Frame: Week 12 ]Number of participants who experienced treatment-emergent adverse events (AEs)
- Serious Adverse Events [ Time Frame: Week 12 ]Number of participants who experienced serious adverse events (SAEs)
- Adverse Events Leading to Discontinuation [ Time Frame: Week 12 ]Number of participants who experienced AEs leading to discontinuation
- Endoscopic Improvement [ Time Frame: Week 12 ]Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] ≥ 50% from Baseline)
Secondary Outcome Measures :
- Clinical Remission [ Time Frame: Week 12 ]Number of participants achieving clinical remission, as defined by Crohn's disease activity index [CDAI] score < 150
- Endoscopic and Clinical Improvement [ Time Frame: Week 12 ]Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI<150
- Number of Participants Achieving a Composite Response [ Time Frame: Week 12 ]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.
- Normalization of C-reactive Protein [ Time Frame: Week 12 ]Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12
- Normalization of Fecal Calprotectin [ Time Frame: Week 12 ]Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12
- Clinical Response [ Time Frame: Week 12 ]Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150.
- Two Component Patient-reported Outcome (PRO-2) Remission [ Time Frame: Week 12 ]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.
- Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) [ Time Frame: Baseline and Week 12 ]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.
- Serum Concentration of PRA023 (MK-7240) [ Time Frame: Week 12 ]Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12.
- Number of Participants Positive for Anti-drug Antibody (ADA) [ Time Frame: Up to approximately 12 weeks ]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.
- Number of Participants With Positive Neutralizing Anti-Bodies (NAB) [ Time Frame: Up to approximately 12 weeks ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013905
Locations
Show 37 study locations
Sponsors and Collaborators
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Investigators
| Study Director: | Prometheus Biosciences | Clinicaltrials Call Center |
Study Documents (Full-Text)
Documents provided by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA):
Documents provided by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA):
Study Protocol [PDF] June 28, 2022
Statistical Analysis Plan [PDF] April 19, 2022
Additional Information:
| Responsible Party: | Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
| ClinicalTrials.gov Identifier: | NCT05013905 |
| Other Study ID Numbers: |
PR200-103 7240-006 ( Other Identifier: Merck ) 2021-000092-37 ( EudraCT Number ) |
| First Posted: | August 19, 2021 Key Record Dates |
| Results First Posted: | November 1, 2023 |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA):
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APOLLO-CD APOLLO Crohn's Disease |
Additional relevant MeSH terms:
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |