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
Last Update Posted : December 19, 2022
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Sponsor:
Prometheus Biosciences, Inc.
Information provided by (Responsible Party):
Prometheus Biosciences, Inc.
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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) |
| Estimated Enrollment : | 50 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 : | July 28, 2021 |
| Actual Primary Completion Date : | September 21, 2022 |
| Estimated Study Completion Date : | August 2023 |
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 :
- Safety and tolerability [ Time Frame: Week 12 ]Incidence of adverse events (AE), serious adverse events (SAE), AE leading to discontinuation
- Endoscopic improvement [ Time Frame: Week 12 ]Proportion of participants achieving induction of endoscopic improvement
Secondary Outcome Measures :
- Induction of clinical remission [ Time Frame: Week 12 ]Proportion of participants achieving clinical remission
- Induction of endoscopic and clinical improvement [ Time Frame: Week 12 ]Proportion of participants with endoscopic and clinical improvement
- Biomarker and clinical improvement [ Time Frame: Week 12 ]Proportion of participants with biomarker and clinical improvement
- Normalization of C-reactive protein [ Time Frame: Week 12 ]Proportion of participants with normalization of C-reactive protein
- Normalization of fecal calprotectin [ Time Frame: Week 12 ]Proportion of participants with normalization of fecal calprotectin
- Clinical improvement [ Time Frame: Week 12 ]Proportion of participants with clinical improvement
- Two component patient-reported outcome (PRO-2) remission [ Time Frame: Week 12 ]Proportion of participants achieving PRO-2 remission
- Simple endoscopy score for Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]Assessment of change in SES-CD
Other Outcome Measures:
- Endoscopic Improvement and clinical remission by companion diagnostic (CDx) status [ Time Frame: Week 12 ]Proportion of CDx+ participants achieving primary and key secondary efficacy outcome measures
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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.
Investigators
| Study Director: | Prometheus Biosciences | Clinicaltrials Call Center |
| Responsible Party: | Prometheus Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT05013905 |
| Other Study ID Numbers: |
PR200-103 2021-000092-37 ( EudraCT Number ) |
| First Posted: | August 19, 2021 Key Record Dates |
| Last Update Posted: | December 19, 2022 |
| Last Verified: | December 2022 |
| 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.:
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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 |