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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05013905
Recruitment Status : Active, not recruiting
First Posted : August 19, 2021
Last Update Posted : December 19, 2022
Information provided by (Responsible Party):
Prometheus Biosciences, Inc.

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

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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 related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: PRA023
Participants to receive PRA023 administered by intravenous (IV) infusion.
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 :
  1. Safety and tolerability [ Time Frame: Week 12 ]
    Incidence of adverse events (AE), serious adverse events (SAE), AE leading to discontinuation

  2. Endoscopic improvement [ Time Frame: Week 12 ]
    Proportion of participants achieving induction of endoscopic improvement

Secondary Outcome Measures :
  1. Induction of clinical remission [ Time Frame: Week 12 ]
    Proportion of participants achieving clinical remission

  2. Induction of endoscopic and clinical improvement [ Time Frame: Week 12 ]
    Proportion of participants with endoscopic and clinical improvement

  3. Biomarker and clinical improvement [ Time Frame: Week 12 ]
    Proportion of participants with biomarker and clinical improvement

  4. Normalization of C-reactive protein [ Time Frame: Week 12 ]
    Proportion of participants with normalization of C-reactive protein

  5. Normalization of fecal calprotectin [ Time Frame: Week 12 ]
    Proportion of participants with normalization of fecal calprotectin

  6. Clinical improvement [ Time Frame: Week 12 ]
    Proportion of participants with clinical improvement

  7. Two component patient-reported outcome (PRO-2) remission [ Time Frame: Week 12 ]
    Proportion of participants achieving PRO-2 remission

  8. Simple endoscopy score for Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]
    Assessment of change in SES-CD

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Sponsors and Collaborators
Prometheus Biosciences, Inc.
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Study Director: Prometheus Biosciences Clinicaltrials Call Center
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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

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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.:
Crohn's Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases