A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.

Study Overview

• Status: Enrolling by invitation
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: 25mg Eluxadoline; Drug: 100mg Eluxadoline

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Corona, California, United States, 92879
      • Kindred Medical Institute, LLC /ID# 227595
  • Florida
    • Miami, Florida, United States, 33174
      • Florida Research Center, Inc. /ID# 227597
    • Miami, Florida, United States, 33165
      • Valencia Medical & Research Center /ID# 246221
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company /ID# 227594
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc. /ID# 227596

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion Criteria:

• Male or female participants must be 6 to 17 years of age (inclusive)
• Participants must have completed study intervention in their lead-in study

Exclusion Criteria:

• Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
• Participant has known allergies or hypersensitivity to opioids
• Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
• Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
• Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
• Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
• Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction
• Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition.
• Participant is a current regular alcohol drinker and/or binge drinker*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking*), or alcohol addiction, and/or intends to consume alcohol during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label 6-11 years of age: Eluxadoline 50mg; Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.	Drug: 25mg Eluxadoline; Oral Tablets
Experimental: Open Label 12-17 years of age: Eluxadoline 100 mg; Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.	Drug: 25mg Eluxadoline; Oral Tablets; Drug: 100mg Eluxadoline; Oral Tablets
Experimental: Double Blind 6-11 years of age: Eluxadoline 25mg; Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID	Drug: 25mg Eluxadoline; Oral Tablets
Experimental: Double Blind 6-11 years of age: Eluxadoline 50mg; Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID	Drug: 25mg Eluxadoline; Oral Tablets
Experimental: Double Blind 12-17 years of age: Eluxadoline 25mg; Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID	Drug: 25mg Eluxadoline; Oral Tablets
Experimental: Double Blind 12-17 years of age: Eluxadoline 50mg; Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID	Drug: 25mg Eluxadoline; Oral Tablets
Experimental: Double Blind 12-17 years of age: Eluxadoline 100mg; Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID	Drug: 25mg Eluxadoline; Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Adverse Events	52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator	52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator	52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator	52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline	52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline	52 weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Syndrome; Diarrhea; Gastrointestinal Agents; Eluxadoline
• Other Study ID Numbers: 3030-302-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No