Eluxadoline for Pediatric IBS-D

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Opioids

Disqualifiers: No gallbladder, Pancreatitis, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

124 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will check the safety of a medication called Eluxadoline for children with IBS-D who have already taken part in earlier studies. The medication helps to reduce diarrhea and stomach pain by slowing down bowel movements. Eluxadoline is a new drug approved for managing diarrhea predominant irritable bowel syndrome (IBS-D).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug eluxadoline different from other treatments for pediatric IBS-D?

Eluxadoline is unique because it works on three different opioid receptors in the gut, helping to manage diarrhea-predominant irritable bowel syndrome (IBS-D) by reducing symptoms like abdominal pain and stool consistency. Unlike some other treatments, it is taken orally and acts locally in the gastrointestinal tract, with a generally well-tolerated safety profile. ^{1 2 3 4 5}

Research Team

ALLERGAN INC.

Principal Investigator

Allergan

Eligibility Criteria

This trial is for kids aged 6-17 with IBS-D who've finished a previous Phase 2 or Phase 3 study. They can't join if they're pregnant, nursing, plan to be pregnant, have opioid allergies, no gallbladder, biliary or pancreatic issues, severe liver/kidney/blood conditions, alcohol abuse history or intend to drink during the study.

Inclusion Criteria

Participants must have completed study intervention in their lead-in study

I am between 6 and 17 years old.

Exclusion Criteria

I have had pancreatitis or problems with my pancreas structure.

I have a blockage in my bile ducts or issues with the sphincter of Oddi.

You have an ongoing health issue or abnormal results from medical tests that may affect your safety or ability to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Eluxadoline, either open-label or double-blind, based on previous study completion

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Eluxadoline

Trial Overview The trial tests long-term safety of Eluxadoline (100mg and 25mg doses) in children with IBS-D. It's for those who completed earlier phases of the research and now need further evaluation over an extended period.

Participant Groups

Group I: Open Label 6-11 years of age: Eluxadoline 50mg Experimental Treatment 1 Intervention

Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.

Group II: Open Label 12-17 years of age: Eluxadoline 100 mg Experimental Treatment 2 Interventions

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.

Group III: Double Blind 6-11 years of age: Eluxadoline 50mg Experimental Treatment 1 Intervention

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

Group IV: Double Blind 6-11 years of age: Eluxadoline 25mg Experimental Treatment 1 Intervention

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

Group V: Double Blind 12-17 years of age: Eluxadoline 50mg Experimental Treatment 1 Intervention

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

Group VI: Double Blind 12-17 years of age: Eluxadoline 25mg Experimental Treatment 1 Intervention

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

Group VII: Double Blind 12-17 years of age: Eluxadoline 100mg Experimental Treatment 1 Intervention

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

Eluxadoline is already approved in United States for the following indications:

Approved in United States as Viberzi for:

• Irritable Bowel Syndrome with Diarrhea (IBS-D)

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

In phase 3 trials involving patients with diarrhoea-predominant irritable bowel syndrome (IBS-D), eluxadoline significantly improved abdominal pain and stool consistency compared to placebo after 12 and 26 weeks of treatment.

Eluxadoline was generally well tolerated, with constipation being the most common side effect, but no serious complications were reported, making it a safe treatment option for IBS-D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome. Keating, GM.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on eluxadoline for the treatment of patients with irritable bowel syndrome with diarrhea. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. [2018]