Eluxadoline for Pediatric IBS-D

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety of Eluxadoline, a medication for children and teens with IBS-D (Irritable Bowel Syndrome with Diarrhea). Participants will receive Eluxadoline in varying doses, either openly or in a double-blind setup, meaning some will not know if they are receiving the actual medication or a placebo. It suits those aged 6 to 17 who have completed earlier study phases and regularly experience IBS-D symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eluxadoline is generally well tolerated by adults with irritable bowel syndrome with diarrhea (IBS-D). Studies have found that common side effects include nausea and constipation, but these are usually mild. Importantly, serious side effects rarely occur. Although eluxadoline is approved for adults, its safety and effectiveness in children remain under investigation. This trial aims to gather more information on how well children handle the medication over time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IBS-D?

Eluxadoline is unique because it offers a targeted approach to treating pediatric IBS-D (Irritable Bowel Syndrome with Diarrhea) by acting directly on the gut's opioid receptors to reduce diarrhea and abdominal pain. Unlike traditional treatments for IBS-D, such as loperamide or antispasmodics, which often focus on just slowing gut movement, eluxadoline combines both mu-opioid receptor agonism and delta-opioid receptor antagonism to provide a dual action that helps manage symptoms more effectively. Researchers are excited about eluxadoline because it represents a novel mechanism that could offer improved symptom relief with potentially fewer side effects, making it a promising option for young patients.

What evidence suggests that Eluxadoline might be an effective treatment for pediatric IBS-D?

Research has shown that Eluxadoline helps reduce symptoms of IBS with diarrhea in adults. Studies have found that it firms stools and reduces stomach pain. Many patients reported better control over bowel movements, fewer urgent trips to the bathroom, and an improved overall quality of life. This trial will evaluate Eluxadoline's effectiveness in children with IBS-D, testing various dosages and administration methods for participants aged 6-17. These findings suggest Eluxadoline might also help treat IBS-D in children. ^{2 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1505180

Eluxadoline for Irritable Bowel Syndrome with Diarrhea Eluxadoline is a new therapeutic agent that reduced symptoms of IBS with diarrhea in men and women, with sustained efficacy over 6 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6738625/

Efficacy and Safety of Eluxadoline in Patients With Irritable ... A higher percentage of patients receiving eluxadoline also achieved the secondary endpoints of improvements in stool consistency and abdominal pain compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03339128

NCT03339128 | Study to Explore the Therapeutic Effect of ... The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20446103

Study to Explore the Therapeutic Effect of Eluxadoline in ... The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age, to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S001650851300499X

Eluxadoline Benefits Patients With Irritable Bowel ... Patients receiving eluxadoline at 100 mg and 200 mg also had greater improvements in bowel movement frequency and urgency, global symptoms, quality of life, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5638229/

Eluxadoline in irritable bowel syndrome with diarrhea Safety and tolerability data, pooled from both phase II and III studies, suggest that eluxadoline is generally well tolerated with the most ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/206940s003lbl.pdf

highlights of prescribing information - accessdata.fda.gov treatment of irritable bowel syndrome with diarrhea (IBS-D). (1) ... It is not known if VIBERZI is safe and effective in children. People 65 years old ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04880876

NCT04880876 | A Study Evaluating Oral Eluxadoline ... This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/eluxadoline-oral-route/description/drg-20146792

Eluxadoline (oral route) - Side effects & dosage Eluxadoline is used to treat adults with irritable bowel syndrome with diarrhea (IBS-D). This medicine is available only with your doctor's prescription.