A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis

March 27, 2024 updated by: AbbVie

A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This study will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.

Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17 years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.

Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico, 726
        • San Juan Bautista School of Medicine /ID# 243377
      • San Juan, Puerto Rico, 912
        • Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2916
        • Childrens National /ID# 243379
    • Florida
      • Jacksonville, Florida, United States, 32225-3131
        • Angel Kids Pediatrics /ID# 244874
    • Georgia
      • Atlanta, Georgia, United States, 30315
        • Treken Primary Care /ID# 241302
        • Contact:
          • Site Coordinator
          • Phone Number: 4043050004
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Eagle Clinical Research /ID# 242045
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Virgo Carter Pediatrics /ID# 241556
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UH Cleveland Medical Center /ID# 243375
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Children's Hospital Oklahoma /ID# 242614
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center /ID# 244398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in remission for at least 30 days prior to the screening visit and are on a stable dose of mesalamine or 5-aminosalicylic acid equivalent.

Exclusion Criteria:

- Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesalamine Dose A
Participants will receive mesalamine Dose A twice daily for 26 weeks.
Drug: Mesalamine
Oral Capsules
Other Names:
  • Delzicol
Experimental: Mesalamine Dose B
Participants will receive mesalamine Dose B twice daily for 26 weeks.
Drug: Placebo
Oral Capsule
Drug: Mesalamine
Oral Capsules
Other Names:
  • Delzicol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)
Time Frame: Week 26
Clinical remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1.
Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS
Time Frame: Week 26
Endoscopic remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1.
Week 26
Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS
Time Frame: Week 26
Symptomatic remission responder based on the mMS s defined as Rectal bleeding subscore = 0 AND Stool frequency subscore <= 1.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2024

Primary Completion (Estimated)

July 19, 2026

Study Completion (Estimated)

July 19, 2026

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis (UC)

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe