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

NCT05316220 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: M21-517
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis (UC); Mesalamine; Delzicol; AGN-226474

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)

  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 Outcomes (2)

• Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS

  Week 26

• Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS

  Week 26

Study Arms (2)

Mesalamine Dose A

EXPERIMENTAL

Participants will receive mesalamine Dose A twice daily for 26 weeks.

Drug: Mesalamine

Mesalamine Dose B

EXPERIMENTAL

Participants will receive mesalamine Dose B twice daily for 26 weeks.

Drug: Mesalamine; Drug: Placebo

Interventions

Mesalamine DRUG

Oral Capsules

Also known as: Delzicol

Mesalamine Dose A; Mesalamine Dose B

Placebo DRUG

Oral Capsule

Mesalamine Dose B

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Childrens National /ID# 243379

Washington D.C., District of Columbia, 20010-2916, United States

Location

Angel Kids Pediatrics /ID# 244874

Jacksonville, Florida, 32225-3131, United States

Location

Treken Primary Care /ID# 241302

Atlanta, Georgia, 30315, United States

Location

Eagle Clinical Research /ID# 242045

Chicago, Illinois, 60621, United States

Location

Virgo Carter Pediatrics /ID# 241556

Silver Spring, Maryland, 20910, United States

Location

UH Cleveland Medical Center /ID# 243375

Cleveland, Ohio, 44106, United States

Location

Children's Hospital Oklahoma /ID# 242614

Oklahoma City, Oklahoma, 73104, United States

Location

Carilion Medical Center /ID# 244398

Roanoke, Virginia, 24014, United States

Location

San Juan Bautista School of Medicine /ID# 243377

Caguas, 726, Puerto Rico

Location

Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595

San Juan, 912, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 7, 2022
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• 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.

Locations

PR (2); US (8)