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NCT05316220 Clinical Trial

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

Ulcerative Colitis (UC) Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05316220
Other study ID # M21-517
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 15, 2024
Est. completion date July 19, 2026

Study information
Verified date March 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date July 19, 2026
Est. primary completion date July 19, 2026
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mesalamine
Oral Capsules
• Placebo
Oral Capsule

Locations
Country Name City State
Puerto Rico San Juan Bautista School of Medicine /ID# 243377 Caguas
Puerto Rico Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595 San Juan
United States Treken Primary Care /ID# 241302 Atlanta Georgia
United States Eagle Clinical Research /ID# 242045 Chicago Illinois
United States UH Cleveland Medical Center /ID# 243375 Cleveland Ohio
United States Angel Kids Pediatrics /ID# 244874 Jacksonville Florida
United States Children's Hospital Oklahoma /ID# 242614 Oklahoma City Oklahoma
United States Carilion Medical Center /ID# 244398 Roanoke Virginia
United States Virgo Carter Pediatrics /ID# 241556 Silver Spring Maryland
United States Childrens National /ID# 243379 Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS Endoscopic remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1. Week 26
Secondary Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS Symptomatic remission responder based on the mMS s defined as Rectal bleeding subscore = 0 AND Stool frequency subscore <= 1. Week 26
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT05960864 - Chinese Spondyloarthritis Inception Cohort (CESPIC)
Completed NCT02345733 - Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis Phase 4
Terminated NCT02217722 - Use of the Ulcerative Colitis Diet for Induction of Remission N/A
Completed NCT02778464 - Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
Completed NCT01971814 - Early Serum Infliximab Levels in Severe Ulcerative Colitis. Phase 1
Completed NCT03223012 - Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
Active, not recruiting NCT03456206 - Chronic Inflammatory Disease, Lifestyle and Risk of Disease
Completed NCT04254783 - A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Phase 1
Completed NCT03398148 - A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Withdrawn NCT02087878 - A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma
Completed NCT02065622 - Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis Phase 3
Completed NCT03695185 - A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Phase 2
Completed NCT02108821 - Fecal Microbiota Transplantation in Pediatric Patients Phase 1
Terminated NCT03758443 - Efficacy & Safety of TD-1473 in Ulcerative Colitis Phase 2/Phase 3
Completed NCT01364896 - Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Terminated NCT03920254 - TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study Phase 2/Phase 3
Recruiting NCT01277419 - German Spondyloarthritis Inception Cohort
Recruiting NCT05377580 - A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis Phase 2
Recruiting NCT03609905 - Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis Phase 1/Phase 2

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