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

Phase 3

Not yet recruiting

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Mesalamine Dose B	Placebo	Participants will receive mesalamine Dose B twice daily for 26 weeks.
Mesalamine Dose A	Mesalamine	Participants will receive mesalamine Dose A twice daily for 26 weeks.
Mesalamine Dose B	Mesalamine	Participants will receive mesalamine Dose B twice daily for 26 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)	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.

Secondary Outcome Measures

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

Locations (10): Angel Kids Pediatrics /ID# 244874
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Jacksonville, Florida, United States
UH Cleveland Medical Center /ID# 243375
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Cleveland, Ohio, United States
Treken Primary Care /ID# 241302
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Atlanta, Georgia, United States
Eagle Clinical Research /ID# 242045
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Chicago, Illinois, United States
Childrens National /ID# 243379
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Washington, District of Columbia, United States
Children's Hospital Oklahoma /ID# 242614
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Oklahoma City, Oklahoma, United States
Virgo Carter Pediatrics /ID# 241556
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Silver Spring, Maryland, United States
Carilion Medical Center /ID# 244398
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Roanoke, Virginia, United States
Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595
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San Juan, Puerto Rico
San Juan Bautista School of Medicine /ID# 243377
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Caguas, Puerto Rico