Clinical trial NCT05316220: A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis (UC)
Keywords: Ulcerative Colitis (UC)
Mesalamine
Delzicol
AGN-226474
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS
timeFrame: Week 26
measure: Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS
timeFrame: Week 26
Other outcomes:
Locations:
city: Washington
country: United States
facility: Childrens National /ID# 243379
state: District of Columbia
city: Jacksonville
country: United States
facility: Angel Kids Pediatrics /ID# 244874
state: Florida
city: Atlanta
country: United States
facility: Treken Primary Care /ID# 241302
state: Georgia
city: Chicago
country: United States
facility: Eagle Clinical Research /ID# 242045
state: Illinois
city: Silver Spring
country: United States
facility: Virgo Carter Pediatrics /ID# 241556
state: Maryland
city: Cleveland
country: United States
facility: UH Cleveland Medical Center /ID# 243375
state: Ohio
city: Oklahoma City
country: United States
facility: Children's Hospital Oklahoma /ID# 242614
state: Oklahoma
city: Roanoke
country: United States
facility: Carilion Medical Center /ID# 244398
state: Virginia
city: Caguas
country: Puerto Rico
facility: San Juan Bautista School of Medicine /ID# 243377
city: San Juan
country: Puerto Rico
facility: Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: