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

Last updated: March 27, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Placebo

Mesalamine

Clinical Study ID

NCT05316220
M21-517
  • Ages 5-17
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Abnormal and clinically significant results according to the investigator or designee, onphysical examination, medical history, electrocardiogram (ECG), hematology, clinicalchemistry, or urinalysis.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 15, 2024
Estimated Completion Date:
July 19, 2026

Connect with a study center

  • San Juan Bautista School of Medicine /ID# 243377

    Caguas, 726
    Puerto Rico

    Site Not Available

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

    San Juan, 912
    Puerto Rico

    Site Not Available

  • Childrens National /ID# 243379

    Washington, District of Columbia 20010-2916
    United States

    Site Not Available

  • Angel Kids Pediatrics /ID# 244874

    Jacksonville, Florida 32225-3131
    United States

    Site Not Available

  • Treken Primary Care /ID# 241302

    Atlanta, Georgia 30315
    United States

    Site Not Available

  • Eagle Clinical Research /ID# 242045

    Chicago, Illinois 60621
    United States

    Site Not Available

  • Virgo Carter Pediatrics /ID# 241556

    Silver Spring, Maryland 20910
    United States

    Site Not Available

  • UH Cleveland Medical Center /ID# 243375

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Children's Hospital Oklahoma /ID# 242614

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Carilion Medical Center /ID# 244398

    Roanoke, Virginia 24014
    United States

    Site Not Available

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