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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05316220

Collaborator

(none)

Enrollment

Locations

Arms

27.1

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis (UC)	Drug: Mesalamine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 13, 2022

Anticipated Primary Completion Date :

Sep 14, 2024

Anticipated Study Completion Date :

Sep 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesalamine Dose A Participants will receive mesalamine Dose A twice daily for 26 weeks.	Drug: Mesalamine Oral Capsules Other Names: Delzicol
Experimental: Mesalamine Dose B Participants will receive mesalamine Dose B twice daily for 26 weeks.	Drug: Mesalamine Oral Capsules Other Names: Delzicol Drug: Placebo Oral Capsule

Arm

Intervention/Treatment

Experimental: Mesalamine Dose A

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

Drug: Mesalamine

Oral Capsules

Other Names:

Delzicol

Experimental: Mesalamine Dose B

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

Drug: Mesalamine

Oral Capsules

Other Names:

Delzicol

Drug: Placebo

Oral Capsule

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens National /ID# 243379	Washington	District of Columbia	United States	20010-2916
2	Angel Kids Pediatrics /ID# 244874	Jacksonville	Florida	United States	32225-3131
3	Treken Primary Care /ID# 241302	Atlanta	Georgia	United States	30315
4	Eagle Clinical Research /ID# 242045	Chicago	Illinois	United States	60621
5	Virgo Carter Pediatrics /ID# 241556	Silver Spring	Maryland	United States	20910
6	UH Cleveland Medical Center /ID# 243375	Cleveland	Ohio	United States	44106
7	Children's Hospital Oklahoma /ID# 242614	Oklahoma City	Oklahoma	United States	73104
8	Carilion Medical Center /ID# 244398	Roanoke	Virginia	United States	24014
9	San Juan Bautista School of Medicine /ID# 243377	Caguas		Puerto Rico	726
10	Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595	San Juan		Puerto Rico	912