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Ulcerative Colitis (UC)Phase 3NCT05316220

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

A Phase 3 study testing Mesalamine in people with Ulcerative Colitis (UC), run by AbbVie at 10 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Mesalamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
10 sitesin 2 countries
Study dates
15 Sep 2025to 19 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States8 sites

  • Treken Primary Care /ID# 241302

    Atlanta, Georgia, 30315

  • Eagle Clinical Research /ID# 242045

    Chicago, Illinois, 60621

  • UH Cleveland Medical Center /ID# 243375

    Cleveland, Ohio, 44106

  • Angel Kids Pediatrics /ID# 244874

    Jacksonville, Florida, 32225-3131

  • Children's Hospital Oklahoma /ID# 242614

    Oklahoma City, Oklahoma, 73104

  • Carilion Medical Center /ID# 244398

    Roanoke, Virginia, 24014

  • Virgo Carter Pediatrics /ID# 241556

    Silver Spring, Maryland, 20910

  • Childrens National /ID# 243379

    Washington D.C., District of Columbia, 20010-2916

Other trials in United States

Puerto Rico2 sites

  • San Juan Bautista School of Medicine /ID# 243377

    Caguas, 726

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

    San Juan, 912

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
Mesalamine, Placebo
Keywords
Ulcerative Colitis (UC), Mesalamine, Delzicol, AGN-226474
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MesalamineDrug

    Also called Delzicol

    Oral Capsules

  • PlaceboDrug

    Oral Capsule

Study groups in NCT05316220
Study groupRoleWhat they receive
Mesalamine Dose AExperimentalParticipants will receive mesalamine Dose A twice daily for 26 weeks.
Receives: Drug: Mesalamine
Mesalamine Dose BExperimentalParticipants will receive mesalamine Dose B twice daily for 26 weeks.
Receives: Drug: Mesalamine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 26

Secondary outcomes (2)

  1. 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.

    Measured: Week 26

  2. 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.

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion19 Jul 2026 (estimated)
  4. Study completion19 Jul 2026 (estimated)

Why it stopped: strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316220
Sponsor's protocol ID
M21-517
Status last verified
Aug 2025
First submitted
31 Mar 2022
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesalamine in people with Ulcerative Colitis (UC), run by AbbVie at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS) (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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