Mesalamine for Ulcerative Colitis

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Mesalamine

Disqualifiers: Abnormal exam, ECG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 26 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing mesalamine capsules to see if they are safe and effective for children with Ulcerative Colitis. The medication helps reduce inflammation in the colon. About 80 children will take the capsules regularly for several months, and their health will be monitored through regular check-ups and tests. Mesalamine has been shown to be effective in maintaining remission in ulcerative colitis and is well-tolerated.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of mesalamine or a similar medication before joining the study.

What data supports the effectiveness of the drug Mesalamine for treating ulcerative colitis?

Research shows that Mesalamine is effective in improving symptoms and maintaining remission (a period without symptoms) in patients with ulcerative colitis, as it is the first-line drug for this condition. Studies have demonstrated its efficacy in both once-daily and multiple-daily dosing regimens. ^{1 2 3 4 5}

Is mesalamine safe for humans?

Mesalamine is generally considered safe for treating ulcerative colitis, but it can sometimes cause kidney problems like acute interstitial nephritis (a type of kidney inflammation) and renal failure. Serious side effects are rare, and it is safe during pregnancy, except for certain formulations. ^{2 3 4 6 7}

How is the drug mesalamine unique for treating ulcerative colitis?

Mesalamine is unique for treating ulcerative colitis because it is available in various formulations, including extended-release granules, which can be taken once daily to help maintain remission. This once-daily dosing can be more convenient for patients compared to other treatments that require multiple doses throughout the day. ^{2 3 5 8 9}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for children aged 5 to 17 with Ulcerative Colitis (UC) who have been in remission for at least 30 days and are on a stable dose of mesalamine or equivalent. They must not have significant abnormal results in physical exams, medical history, ECG, blood tests, or urinalysis.

Inclusion Criteria

I have Ulcerative Colitis in remission for 30+ days and am on a stable dose of mesalamine.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral mesalamine capsules twice daily for 26 weeks

26 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Mesalamine
• Placebo

Trial Overview The study is testing the safety and effectiveness of mesalamine capsules compared to a placebo in treating UC in kids. Participants will be randomly assigned to one of two groups and take the treatment twice daily for 26 weeks with follow-up.

Participant Groups

Group I: Mesalamine Dose B Experimental Treatment 2 Interventions

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

Group II: Mesalamine Dose A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

A clinical decision support tool was developed to help identify patients with mild-to-moderate ulcerative colitis who are likely to achieve endoscopic improvement after mesalamine treatment, based on data from a phase 3 trial involving 726 adults.

Key indicators of endoscopic improvement included a 50% reduction in fecal calprotectin, reduced rectal bleeding, and better physician assessments, with the tool showing strong predictive performance (AUC 0.84) for determining patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis. Ma, C., Jeyarajah, J., Guizzetti, L., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Extended-release mesalamine granules for ulcerative colitis. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial. [2016]

4. Australia pubmed.ncbi.nlm.nih.gov

Once-daily versus multiple-daily mesalamine for patients with ulcerative colitis: a meta-analysis. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mesalamine in the Initial Therapy of Ulcerative Colitis. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Acute kidney injury in a girl with ulcerative colitis and cytomegalovirus-induced focal segmental glomerular sclerosis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Direct comparison of two different mesalamine formulations for the maintenance of remission in patients with ulcerative colitis: a double-blind, randomized study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study. [2022]