Mesalamine for Ulcerative Colitis

No longer recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of delayed-release mesalamine capsules for treating children with ulcerative colitis (UC), a disease that causes ongoing inflammation in the colon. Participants will be divided into two groups to receive different doses of mesalamine twice a day for 26 weeks. The study includes regular check-ups, such as medical assessments, blood tests, and questionnaires, to monitor the treatment’s impact and any side effects. Children aged 5 to 17 with UC who are currently stable on mesalamine or a similar medication might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to advancing treatment options for UC.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mesalamine is generally safe for people with ulcerative colitis. One study found that a higher dose of mesalamine is as safe as a lower dose, indicating that more of the drug doesn't necessarily lead to more side effects. Another study confirmed mesalamine's safety for children and teens with mild-to-moderate ulcerative colitis.

In trials involving thousands of patients with inflammatory bowel disease, most of whom had ulcerative colitis, mesalamine was well-tolerated. Common side effects included mild stomach pain, headache, and diarrhea, which were usually not severe.

Although mesalamine is approved for ulcerative colitis, its safety in children under five years old hasn't been fully studied. However, this trial targets children aged five and older. Overall, the evidence suggests that mesalamine is a safe treatment for ulcerative colitis in older children and teens. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about mesalamine for ulcerative colitis because it offers a targeted approach to reducing inflammation in the colon. Unlike some standard treatments that may involve steroids or biologics, mesalamine works directly in the gut to inhibit substances that cause inflammation, potentially leading to fewer systemic side effects. This treatment is administered in two different dosages, Dose A and Dose B, allowing flexibility in managing the condition based on individual patient needs. This focused mechanism and customizable dosing strategy make mesalamine a promising option in the management of ulcerative colitis.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research has shown that mesalamine effectively treats ulcerative colitis (UC), particularly in mild to moderate cases. Studies have found that mesalamine can control symptoms and outperforms a placebo. In one study, 70.9% of patients remained symptom-free after one year of using mesalamine. Doctors often recommend it as the first treatment for UC, and most people tolerate it without serious side effects.

In this trial, participants will receive either Mesalamine Dose A or Mesalamine Dose B to evaluate the effectiveness of different dosages. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449365/

Effectiveness of Mesalamine in Patients With Ulcerative ... Oral 5-ASA induces remission and clinical improvement better than a placebo in active mild-to-moderate UC. Nine patients were treated to improve ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865824007138

MMX mesalamine in ulcerative colitis: Major advantages ... Clinical trials demonstrated a strong efficacy in inducing and maintaining clinical and endoscopic remission in active mild-to-moderate UC. The efficacy is ...

3. irjournal.org irjournal.org/journal/view.php?number=1087

Optimizing 5-aminosalicylate for moderate ulcerative colitis At year 1, the study found that 70.9% of patients who received a daily dose of 2 g 5-ASA maintained remission, while only 58.9% of patients who ...

4. frontiersin.org frontiersin.org/journals/gastroenterology/articles/10.3389/fgstr.2024.1335380/full

The continuing value of mesalazine as first-line therapy for ... The evidence presented demonstrates that mesalazine has a well-supported history as effective and well-tolerated first-line therapy for patients ...

5. acpjournals.org acpjournals.org/doi/10.7326/0003-4819-115-5-350

Oral Mesalamine (Asacol) for Mildly to Moderately Active ... Results: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf

Asacol® (mesalamine) Delayed-Release Tablets ADVERSE REACTIONS: Asacol tablets have been evaluated in 3685 inflammatory bowel disease patients (most patients with ulcerative colitis) in controlled and open ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/mesalamine-oral-route/description/drg-20064708

Mesalamine (oral route) - Side effects & dosage Safety and efficacy have not been established in children younger than 5 years of age and for the prevention of ulcerative colitis in children.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29722441/

Systematic review: safety of mesalazine in ulcerative colitis High-dose mesalazine appears to have similar safety profile as low dose, and is not associated with greater risk of adverse events.

9. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/a/Asacoltabsupposenema.pdf

Asacol Data Sheet Epidemiological data indicate that continued long-term mesalazine maintenance treatment may reduce the risk of colon cancer. Clinical efficacy and safety.

10. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00409-1/fulltext

Safety and efficacy of multimatrix mesalamine in paediatric ... We evaluated the safety and efficacy of low-dose and high-dose once-daily multimatrix mesalamine in children and adolescents with mild-to-moderate UC or those ...