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Monoclonal Antibodies

Ontamalimab for Ulcerative Colitis

Phase 3
Waitlist Available
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial is testing a new drug for safety and tolerability in people with moderate to severe UC or CD.

Who is the study for?
This trial is for people with moderate to severe Ulcerative Colitis or Crohn's Disease who have previously responded well to Ontamalimab treatment in earlier studies. They must understand and agree to the study rules, be on a stable dose of current treatments, and not plan any major surgeries. Pregnant women, those planning pregnancy, or individuals unable to follow contraception guidelines cannot participate.Check my eligibility
What is being tested?
The AIDA trial is testing the long-term safety and tolerability of two doses (25 mg and 75 mg) of Ontamalimab in patients with Ulcerative Colitis or Crohn's Disease who've had positive responses in prior related trials.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones may include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, potential infections due to immune system suppression by Ontamalimab, headaches, fatigue, and possible allergic reactions.

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event
Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event
+2 more
Secondary outcome measures
Number of Participants with Crohn's Disease with Treatment Response Over Time
Number of Participants with Ulcerative Colitis with Treatment Response Over Time

Trial Design

2Treatment groups
Experimental Treatment
Group I: 75 mg OntamalimabExperimental Treatment1 Intervention
Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
Group II: 25 mg OntamalimabExperimental Treatment1 Intervention
Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.

Find a Location

Who is running the clinical trial?

ShireLead Sponsor
456 Previous Clinical Trials
96,735 Total Patients Enrolled
Study DirectorStudy DirectorShire
1,207 Previous Clinical Trials
489,123 Total Patients Enrolled

Media Library

Ontamalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03283085 — Phase 3
Crohn's Disease Research Study Groups: 75 mg Ontamalimab, 25 mg Ontamalimab
Crohn's Disease Clinical Trial 2023: Ontamalimab Highlights & Side Effects. Trial Name: NCT03283085 — Phase 3
Ontamalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03283085 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list the age requirements for this research program?

"This research study requires that all participants must between the ages of 16 to 80 years old."

Answered by AI

Are there many sites running this study in the city?

"In addition to 38 other sites, this clinical trial is taking place at Baylor College of Medicine in Houston, Texas, Winchester Gastroenterology Associates in Winchester, Virginia, and Gastro One in Germantown, Tennessee."

Answered by AI

At what dosage is Ontamalimab federally permitted?

"There is some efficacy data available from Phase 3 clinical trials, as well as multiple rounds of safety data, so our team at Power has rated the safety of 25 mg Ontamalimab to be a 3."

Answered by AI

Could you explain who would be a good candidate for this treatment?

"557 patients that suffer from ulcerative colitis and are between 16-80 years old qualify for this study."

Answered by AI

To your knowledge, has something like this been done before?

"The only ongoing study for 25 mg Ontamalimab is being conducted in 200 cities across 38 countries. The first clinical trial for this dosage of the drug was completed in 2018 and involved 557 participants. The study reached the Phase 3 drug approval stage and was sponsored by Shire. Since 2018, two more studies have been completed."

Answered by AI

Can you please tell me what additional research has been conducted on 25 mg Ontamalimab?

"In 2018, the efficacy of 25mgOntamalimab was first studied at Jikei University Hospital. Since then, there have been 2 completed studies with 1 more ongoing. The latter is recruiting patients from multiple locations, with a notable concentration in Houston, Texas."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Advanced Clinical Research Network
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
2018. "A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03283085.
All > Crohns Disease > Colitis
~79 spots leftby Apr 2025
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