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Ontamalimab for Ulcerative Colitis
Study Summary
This trial is testing a new drug for safety and tolerability in people with moderate to severe UC or CD.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You may need to undergo a major surgery for ulcerative colitis.You have been recently diagnosed with cancer or your cancer has come back, except for certain types of skin or cervical cancer that have been successfully treated.Participants with ulcerative colitis.You have Crohn's Disease, a type of chronic inflammatory bowel disease.You have ulcerative colitis.You have Crohn's Disease.
- Group 1: 75 mg Ontamalimab
- Group 2: 25 mg Ontamalimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
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