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TEV-48574 for Ulcerative Colitis and Crohn's Disease (RELIEVE UCCD Trial)
RELIEVE UCCD Trial Summary
This trial will test the effectiveness and best dose of a drug to treat Ulcerative Colitis or Crohn's Disease, assessing safety and immunogenicity too.
RELIEVE UCCD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RELIEVE UCCD Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with a specific type of colitis.I have a serious colon condition that might prevent a safe endoscopy.I expect to need major surgery during the study.I have had an organ transplant.I have had a serious infection like CMV, PCP, or aspergillosis.I understand the study and its risks.I have been diagnosed with Ulcerative Colitis or Crohn's Disease for at least 3 months.I have a history of or currently have a serious infection.I haven't had cancer in the last 5 years, except for certain skin cancers, cervical in situ carcinoma treated over a year ago, or successfully removed papillary thyroid cancer.I have tested positive for Hepatitis B, Hepatitis C, or HIV.I can communicate well and follow the study's requirements.I am a man who will use condoms during the study and for 50 days after if my partner can have children.I haven't had a serious infection or positive stool test in the last 4 weeks.I cannot become pregnant due to surgery or being postmenopausal for over a year.
- Group 1: Placebo UC
- Group 2: TEV-48574 Dose A (UC)
- Group 3: Placebo CD
- Group 4: TEV-48574 Dose B (UC)
- Group 5: TEV-48574 Dose B (CD)
- Group 6: TEV-48574 Dose A (CD)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA cleared TEV-48574 Dose C (UC) for medical use?
"Given that this is a Phase 2 trial - meaning there is only some data supporting safety and none for efficacy - our team at Power estimated the safety of TEV-48574 Dose C (UC) to be a 2."
How many participants are being asked to join this research project?
"That is correct. If you refer to the information available on clinicaltrials.gov, you will see that this particular trial is looking for new participants. The original posting was on 8/29/2022 and it has been updated as recently as 10/31/2022. They are hoping to have 280 people participate from 1 site."
Might I be able to join this clinical trial?
"This medical trial is currently enrolling 280 individuals that have been diagnosed with colitis or ulcerative between the ages of 18 and 75. To be eligible, applicants must meet the following requirements: A diagnosis of Ulcerative colitis (UC) or Crohn's disease (CD) for a minimum of 3 months, The ability to understand the nature of the study and any potential risks associated with participating, The capacity to communicate satisfactorily with the investigator and comply with study demands, Women who are unable to bear children who are either surgically sterile or in menopause, Male participants with women of childbearing potential as partners must"
Are recruitment efforts for this research study ongoing at present?
"Yes, the trial is still looking for participants and was last updated on October 31st, 2020. Originally, the study was posted on August 29th, 2020."
Will this research be enrolling octogenarians?
"This study is recruiting patients that fit the following age criteria: 18 years or older, and 75 years or younger."
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