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PL-8177 for Ulcerative Colitis (PL8177-205 Trial)
PL8177-205 Trial Summary
This trial is testing a new drug for ulcerative colitis. Patients will take it once a day for 8 weeks, then there will be a 4-week follow-up period.
PL8177-205 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PL8177-205 Trial Design
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- I have had cancer within the last 5 years.I agree to use effective birth control during and 30 days after the study.My ulcerative colitis is currently active.I have a history of mitochondrial disorder.I am taking or will take a proton pump inhibitor during the study.I stopped taking thiopurine medication more than 4 weeks ago.I am between 18 and 75 years old.I have an ileostomy or colostomy, or I've had part of my colon removed.I have colon polyps that haven't been removed.I am taking 5-ASA with a specific dose and duration before my screening test.I have a serious health condition affecting my nerves, mind, eyes, lungs, heart, stomach (not including ulcerative colitis), liver, kidneys, hormones, or another major system.I have or had Crohn's disease or similar conditions.I am not taking any medications that are not allowed in the study.I have not had a menstrual period for at least 12 months and my blood test confirms I am postmenopausal.I have previously been treated with PL8177.I stopped taking oral steroids at least 4 weeks before my screening test.My disease extends at least 5 cm up from the start of my anal canal.I understand and can follow the study's requirements and visit schedule.I have not taken any anti-diarrheal medication in the last 48 hours.I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.I have a planned hospital stay or surgery during the study period.My ulcerative colitis diagnosis was confirmed through a scope and tissue tests.I haven't started or changed the dose of any prescription drugs or supplements recently.I have severe colon issues, active stomach ulcers, cervical dysplasia, or primary sclerosing cholangitis.I am between 18 and 75 years old.I have been on a stable dose of 5-ASA medication for at least 3 weeks.I have active ulcerative colitis with significant inflammation.Women who can become pregnant must have a negative pregnancy test before starting the study.I stopped taking 5-ASA at least 3 weeks before my screening endoscopy.
- Group 1: Placebo
- Group 2: PL8177
- 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
What demographic is the most suitable for this scientific endeavor?
"This clinical trial is seeking 28 individuals with ulcerative colitis, aged between 18 and 75 to participate. Eligible candidates must verify that they have a history of UC diagnosis for at least 6 months prior to screening; their modified Mayo Endoscopic Subscore≥2 and fecal calprotectin>250 mcg/g during the sigmoidoscopy; 5-aminosalicylates (5-ASA) usage or discontinuation 4 weeks before the endoscopy; thiopurine discontinuation 4 weeks before the endoscopy as well as corticosteroids stopped ≥4 weeks prior to it; negative"
In which geographical areas can this clinical trial be accessed?
"UPMC Presbyterian in Pittsburgh, Pennsylvania, Medical Professional Clinical Research Center in Miami and Gastro Health - Columbia of New jersey are some of the 20 other locations involved in this clinical trial."
Is participation in this experiment open to individuals aged 25 and above?
"People aged 18 to 75 are the only ones eligible for this particular trial. Separately, there is a total of 70 trials available specifically for minors and 347 clinical studies targeting those over 65 years old."
What is the scope of participation in this research endeavor?
"Palatin Technologies, Inc. will be administering this trial from two locations: UPMC Presbyterian in Pittsburgh and Medical Professional Clinical Research Centre in Miami; 28 patients with the correct prerequisites must be recruited for the study to proceed."
Has the FDA sanctioned PL8177 for patient usage?
"The safety of PL8177 was assessed as a two since this is a Phase 2 trial, thus reflecting the fact that while there is evidence of it being safe, none has been established for its efficacy."
Are there any vacancies for participants in this experiment?
"Affirmative, the trial described on clinicaltrials.gov has been actively enrolling since August 15th 2022 and was last updated in November 19th 2022. The research project is currently seeking 28 individuals to participate across 20 clinics."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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