Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Palisade Bio
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
* If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure.
Moderately to severely active UC, defined as:
* mMS of 5 to 9 (inclusive), AND
* ES ≥ 2, AND
* RB ≥ 1.
Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed under item b:
a. History of inadequate response or loss of response, or intolerance to at least one prior UC therapy, defined as: i. Oral prednisone ≥ 40 mg/day (or equivalent) or budesonide ≥ 9 mg/day for ≥ 2 weeks.
ii. Corticosteroid dependence: unable to taper \< 10 mg/day prednisone equivalent within 3 months, or relapse within 3 months of discontinuation.
iii. Immunosuppressants: azathioprine ≥ 2 mg/kg/day, 6-mercaptopurine (6-MP) ≥ 1.0 mg/kg/day (or therapeutic 6-thioguanine nucleotide \[6-TGN\] level) for ≥ 12 weeks, or methotrexate ≥ 15 mg/week subcutaneous or intramuscular.
iv. Approved advanced therapies at the approved labelled dose:
1. Anti-tumor necrosis factor (TNF), anti-integrin (vedolizumab), or anti-IL-12/23 for at least 8 weeks; anti-IL 23 for at least 12 weeks.
2. Janus kinase (JAK) inhibitor for at least 8 weeks; sphingosine-1-phosphate receptor (S1PR) modulator for at least 12 weeks.
Note: Demonstration of intolerance requires no minimum dose nor duration of use.
b. Currently receiving one or more of the following treatments: i. Stable oral prednisone at ≤ 20 mg/day (or equivalent) or budesonide ≤ 9 mg for ≥ 2 weeks prior to randomization.
ii. Stable dose of thiopurine (azathioprine or 6-MP) for ≥ 4 weeks prior to randomization, and have started the treatment ≥ 12 weeks prior to randomization.
iii. Stable dose of oral aminosalicylates for ≥ 2 weeks prior to randomization.
You may not be if
UC limited to rectum (\< 15 cm from anal verge).
Any prior history of suicidal behavior (actual, interrupted, aborted attempt, or preparatory acts).
Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation type 4 or 5, or any active suicidal ideation with some intent to act.
Severe depression at Screening based on a validated scale threshold (e.g., Patient Health Questionnaire-9 \[PHQ-9\] ≥ 20, or PHQ-9 item 9 \> 0) at Screening.
Failure or intolerance of \> 3 classes of approved advanced therapies or \> 4 approved individual advanced therapies.
