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About
The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).
Full description
This study will have potential subjects participating for approximately 4 months: Subjects will be screened to assess their eligibility within 28 days prior to the first dose administration; Day 1 will be eligibility confirmation and in-clinic dosing; additional visits to occur at Weeks 2, 4, 8 and 12. Routine laboratory tests, vital signs and ECG will be measured as well as blood, stool and tissue samples obtained for biomarker and PK studies. Endoscopy is required at screening visit and week 8 visit. Patients will also be given an electronic diary to enter on a daily basis for the duration of their participation. Additional patient questionnaires will be done at clinic visits. Optional genomics testing will also be completed for this study to help look at genes and their effect on inflammation.
Enrollment
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Volunteers
Inclusion criteria
Note: If no complete colonoscopy (adequate in quality to assess for dysplasia and colorectal polyps) has been performed and documented (with reports) within the past 1 year as recommended by local and national guidelines depending on Colorectal cancer risk factors in the specified subject, a full colonoscopy should be performed at screening. If such results are available within one year, a flexible sigmoidoscopy with examination up to the splenic flexure will be used for screening.
Has active UC defined as a MES ≥2 during screening sigmoidoscopy.
Has evidence of endoscopic disease extending to at least 5 cm proximal to the anal verge.
If currently receiving 5-ASA, the duration and dose prior to the screening endoscopy must be as specified below, and a stable dose must be maintained throughout the double-blind trial: 5-aminosalicylates (5-ASA) (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) for ≥4 weeks with the dose stable for ≥3 weeks prior to the screening endoscopy.
If recently has received any of the following treatments, they must have discontinued as specified below:
Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to first dose of study drug.
Male and female subjects of childbearing potential must agree to use 1 highly effective form of birth control during study participation and for 30 days after the last dose of study drug, unless the subject or his/her partner is surgically sterilized, or the subject agrees to abstain from sexual intercourse.
Highly effective methods of birth control in this study include intrauterine device, hormonal contraceptives (oral, patch, long acting injectable, implant). Note: Oral hormonal contraceptives should be combined estrogen and progesterone. If a progesterone-only oral contraceptive is used, then a second method of birth control should be used as well.
Postmenopausal is defined as lack of menses for ≥12 months prior to screening, confirmed by serum FSH >25 IU at Screening.
Has provided informed consent prior to initiation of any study specific activities/procedures.
Understands and is willing and able to comply with study requirements, including the schedule of events and follow-up visits.
Exclusion criteria
Subjects will be excluded from the study if they meet any of the following criteria at the Screening visit unless otherwise stated:
History of one or more clinically relevant neurologic, psychologic, ophthalmologic, pulmonary, cardiovascular, gastrointestinal (other than the UC), hepatic, renal, endocrine, or other major systemic disease of moderate (or worse) severity, making implementation of the protocol or interpretation of the study difficult. Examples of (but not limited to) conditions to be excluded, are the following:
Uncontrolled hypertension, with systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥90 mmHg.
Uncontrolled hyperlipidemia (even if therapy is ongoing, LDL>200 mg/dl or triglycerides >500 mg/dL).
Known uncontrolled hyperthyroidism or hypothyroidism.
Impaired hepatic function (Aspartate aminotransferase [AST] or Alanine aminotransferase [ALT] values >2.0 times the upper limit of the reference range and/or serum bilirubin >1.5 times the upper limit of the reference range at the screening visit).
Cardiac or pulmonary disease, such as unstable angina or myocardial infarction within the past 12 months, congestive heart failure (CHF) Grade 2, 3, or 4 according to New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, or chronic pulmonary disease requiring oxygen, venous thrombosis.
Stroke or transient ischemic attack (TIA) in the 12 months before screening.
Major depressive illness in the last 3 years; any history of severe psychiatric illness (eg, schizophrenia).
Multiple sclerosis or any other demyelinating disease.
Any of the following laboratory abnormalities:
Has a current bacterial, parasitic, fungal, viral, or mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks prior to the screening visit, and/or oral antibiotics within 2 weeks prior to screening visit and at any time during the screening period.
Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C (HCVAb) at Screening (note: HCV subjects with undetectable viral load will be eligible).
Clinically significant findings on 12-lead ECG such as, but not limited to, 2nd or 3rd degree AV block, prolongation of QRS complex over 120 msec, or QTcF interval ≥450 msec for males and ≥470 msec for females.
Medications of exclusion:
Note: (A daily dose of ASA 81mg, taken for cardio prophylaxis, is considered acceptable to be continued during the study.)
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups, including a placebo group
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Central trial contact
Nazish Huq, Director Clinical Operations
Data sourced from clinicaltrials.gov
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