Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative, Ulcerative Colitis Flare

In brief

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).

Key facts

Study ID

NCT05466890

Run by

Palatin Technologies, Inc

People needed

16

Starts

2022-09-15

Expected to finish

2025-03-31

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 to ≤75 years of age at Screening.
• Has a history of UC diagnosis prior to screening; confirmed by endoscopic and histologic evidence in the subject chart. If the historical evidence is not available, then endoscopic and histologic evidence can be confirmed during the screening period.
• 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:
• If 5-ASA has been recently discontinued, it must have been stopped for ≥3 weeks prior to the screening endoscopy.
• If a thiopurine has recently been discontinued, it must have been stopped for ≥4 weeks prior to the screening endoscopy.
• Oral corticosteroids must have been stopped for ≥4 weeks prior to the screening endoscopy.
• 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.

You may not qualify if…

• Subjects will be excluded from the study if they meet any of the following criteria at the Screening visit unless otherwise stated:
• Any condition, physical finding, laboratory or ECG abnormality, which, in the opinion of the Investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.
• Has fulminant colitis, toxic megacolon, microscopic colitis, history of colitis-associated colonic dysplasia, active peptic ulcer disease, cervical dysplasia, or primary sclerosing cholangitis.
• History of Crohn's disease or indeterminate colitis, or the presence or history of a fistula consistent with Crohn's disease.
• Presence of ileostomy or colostomy, or history of prior colon resection.
• Presence of adenomatous colonic polyps that have not been removed.
• Stools positive for C. difficile, enteric pathogens (Salmonella, Shigella, Campylobacter), or ova and parasites within 28 days of screening. Screen failures due to positive C. difficile or other enteric infection can be re-screened after appropriate treatment.
• History of mitochondrial disorder.
• History of primary or secondary immunodeficiency.
• History of cancer within the 5 years prior to screening including solid tumors and hematological malignancies (exception: no approval needed for basal cell and in situ squamous cell carcinomas of the skin that have been adequately treated with no re-occurrence for at least 1 year prior to screening).
• 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:
• Hemoglobin <8.5 g/dl (international system units [SI]: <85 g/L).
• Neutrophils <1500/mm3 (SI: < 1.5 x 109/L).
• White blood cell (WBC) count <3,000/mm3 (SI: < 3.0 x 109/L).
• Platelets <80,000 mm3 (SI: 80 x 109/L).
• International normalized ratio (INR) >1.5.

Where it is running

• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Gastro Care Institute — Lancaster, California, United States
• Valiance Clinical Research — Tarzana, California, United States
• Advanced Research LLC — Coral Springs, Florida, United States
• IHS Health Research/Gastro Health — Kissimmee, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Kansas Gastroenterology — Wichita, Kansas, United States
• Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Allied Health Clinical Research Organization, LLC - Englewood — Englewood, New Jersey, United States
• Allied Digestive Health LLC — Freehold, New Jersey, United States
• Allied Health Clinical Research Organization, LLC — Jackson, New Jersey, United States
• Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease — New York, New York, United States
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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