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Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC) (PL8177-205)

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ClinicalTrials.gov Identifier: NCT05466890
Recruitment Status : Recruiting
First Posted : July 20, 2022
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies, Inc

Study Description
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Brief Summary:
PL8177 will be given orally once daily to adult ulcerative colitis patients. Patients meeting eligibility criteria will be randomized to receive either PL8177 or placebo (3:1) for a treatment period of 8 weeks followed by a 4-week post-treatment period.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Ulcerative Colitis Acute Ulcerative Ulcerative Colitis Flare Drug: PL8177 Placebo Drug: PL8177 Phase 2

Detailed Description:
The study will include adult males and nonpregnant, nonlactating females with acute UC. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Baseline will occur on Day 1 with visits occuring at Weeks 2, 4, 8 and 12. Dosing will commence on Day 1 and will be given in the clinic the same day, and on Day 4, and Day 8 with at-home daily patient administered dosing in between visits. Routine laboratory tests, vital signs and ECG will be measured as well as biomarker and PK studies. Endoscopy is required at screening and week 8. Patients will also complete a daily electronic diary and patient questionnaires will be done at clinic visits. Optional genomics testing will also be included.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A non-stratified permuted block randomization scheme will be used to randomize the patients in a 3:1 ratio (PL8177: placebo).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All trial participants, Investigator Sites, and Sponsor are blinded. An unblinded independent DMC will review interim study data to make recommendations regarding safety, and whether to increase the sample size, or stop the study due to futility.
Primary Purpose: Treatment
Official Title: Phase 2a, Double-Blind, Randomized Adaptive Design, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Efficacy, PK and Biomarkers With Oral Colon Delivery PL8177 in Adult Subjects With Active Ulcerative Colitis
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : March 17, 2023
Estimated Study Completion Date : June 16, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PL8177
PL8177 will be given orally and daily from Baseline until end of study.
 Drug: PL8177
Approximately 3/4 of randomized patients will receive active 8177
Other Name: active study medication
Placebo Comparator: Placebo
Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177
 Drug: PL8177 Placebo
Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety and tolerability of PL8177 compared to placebo inpatients with active UC. [ Time Frame: Baseline through Study Completion (Week 12). ]
    Adverse events (AEs) will be collected from the time of signing the informed consent form (ICF). All subjects who are randomized will be monitored for AEs until the time they leave the study.

  2. To compare the proportion of subjects achieving Mayo Endoscopic Subscore of ≤ 1 point (0 or 1) between PL8177 and placebo after 8 weeks of treatment. [ Time Frame: Time Frame: Mayo Endoscopic Subscore will be evaluated at Week 8. ]
    Efficacy will be determined through the use of the Mayo Endoscopic Subscore.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 to ≤75 years of age at Screening.
  • Has a history of UC diagnosis at least 6 months prior to screening.
  • Has active UC defined as a modified Mayo Endoscopic Subscore ≥2 during screening sigmoidoscopy, and fecal calprotectin > 250 mcg/g.
  • Has evidence of endoscopic disease extending to at least 5 cm proximal to the anal verge, and minimum involvement of at least 50% of the macroscopically most affected colonic segment, i.e., in case of proctitis at least 50% of the rectum must be involved, in case of left-sided colitis at least 50% of the rectum or the sigmoid colon must be involved, etc. This will be confirmed by a central reader.

  • Demonstrated intolerance, lack of response or inadequate response to aminosalicylates, and naïve to anti-TNF or other biologic, and/or small molecule therapies. 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 patients 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 patient or his/her partner is surgically sterilized, or the patient 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:

  • Any condition, physical finding, laboratory or ECG abnormality, which, in the opinion of the Investigator, poses a safety risk, will prevent the patient from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the patient.
  • 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 bleeding disorder (eg, complement deficiency, hemophilia, history of uncontrolled bleeding).
  • 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>160 mg/dl or triglycerides >500 mg/dL).
  • 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.
  • Serum creatinine >1.5 x the upper limit of normal.
  • 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 patients 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05466890


Contacts
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Contact: Robert Jordan 609-495-2231 rjordan@palatin.com

Locations
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Sponsors and Collaborators
Palatin Technologies, Inc
Investigators
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Study Director: Robert Jordan Palatin
More Information
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Responsible Party: Palatin Technologies, Inc
ClinicalTrials.gov Identifier: NCT05466890    
Other Study ID Numbers: PL8177-205
First Posted: July 20, 2022    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palatin Technologies, Inc:
ulcerative colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases