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

NCT05466890 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PL8177-205
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 14

Brief Summary

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).

Conditions

Ulcerative Colitis; Ulcerative Colitis Acute; Ulcerative; Ulcerative Colitis Flare

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of PL8177 compared to placebo in patients with active UC.

  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.

  Baseline through Study Completion (Week 12).

• 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.

  Efficacy will be determined through the use of the Mayo Endoscopic Subscore.

  Time Frame: Mayo Endoscopic Subscore will be evaluated at Week 8.

Other Outcomes (14)

• Summarize and evaluate the efficacy of PL8177 compared to placebo on histologic-endoscopic mucosal improvement

  Baseline through Week 8

• Summarize and evaluate the efficacy of PL8177 compared to placebo on endoscopic remission

  Baseline through Week 8

• Summarize and evaluate the efficacy of PL8177 compared to placebo on histologic remission

  Baseline through Week 8

Study Arms (2)

PL8177

EXPERIMENTAL

PL8177 will be given orally and daily from baseline until end of study.

Drug: PL8177

Placebo

PLACEBO COMPARATOR

Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.

Drug: PL8177 Placebo

Interventions

PL8177 Placebo DRUG

Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.

Also known as: Placebo

Placebo

PL8177 DRUG

Approximately 3/4 of randomized patients will receive active PL8177.

Also known as: Active study medication

PL8177

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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).

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (14)

Del Sol Research Management, LLC

Tucson, Arizona, 85712, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

Valiance Clinical Research

Tarzana, California, 91356, United States

Location

Advanced Research LLC

Coral Springs, Florida, 33067, United States

Location

IHS Health Research/Gastro Health

Kissimmee, Florida, 34741, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

Kansas Gastroenterology

Wichita, Kansas, 67226, United States

Location

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Allied Health Clinical Research Organization, LLC - Englewood

Englewood, New Jersey, 07631, United States

Location

Allied Digestive Health LLC

Freehold, New Jersey, 07728, United States

Location

Allied Health Clinical Research Organization, LLC

Jackson, New Jersey, 08527, United States

Location

Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease

New York, New York, 10065, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Ulcer

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Jordan, VP Clinical Operations

  Telephone: 609-598-1786; Email: rjordan@palatin.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All trial participants, investigator sites, and Sponsor are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A non-stratified permuted block randomization scheme will be used to randomize the patients in a 3:1 ratio (PL8177: placebo).

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 20, 2022
• Study Start: September 15, 2022
• Primary Completion: February 10, 2025
• Study Completion: March 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)