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Ulcerative ColitisPhase 2PL8177-205NCT05466890

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

A Phase 2 study testing PL8177 in people with Ulcerative Colitis and Ulcerative Colitis Acute, run by Palatin Technologies, Inc at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PL8177
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
14 sitesUnited States
Study dates
15 Sep 2022to 31 Mar 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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 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:
  • Non-steroidal anti-inflammatory drugs (NSAIDs) daily.
  • Subjects on anti-coagulation therapy within 28 days prior to screening and through Day 56.
  • Note: (A daily dose of ASA 81mg, taken for cardio prophylaxis, is considered acceptable to be continued during the study.)
  • Topical (i.e., enema or suppository) mesalamine or steroid within 14 days prior to screening endoscopy.
  • Azathioprine, 6-mercaptopurine, or methotrexate within the 28 days prior to screening.
  • Any prior use of mycohphenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide
  • Any prior use of biologics: rituximab, efalizumab, anti-integrines (natalizumab, vedolizumab, etrolizumab), TNF antagonists (infliximab, , golimumab, certolizumab pegol), anti-IL-12/23 (ustekinumab, guselkumab, risankizumab, or mirikizumab) ≤ 3 months prior to first dosing or ≤ 5 elimination half-lives prior to first dosing (whichever is shorter).
  • Any prior use of small molecules: JAK inhibitors (tofacitinib, baricitinib, upadacitinib, or other) or S1P receptor modulator (fingolimod, ozanimod, etrasimod) ≤ 3 months prior to first dosing or ≤ 5 elimination half-lives prior to first dosing (whichever is shorter).
  • Use of PPI (proton pump inhibitor) during the study (Should be discontinued 72 hours prior to Day 1).
  • Use of prescription medications started or with a dose adjustment within 4 weeks prior to study screening, or over-the-counter medications or supplements started or with a dose adjustment within 2 weeks prior to study screening. Medications under Inclusion Criterion #5 are not included. Short-term administration of drugs for acute conditions are acceptable.
  • Anti-diarrheal medications are not allowed within 48 hours of screening and throughout the study.
  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device).
  • Subjects with planned hospitalization or surgery during the study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Has previously received PL8177.
  • History of alcohol or drug abuse and/or positive drug test at screening (with exception of marijuana if legal within the state and no drug abuse is noted in the PI's assessment)
  • Positive TB or COVID 19 test. Note: Patients with positive TB results who had active or latent TB in the two years preceding the screening visit and who were treated for TB can participate in study

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Advanced Research LLC

    Coral Springs, Florida, 33067

  • Allied Health Clinical Research Organization, LLC - Englewood

    Englewood, New Jersey, 07631

  • Allied Digestive Health LLC

    Freehold, New Jersey, 07728

  • Allied Health Clinical Research Organization, LLC

    Jackson, New Jersey, 08527

  • IHS Health Research/Gastro Health

    Kissimmee, Florida, 34741

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

  • Gastro Care Institute

    Lancaster, California, 93534

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease

    New York, New York, 10065

  • Orlando Health, Inc.

    Orlando, Florida, 32806

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213-2582

  • Valiance Clinical Research

    Tarzana, California, 91356

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Kansas Gastroenterology

    Wichita, Kansas, 67226

Other trials in United States

About this study

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

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).

Read the detailed 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.

Being tested
PL8177 Placebo, PL8177
Keywords
Ulcerative Colitis
Medical subject headings
Colitis, Ulcerative, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PL8177 PlaceboDrug

    Also called Placebo

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

  • PL8177Drug

    Also called Active study medication

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

Study groups in NCT05466890
Study groupRoleWhat they receive
PL8177ExperimentalPL8177 will be given orally and daily from baseline until end of study.
Receives: Drug: PL8177
PlaceboPlacebo comparatorApproximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.
Receives: Drug: PL8177 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through Study Completion (Week 12).

  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.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start15 Sep 2022
  3. Primary completion10 Feb 2025
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466890
Sponsor's protocol ID
PL8177-205
Acronym
PL8177-205
Status last verified
Feb 2025
First submitted
25 May 2022
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PL8177 in people with Ulcerative Colitis and Ulcerative Colitis Acute, run by Palatin Technologies, Inc at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of PL8177 compared to placebo in patients with active UC. (time frame: Baseline through Study Completion (Week 12).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05466890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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