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

Primary Purpose

Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PL8177 Placebo
PL8177
Sponsored by
Palatin Technologies, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    o 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).
  • 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.

Sites / Locations

  • Del Sol Research Management, LLCRecruiting
  • Gastro Care InstituteRecruiting
  • Valiance Clinical ResearchRecruiting
  • Advanced Research LLCRecruiting
  • IHS Health Research/Gastro HealthRecruiting
  • Medical Professional Clinical Research CenterRecruiting
  • Eminat, LLCRecruiting
  • Orlando Health, Inc.Recruiting
  • Alliance Clinical Research of Tampa, LLCRecruiting
  • Kansas GastroenterologyRecruiting
  • Gastroenterology Clinic of AcadianaRecruiting
  • Delta Research PartnersRecruiting
  • Allied Health Clinical Research Organization, LLC - EnglewoodRecruiting
  • Allied Digestive Health LLCRecruiting
  • Allied Health Clinical Research Organization, LLCRecruiting
  • Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel DiseaseRecruiting
  • UPMC PresbyterianRecruiting
  • Texas Clinical Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PL8177

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of PL8177 compared to placebo inpatients 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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
June 6, 2023
Sponsor
Palatin Technologies, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05466890
Brief Title
Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC)
Acronym
PL8177-205
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palatin Technologies, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative, Ulcerative Colitis Flare
Keywords
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A non-stratified permuted block randomization scheme will be used to randomize the patients in a 3:1 ratio (PL8177: placebo).
Masking
ParticipantCare ProviderInvestigator
Masking Description
All trial participants, investigator sites, and Sponsor are blinded.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PL8177
Arm Type
Experimental
Arm Description
PL8177 will be given orally and daily from baseline until end of study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.
Intervention Type
Drug
Intervention Name(s)
PL8177 Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.
Intervention Type
Drug
Intervention Name(s)
PL8177
Other Intervention Name(s)
Active study medication
Intervention Description
Approximately 3/4 of randomized patients will receive active PL8177.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of PL8177 compared to placebo inpatients with active UC.
Description
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.
Time Frame
Baseline through Study Completion (Week 12).
Title
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.
Description
Efficacy will be determined through the use of the Mayo Endoscopic Subscore.
Time Frame
Time Frame: Mayo Endoscopic Subscore will be evaluated at Week 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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; 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, 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. 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazish Huq, Director Clinical Operations
Phone
640-203-9744
Email
nhuq@palatin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jordan, VP Clinical Operations
Organizational Affiliation
Palatin; 609-598-1786; rjordan@palatin.com
Official's Role
Study Director
Facility Information:
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Deeb, MD
Phone
520-257-3881
Facility Name
Gastro Care Institute
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duminda Suraweera, MD
Phone
661-529-7550
Facility Name
Valiance Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Sach, MD
Phone
818-938-9167
Facility Name
Advanced Research LLC
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mrinal Garg, MD
Phone
954-204-0052
Facility Name
IHS Health Research/Gastro Health
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Lateef, MD
Phone
407-846-6747
Facility Name
Medical Professional Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Selema, MD
Phone
786-801-1360
Facility Name
Eminat, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaneth Trujillo, MD
Phone
954-374-7547
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udayakumar Navaneethan, MD
Phone
321-842-2273
Facility Name
Alliance Clinical Research of Tampa, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel Crespo, MD
Phone
813-515-5400
Facility Name
Kansas Gastroenterology
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estephan Zayat, MD
Phone
316-928-8976
Facility Name
Gastroenterology Clinic of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacque Noel III, MD
Phone
337-232-6697
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Hinkle III, MD
Phone
318-807-0819
Facility Name
Allied Health Clinical Research Organization, LLC - Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Rubin, MD
Phone
201-992-8272
Facility Name
Allied Digestive Health LLC
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Brown, MD
Phone
732-724-2500
Facility Name
Allied Health Clinical Research Organization, LLC
City
Jackson
State/Province
New Jersey
ZIP/Postal Code
08527
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Basri, MD
Phone
732-685-9434
Facility Name
Weill Cornell Medicine - Jill Roberts Center for Inflammatory Bowel Disease
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Lukin, MD
Phone
646-697-0985
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Schwartz, MD
Phone
773-597-8533
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Al-Assi, MD
Phone
817-471-1070

12. IPD Sharing Statement

Learn more about this trial

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

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