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A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04800562
Recruitment Status : Active, not recruiting
First Posted : March 16, 2021
Last Update Posted : February 27, 2023
Information provided by (Responsible Party):
Processa Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 10, 2021
First Posted Date  ICMJE March 16, 2021
Last Update Posted Date February 27, 2023
Actual Study Start Date  ICMJE April 12, 2021
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2021)
Incidence of ulcer closure as assessed by skin exam in patients treated with PCS499 as compared to placebo [ Time Frame: ~ 6 months ]
Evaluation of proportion of patients with wound closure based on skin evaluation in patients with NL as compared with placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
Brief Summary This is a randomized, double blind, placebo controlled study that will evaluate the efficacy and safety of PCS499 as compared to placebo for the treatment of ulcerations of patients with necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 20 ulcerated NL patients who also meet other inclusion/exclusion criteria will be enrolled in the study. The primary objective of this study is to evaluate the efficacy of PCS499 as compared with placebo in ulcerated patients with Necrobiosis Lipoidica.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Necrobiosis Lipoidica
Intervention  ICMJE
  • Drug: PCS499
    PCS499 900mg twice a day with food
  • Other: placebo
    placebo comparator
Study Arms  ICMJE
  • Experimental: PCS499 900mg BID
    PCS499 900mg twice a day with food
    Intervention: Drug: PCS499
  • Placebo Comparator: Placebo
    similar in appearance to active study drug
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 24, 2023)
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2021)
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients age 18 to 80 years of age, inclusive, at Screening.
  2. Biopsy-confirmed diagnosis of NL. Biopsies of continually active lesions performed outside of this clinical study will need to be reviewed and the diagnosis confirmed by the study pathologist. For patients with no previous history of biopsy, no biopsy within the previous 5 years, a biopsy that is not confirmed to be NL, or newly active lesion, a biopsy to confirm a diagnosis of NL will be performed at the Screening visit.
  3. Ulcers on a single leg ("reference leg") at Baseline should consist of at least one (1) ulcer with a minimum ulcer surface area of 1 cm2, total ulcer area of a minimum of 2 cm2, and no more than 6 ulcers. If ulcers are present on both legs, the Investigator will select the "reference leg". The ulcer(s) on the reference leg ("reference ulcers") and all other ulcers associated with the patient's NL ("other ulcers") present at the Baseline visit will be followed in the study.
  4. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Baseline before dosing. Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study: oral contraceptive medication, intrauterine device (IUD), hormonal implants, injectable contraceptive medications, double-barrier methods, or tubal ligation.
  5. Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and increased follicle-stimulating hormone [FSH] > 40 mIU/mL. If necessary to confirm postmenopausal status, an FSH will be drawn at Screening) or who have undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing.
  6. Male patients must be willing to use appropriate contraceptive measures and refrain from sexual activity with any female who is pregnant or lactating.
  7. Patient must be willing and able to swallow whole tablets.
  8. Patient must be willing and able to comply with study procedures.
  9. Patient must be willing and able to provide signed, informed consent.

Exclusion Criteria:

  1. Current or previous (within 4 weeks of Baseline) treatment with:

    1. Oral corticosteroids.
    2. Topical drugs (including prescription and over-the counter) on the reference leg. (Topical non-medicated moisturizer treatment products can be administered);
    3. Systemic pentoxifylline, theophylline, or cilostazol.
    4. Oral retinoid.
    5. Other systemic immunosuppressant or immunomodulatory drugs, including but not limited to calcineurin inhibitors (e.g., tacrolimus), thalidomide, apremilast, anti-malarials (e.g., hydroxychloroquine, chloroquine), cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, etc.
  2. Current or previous (within 12 weeks of Baseline) treatment with any biologic therapy (e.g., adalimumab, etanercept, infliximab, anakinra, etc.).
  3. Phototherapy/photochemotherapy (NBUVB, UVB, PUVA) within 6 weeks prior to Baseline
  4. Skin grafting, or other surgical procedure (other than debridement) within 6 weeks prior to Baseline.
  5. History of drug allergy, including but not limited to pentoxifylline or other xanthine derivatives, or other allergy, which in the opinion of the Investigator, contraindicates participation.
  6. Anticipated concurrent use of a strong CYP1A2 inhibiting drug, including but not limited to cimetidine and/or fluvoxamine, during the course of the study (after Screening).
  7. Fever (>38°C), or chronic, persistent, or recurring infection(s) at Screening or Baseline.
  8. Any infection requiring oral antimicrobial therapy within 2 weeks prior to Baseline or any infection requiring parenteral antibiotics or hospitalization within 12 weeks prior to Baseline. Any treatment for such infections must have been completed and the infection cured for at least 2 weeks prior to Baseline.
  9. History of sarcoidosis, pyoderma gangrenosum, or any other disorder (in the judgment of the Investigator) that would interfere with the evaluation of NL or require protocol prohibited medication.
  10. History of any life threatening infection or sepsis within 12 months of Baseline:
  11. Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of Baseline, and arrhythmia requiring therapy.
  12. Patient has QTc interval ≥ 480 milliseconds on Screening Electrocardiogram (ECG); a second Screening ECG may be done at investigator's discretion but the average of the two QTc screening intervals must not be ≥ 480 milliseconds.
  13. History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of Baseline.
  14. Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to Baseline.
  15. Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and/or any other clinically significant disease or disorder, which in the opinion of the Investigator (by its nature or by being inadequately controlled), may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.
  16. History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration >= 5 millimeter (mm), or a positive QuantiFERON-TB test or positive or borderline T-Spot [Elispot] test); or positive TB test at Screening. Subjects with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.
  17. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Baseline.
  18. The results of the following laboratory tests performed at the central laboratory at Screening meet any of the criteria below:

    1. Hemoglobin < 8.0 g/dL (International System of Units (SI): < 80 g/L);
    2. White blood cells < 3.0 x 10^3 cells/mm^3 (SI: < 3.0 x 10^9 cells/L);
    3. Neutrophils < 1.0 x 10^3 cells/mm^3 (SI: < 1.0 x 10^9 cells/L);
    4. Lymphocytes < 0.5 x 10^3 cells/mm^3 (SI: < 0.5 x 10^9 cells/L);
    5. Platelets < 100 x 10^3 cells/mm^3 (SI: < 100 x 10^9 cells/L)
    6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) ≥ 2 x upper limit of normal (ULN);
    7. Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented;
    8. Estimated glomerular filtration rate < 40 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) formula.
    9. HbA1c > 10%
    10. Positive HIV serology
    11. Evidence of active Hepatitis B Virus (HBV) infection
    12. Evidence of active Hepatitis C Virus (HCV) infection
  19. Women who are pregnant or breastfeeding.
  20. Patient unwilling or unable to swallow tablets whole.
  21. Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
  22. Use of any investigational product within 30 days prior to Baseline or currently enrolled in another study that involves clinical investigations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Ukraine
Administrative Information
NCT Number  ICMJE NCT04800562
Other Study ID Numbers  ICMJE PCS499-NL02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Processa Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Processa Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sian Bigora, PharmD Processa Pharmaceuticals
PRS Account Processa Pharmaceuticals
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP