Necrobiosis Lipoidica

Study Information

This is a research study to test a new drug (also called investigational drug) named PCS499. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA), which is a federal agency involved in regulating medicines in the United States. Before a new drug can be prescribed by doctors, it must be tested and approved by the FDA. The goal of this research study is to test PCS499 (the investigational drug) compared to placebo to see if it is safe and if it works as the sponsor believes it might. A placebo is a tablet that looks exactly like the PCS499 tablet but has no active drug in it. You will have an equal chance (like flipping a coin) of receiving PCS499 or placebo. You and the study doctor will not know what you get, but your study doctor can find out in an emergency. For this study, “study drug” refers to either PCS499 or placebo. The main purpose of this research study is to test the efficacy (how well the drug works) and safety of PCS499, which will only be given to patients who have ulcerations due to their NL.

Processa Pharmaceuticals has initiated a randomized, double blind, placebo controlled study that will evaluate the efficacy and safety of PCS499 (an investigational oral medication from Processa Pharmaceuticals) as compared to placebo for the treatment of ulcerations of patients with Necrobiosis Lipoidica (NL). Approximately 20 patients with ulcers due to their NL who also meet other inclusion/exclusion criteria will be enrolled in the study.

There is NO COST to you to participate in the trial. Processa Pharmaceuticals will cover travel costs (air, train, hotel, etc) for patient’s needing to travel to clinical sites.

Click here to contact a clinical investigator to set up a medical consultation.

DURATION

Patients will be in the study for 7.5 months with 9 visits

ENROLLMENT GOAL

20 Patients

TREATMENT

Drug: PCS499
PCS499 900mg twice a day with food

OR

Other: placebo

SPONSOR

Processa Pharmaceuticals

Processa Pharmaceuticals

The purpose of this study is to investigate the safety and effectiveness of a potential treatment for Necrobiosis Lipoidica. Your participation in this study will help increase the knowledge and understanding of your condition and its treatment options. Participants may be required to attend up to 9 visits over the course of 7.5 months. Once you contact a clinical investigator, you will be asked to do the following:

1. SIGN UP

Contact the Clinical Investigator’s office to begin the sign-up process.

2. PHONE CALL/TEXT

The study team reviews your information. If the study might be a good fit, someone will contact you for further information or to schedule a screening visit.

3. SCREENING VISIT

The research site will assess if you are fully qualified to participate in the study. All of the study details will be explained to you at this time.

4. STUDY PARTICIPATION

Fully qualified participants may be offered the chance to enroll and receive the study treatment over the course of the study.
Inclusion Criteria
  1. Do you have at least one open ulcer on your lower leg that is the size of a nickel?
  2. Are you willing to have blood drawn, swallow pills, and travel to the study clinic for visits?
  3. Have you been previously diagnosed with Necrobiosis Lipoidica?
    • If YES, Have you had a recent biopsy within the past 5 years?
    • If NO, Are you willing to have a biopsy to confirm diagnosis of your Necrobiosis Lipoidica?
  4. Are you between the age of 18 and 80 years old?
  5. Do you have up to 6 ulcers on your lower leg?
  6. Are you willing to come to the clinic for visits?
Exclusion Criteria
  1. Please list any medications you have taken in the past 6 weeks (including topical cream, prescription, and over the counter).
  2. Have you received any treatment with a biologic (e.g, adalimumab, etanercept, infliximab, anakinra, etc.) within the last 12 weeks?
  3. Have you received Phototherapy or photochemotherapy within the last 6 weeks?
  4. Within the last 6 weeks have you had a skin grafting or other surgical procedure?
  5. Do you have a history of any drug allergies, including but not limited to pentoxifylline or other xanthine derivatives, or other allergies?
  6. Do you currently have fever, or chronic, persistent, and recurring infection?
  7. Have you had any infection within the last 12 weeks that required oral or injected antibiotics, or hospitalization?
  8. Do you have a history of Sarcoidosis (tender red growths affecting the lungs / skin / lymph nodes) Or Pyoderma Gangrenosum (causes large, painful sores (ulcers) to develop on your skin)?
  9. Have you had any life-threatening infection or sepsis in the last 12 months?
  10. Have you had any significant cardiac disease in the last 6 months (e.g. angina or heart attack)?
  11. Do you have QT syndrome (a heart rhythm condition)?
  12. Within the last 6 months have you had any stroke, brain bleeding, gastrointestinal bleeding, or bleeding from the retina/ eye?
  13. Have you had any cancer or tumors in the past 5 years?
  14. Do you currently have a diagnosis of active tuberculosis within the last 3 months?
  15. Have you had a live vaccine within the last month?
  16. Have you participated in a clinical investigation within the last 30 days, or intend to participate in another clinical investigation during the course of this study?