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PCS499

Phase 2

Necrobiosis Lipoidica | Small molecule | Dermatology |Processa Pharmaceuticals, Inc.|Last Updated: Oct 3, 2022

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical trial landscape

PCS499 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT03698864A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis LipoidicaNecrobiosis Lipoidica
COMPLETED12 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
Necrobiosis Lipoidica
NCT0369886412
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Study Endpoints
Primary Endpoints
Evaluation of Patients With Adverse Events
12 months

Evaluation of Adverse Events/Serious Adverse Events (by type, severity, and relatedness)

Maximum plasma concentrations (Cmax) for Part 1
Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.

Serial blood sampling at specified time points for determination of plasma concentration-time profiles

Maximum plasma concentrations (Cmax) in Part 2
Blood sampling will be drawn prior to the single dose administration on Days 1 & 4 and at 11 other timepoints in the following 24 hours. In addition, pre-dose trough samples will be taken on Days 2 &3.

Serial blood sampling at specified time points for determination of plasma concentration-time profiles

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PCS499 900mg twice a dayEXPERIMENTAL -
PCS499 MR Tablet Prototype 2EXPERIMENTAL600 mg single dose
Trental MR tablet 400mgACTIVE_COMPARATORsingle dose
PCS499 MR Tablet Prototype 4EXPERIMENTAL600mg single dose
PCS499 MR Tablet Prototype 1EXPERIMENTAL600mg single dose
Trental MR TabletACTIVE_COMPARATOR400 mg multiple dose
PCS499 MR Tablet 900mgEXPERIMENTALmultiple dose
PCS499 MR Tablet 600mgEXPERIMENTALmultiple dose
Interventions
NameTypeDescription
PCS499DRUGPCS499 900mg twice a day with food
TrentalDRUGcomparator tablet
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 ...

Countries:United StatesUnited Kingdom
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