Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica (NCT NCT03698864)

Last Updated: 2022-10-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

12 months

Results posted on

2022-10-03

Participant milestones
Measure	PCS499 900mg Twice a Day PCS499: PCS499 900mg twice a day with food
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Withdrawal data not reported

A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

Baseline characteristics by cohort
Measure	PCS499 900mg Twice a Day n=12 Participants PCS499: PCS499 900mg twice a day with food
Age, Continuous	38.8 years STANDARD_DEVIATION 13.63 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Screening Body Mass Index	28.80 kg/m2 STANDARD_DEVIATION 3.338 • n=99 Participants
Number of Days since NL diagnosis to screening	4498.25 days STANDARD_DEVIATION 3759.580 • n=99 Participants

Timeframe: 12 months

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

Outcome measures
Measure	PCS499 900mg Twice a Day n=12 Participants PCS499: PCS499 900mg twice a day with food
Evaluation of Patients With Adverse Events	10 Participants

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	PCS499 900mg Twice a Day n=12 participants at risk PCS499: PCS499 900mg twice a day with food
Gastrointestinal disorders Nausea	33.3% 4/12 • 1 year
Gastrointestinal disorders Abdominal Discomfort	8.3% 1/12 • 1 year
Gastrointestinal disorders Dry Mouth	8.3% 1/12 • 1 year
Infections and infestations Influenza	16.7% 2/12 • 1 year
Blood and lymphatic system disorders Anaemia	8.3% 1/12 • 1 year
General disorders Ulcer	8.3% 1/12 • 1 year
Infections and infestations Abcess	8.3% 1/12 • 1 year
Infections and infestations Gastroenteritis Viral	8.3% 1/12 • 1 year
Infections and infestations Rash Pustular	8.3% 1/12 • 1 year
Infections and infestations Tooth Abcess	8.3% 1/12 • 1 year
Infections and infestations Upper Respiratory Tract Infection	8.3% 1/12 • 1 year
Injury, poisoning and procedural complications Eschar	8.3% 1/12 • 1 year
Investigations Blood Glucose Increased	8.3% 1/12 • 1 year
Investigations Electrocardiogram Qt Prolonged	8.3% 1/12 • 1 year
Metabolism and nutrition disorders Decreased Appetite	8.3% 1/12 • 1 year
Metabolism and nutrition disorders Hyperkalaemia	8.3% 1/12 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	8.3% 1/12 • 1 year
Nervous system disorders Dizziness	8.3% 1/12 • 1 year
Nervous system disorders Migraine	8.3% 1/12 • 1 year
Renal and urinary disorders Proteinuria	8.3% 1/12 • 1 year
Skin and subcutaneous tissue disorders Alopecia	8.3% 1/12 • 1 year

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