Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum (NCT03072953) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum
Stopped: Terminated \[Sponsor decision to terminate the study\]
Australia2 participantsStarted 2017-06-07
Plain-language summary
The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female (18-80 years).
✓. Able to provide a signed informed consent prior to any study related procedure being conducted.
✓. Diagnosis of PG with active, non-healing ulcer.
✓. Considered to be in stable health in the opinion of the investigator as determined by:
✓. A screening physical examination with no clinically significant abnormalities unrelated to PG.
✓. Liver function tests (alanine aminotransferase/aspartate aminotransferase, bilirubin and alkaline phosphatase) \< 2x the upper limit of normal.
Exclusion criteria
✕. No clinical abnormalities noted in the12-lead electrocardiogram in the opinion of the investigator (Refer also to exclusion criterion 13).
✕. No evidence of macular edema in an ophthalmology evaluation (performed by an ophthalmologist), supported with optical coherence tomography, where available (dependent on site capability) at screening.
✕. Eligible male and female participants must agree not to participate in a conception process (i.e. active attempt to let female partner to become pregnant or to impregnate, sperm donation, oocyte donation, in vitro fertilization) for at least 30 days after the last dose of study drug.
✕
What they're measuring
1
Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Manifestations
Timeframe: Week 12
2
Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin Manifestations
Timeframe: Week 12
3
Exploratory Endpoint - Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Timeframe: Week 12
4
Exploratory Endpoint - Change From Baseline in C-reactive Protein Levels
Timeframe: Week 12
5
Exploratory Endpoint - Assessments of Target Lesions
Timeframe: Week 12
6
Exploratory Endpoint - Assessment of Punch Biopsies
. Clinically significant infection as judged by the investigator with an end date less than 6-weeks prior to treatment start (Day 1). In case of infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection, this infection must have ended at least 8 weeks prior to Day 1.
✕. Infection with hepatitis C virus anytime in the past; confirmed active infection with hepatitis B virus at screening.
✕. History of severe renal or severe hepatic impairment.