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NCT03072953

Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum

Terminated Phase 2 Results posted Last updated 11 June 2021
What this trial tests

Phase 2 trial testing APD334 in Pyoderma Gangrenosum in 2 participants. Terminated before completion.

Timeline
7 June 2017
Primary endpoint
22 May 2018
22 May 2018

Quick facts

Lead sponsorArena Pharmaceuticals
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment2
Start date7 June 2017
Primary completion22 May 2018
Estimated completion22 May 2018
Sites6 locations across New Zealand, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Arena Pharmaceuticals — full company profile →

Who can join

Adults 18 to 80, any sex, with Pyoderma Gangrenosum. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements Secondary · Up to approximately 12 weeks

Safety was assessed by monitoring and recording all adverse events, clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis), physical and neurological examinations, vital sign measurements, and 12-lead electrocardiograms. The number of participants with adverse events and CS safety measures have been reported.

GroupValue95% CI
APD3342
APD3340
APD3340
APD3340

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

APD334
Serious: 0/2 (0%)
Deaths: 0/2
Other adverse events (4 terms — click to expand)

ReactionSystemAPD334
DiarrheaGastrointestinal disorders
headacheNervous system disorders
PruritusSkin and subcutaneous tissue disorders
Sore hipInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03072953 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting Sphingosine-1-Phosphate Signaling in Immune-Mediated Diseases: Beyond Multiple Sclerosis.
    Pérez-Jeldres T, Alvarez-Lobos M, Rivera-Nieves J. · · 2021 · cited 150× · PMID 33983615 · DOI 10.1007/s40265-021-01528-8
  2. The S1P-S1PR Axis in Neurological Disorders-Insights into Current and Future Therapeutic Perspectives.
    Lucaciu A, Brunkhorst R, Pfeilschifter JM, Pfeilschifter W, et al · · 2020 · cited 53× · PMID 32580348 · DOI 10.3390/cells9061515
  3. Sphingolipids in Lung Pathology in the Coronavirus Disease Era: A Review of Sphingolipid Involvement in the Pathogenesis of Lung Damage.
    Khan SA, Goliwas KF, Deshane JS. · · 2021 · cited 17× · PMID 34690821 · DOI 10.3389/fphys.2021.760638
  4. Barrier maintenance by S1P during inflammation and sepsis.
    Ziegler AC, Gräler MH. · · 2021 · cited 10× · PMID 34152926 · DOI 10.1080/21688370.2021.1940069

Verify or expand the search:

Other trials of APD334

Trials testing the same drug.

Other recruiting trials for Pyoderma Gangrenosum

Currently open trials in the same condition.

Other Arena Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03072953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing