Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome

Summary

This is a pilot, open-label Phase 2, single-center, repeat dose, single cohort, proof-of-concept, safety, pharmacodynamics and efficacy study of dapansutrile capsules to be conducted in subjects with Schnitzler's syndrome (SchS) currently well controlled by anakinra therapy. At least 5 but no more than 10 subjects will be enrolled.

Timeline

Start

2018-05-15

Primary completion

2018-05-29

Completion

2018-05-29

Outcome

Outcome not reported

Stopped: “The study was terminated due to study design issues that did not allow for determination of efficacy and safety in subjects with Schnitzler Syndrome who are currently well controlled on anakinra therapy.”

Drugs

Indications