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Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome

NCT03595371 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

  • Schnitzler Syndrome

Interventions

DRUG

dapansutrile

500 mg dapansutrile administered twice daily (with a potential to increase the dosage to 2 g dapansutrile daily) for a duration of up to 14 consecutive days.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Olatec Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Curt Scribner, MD · Olatec Therapeutics LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2018-05-29
Completion
2018-05-29
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595371 on ClinicalTrials.gov