CLINICAL TRIALS PROFILE FOR DAPANSUTRILE

Clinical Trials for Dapansutrile

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03534297 ↗	Study of Dapansutrile Capsules in Heart Failure	Completed	Olatec Therapeutics LLC	Phase 1	This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show signs of systemic inflammation (high sensitivity plasma C reactive protein [hsCRP] > 2 mg/L). A total of 30 subjects will be enrolled in 3 sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort). Progression to cohort 2 with dose escalation will occur following the Day 28 visit of the last subject in the first cohort. Progression to cohort 3 with dose escalation will occur following the Day 8 visit of the last subject in the second cohort. Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once, twice or four times daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42.
NCT03595371 ↗	Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome	Recruiting	Radboud University	Phase 2	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.
NCT03595371 ↗	Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome	Recruiting	Olatec Therapeutics LLC	Phase 2	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.

Clinical Trial Conditions for Dapansutrile

Condition Name

Condition Name
Intervention	Trials
Gout Attack	1
Gout Flare	1
Gouty Arthritis	1

Condition MeSH

Condition MeSH
Intervention	Trials
Syndrome	2
Gout	1
Arthritis, Gouty	1

Clinical Trial Locations for Dapansutrile

Trials by Country

Trials by Country
Location	Trials
United States	6
Switzerland	2
Netherlands	2

Trials by US State

Trials by US State
Location	Trials
Virginia	2
Texas	1
North Carolina	1
Florida	1
Colorado	1

Clinical Trial Progress for Dapansutrile

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	2
Completed	1

Clinical Trial Sponsors for Dapansutrile

Sponsor Name

Sponsor Name
Sponsor	Trials
Olatec Therapeutics LLC	6
Merck Sharp & Dohme Corp.	1
April Salama, M.D.	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7
Other	7