Current Clinical Trials for Dapansutrile (OLT1177)
​(click on study title to link to clinicaltrialsregister.eu​)

Study OLT1177-05 | OLT1177 Capsules for an Acute Gout Flare
A Phase 2a, single-center, sequential, adaptive dose progression proof-of-concept safety and efficacy study of orally administered investigational drug (OLT1177 Capsules) in subjects with an acute gout flare. This study will enroll up to 24 subjects in a single site in Venlo, Netherlands.

Study OLT1177-07 | OLT1177 Capsules for a Rare Disease
A Phase 2 pilot, open-label, single-center, repeat dose, proof-of-concept safety, pharmacodynamics and efficacy study of orally administered investigational drug (OLT1177 Capsules) in subjects with a rare disease called Schnitzler’s Syndrome. This study will enroll up to 12 subjects in a single site in Venlo, Netherlands. 

Completed Clinical Trials
​(click on study title to link to clinicaltrials.gov)

Study OLT1177-01 | OLT1177 Gel Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Gel or Placebo Gel).  A total of 36 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.

Study OLT1177-02 | OLT1177 Gel for Knee OA
A Phase 2a randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177 Gel or Placebo Gel) for two weeks.  A total of 79 subjects were enrolled and randomized in a ratio of 2 active to 1 placebo.

Study OLT1177-03 | OLT1177 Gel for Knee OA
A Phase 2b randomized, placebo-controlled safety and efficacy study of subjects with moderate-to-severe osteoarthritis of the knee following treatment with investigational drug (OLT1177 Gel or Placebo Gel) for six weeks.  A total of 202 subjects were enrolled and randomized in a ratio of 1 active to 1 placebo.

Study OLT1177-04 | OLT1177 Capsules Safety Study
A Phase 1 randomized, placebo-controlled, sequential ascending-dose safety and pharmacokinetic study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Capsules or Placebo Capsules).  A total of 35 subjects were enrolled across 6 cohorts randomized in a ratio of 5 active to 1 placebo.