Current Clinical Trials for OLT1177® Dapansutrile
(click on study title for further information on clinicaltrials.gov or clinicaltrialsregister.eu )
Study OLT1177-08 | Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
A multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177® Capsules), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare.
A multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177® Capsules), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare.
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.
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.
Study OLT1177-10 | OLT1177® Capsules for Moderate COVID-19 Symptoms & Evidence of Early Cytokine Release Syndrome
A Phase 2 randomized, double-blind, placebo-controlled trial of the Safety and Efficacy of orally administered Dapansutrile Capsules (OLT1177® Capsules) for the treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome
A Phase 2 randomized, double-blind, placebo-controlled trial of the Safety and Efficacy of orally administered Dapansutrile Capsules (OLT1177® Capsules) for the treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome
Completed Clinical Trials
(click on study title to link to clinicaltrials.gov or clinicaltrialsregister.eu)
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.
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.
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.
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.
Study OLT1177-06 | OLT1177® Capsules for Cardiovascular Disease
A Phase 1b, randomized, double-blinded, dose escalation, single center, repeat-dose safety and pharmacodynamics study of orally administered investigational drug (OLT1177® Capsules) in subjects with NYHA II-III Systolic Heart Failure.
A Phase 1b, randomized, double-blinded, dose escalation, single center, repeat-dose safety and pharmacodynamics study of orally administered investigational drug (OLT1177® Capsules) in subjects with NYHA II-III Systolic Heart Failure.