NCT03978208

Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients

A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Antibe Therapeutics Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.

Detailed description

The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of once daily administration of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.A total of 360 evaluable patients are planned in this study: 250 mg (n=120); 200 mg (n=120); 150 mg (n=60); placebo (n=60). Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	ATB-346 low dose	Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
OTHER	Placebo	Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
DRUG	ATB-346 mid-dose	Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
DRUG	ATB-346 standard dose	Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients

Timeline

• Start date: 2019-03-29
• Primary completion: 2019-12-29
• Completion: 2019-12-29
• First posted: 2019-06-07
• Last updated: 2022-07-21

Locations

35 sites across 1 country: Canada