At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 318 enrolled
Drug / intervention
EP-104IAR 25 mg +1 moredrug
Likely dose
EP-104IAR 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee
In Brief
A Phase 2 clinical trial evaluating EP-104IAR 25 mg and Vehicle for Osteoarthritis, Knee. Completed, enrolled 318 participants across 12 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesCzechia, Denmark, Poland
CollaboratorsNBCD A/S
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartSep 2021
Primary CompletionMay 2023
Study CompletionJun 2023
TodayJul 2026
First PostedOct 9, 2019
Enrollment StartSep 10, 2021
Primary CompletionMay 17, 2023
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago
Interventions
EP-104IAR 25 mgdrug
Single 5 mL intra-articular injection
Vehicledrug
Single 5 mL intra-articular injection