CLINICAL TRIALS PROFILE FOR LORECIVIVINT

Clinical Trials for Lorecivivint

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03706521 ↗	A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Biosplice Therapeutics, Inc.	Phase 2	This phase 2 study is a single center, open-label study of SM04690 injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg SM04690 per 2 mL injection. This study will utilize magnetic resonance imaging (MRI) (including T1rho and T2 mapping pulse sequence MRI, three-dimensional spoiled gradient recalled [3D-SPGR] pulse sequence MRI, and whole organ MRI scoring [WORMS]), radiographic imaging, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and patient reported outcomes (PROs) for data collection to assess efficacy outcome measures.
NCT03706521 ↗	A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Samumed LLC	Phase 2	This phase 2 study is a single center, open-label study of SM04690 injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg SM04690 per 2 mL injection. This study will utilize magnetic resonance imaging (MRI) (including T1rho and T2 mapping pulse sequence MRI, three-dimensional spoiled gradient recalled [3D-SPGR] pulse sequence MRI, and whole organ MRI scoring [WORMS]), radiographic imaging, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and patient reported outcomes (PROs) for data collection to assess efficacy outcome measures.
NCT03928184 ↗	A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Biosplice Therapeutics, Inc.	Phase 3	This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
NCT03928184 ↗	A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Samumed LLC	Phase 3	This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
NCT04385303 ↗	A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Biosplice Therapeutics, Inc.	Phase 3	This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
NCT04385303 ↗	A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Completed	Samumed LLC	Phase 3	This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
NCT04520607 ↗	A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee	Recruiting	Biosplice Therapeutics, Inc.	Phase 3	This study is designed as a long-term extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects with knee osteoarthritis (OA). The first 48 weeks will be single-blind and placebo-controlled while the remainder of the study will be open-label and uncontrolled. Subjects must enroll no later than 6 weeks following completion of the parent-study.

Clinical Trial Conditions for Lorecivivint

Condition Name

Condition Name
Intervention	Trials
Knee Osteoarthritis	4
Drug-Drug Interaction	1
Osteoarthritis of the Knee	1
Osteoarthritis, Knee	1

Condition MeSH

Condition MeSH
Intervention	Trials
Osteoarthritis, Knee	6
Osteoarthritis	6

Clinical Trial Locations for Lorecivivint

Trials by Country

Trials by Country
Location	Trials
United States	90

Trials by US State

Trials by US State
Location	Trials
Florida	6
Illinois	4
Arizona	4
California	4
Texas	4

Clinical Trial Progress for Lorecivivint

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	1
Phase 1	1

Clinical Trial Status

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

Clinical Trial Sponsors for Lorecivivint

Sponsor Name

Sponsor Name
Sponsor	Trials
Biosplice Therapeutics, Inc.	7
Samumed LLC	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	12