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.

Clinical Trial Conditions for Lorecivivint

Condition Name

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