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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR SM04690

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Clinical Trials for SM04690

Trial ID Title Status Sponsor Phase Summary
NCT02095548 Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA) Completed Samumed LLC Phase 1 The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
NCT02536833 A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Active, not recruiting Samumed LLC Phase 2 The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis subjects.
NCT03122860 A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis Not yet recruiting Samumed LLC Phase 2 This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study will also include two placebo cohorts-one cohort that receives a 2 mL IA injection of vehicle, and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).
NCT03246399 A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease Active, not recruiting Samumed LLC Phase 1 SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135, and 180.
NCT03706521 A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis Not yet recruiting 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 three-dimensional spoiled gradient recalled (3D-SPGR) pulse sequence magnetic resonance imaging (MRI), radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of SM04690.
NCT03727022 A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis Not yet recruiting Samumed LLC Phase 2 The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study is to provide an initial evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. All previous studies of SM04690 have involved a single IA injection for a given subject.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for SM04690

Condition Name

Condition Name for
Intervention Trials
Knee Osteoarthritis 5
Osteoarthritis 1
Moderate to Severe Osteoarthritis 1
Degenerative Disc Disease 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Osteoarthritis 7
Osteoarthritis, Knee 5
Spinal Diseases 1
Intervertebral Disc Degeneration 1
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Clinical Trial Locations for SM04690

Trials by Country

Trials by Country for
Location Trials
United States 106
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Trials by US State

Trials by US State for
Location Trials
California 7
Arizona 6
Texas 6
Florida 5
South Carolina 5
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Clinical Trial Progress for SM04690

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 4
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 5
Active, not recruiting 2
Completed 1
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Clinical Trial Sponsors for SM04690

Sponsor Name

Sponsor Name for
Sponsor Trials
Samumed LLC 8
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 8
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