lorecivivint: Clinical Trials

8 completed, 4 terminated. 5 Phase 3, 4 Phase 2, 3 Phase 1.

By phase and status

Phase	Trials	Status
Phase 3	5	Completed 3, Terminated 2
Phase 2	4	Completed 3, Terminated 1
Phase 1	3	Completed 2, Terminated 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES) Lorecivivint, Placebo - Knee Osteoarthritis	Phase 3	Completed	Biosplice Therapeutics, Inc.	499	2022-11-18	2026-09-01
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis Lorecivivint - Osteoarthritis of the Knee	Phase 3	Terminated	Biosplice Therapeutics, Inc.	72	2021-07-15	2026-03-31
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers Lorecivivint (LOR), Triamcinolone acetonide (TA) - Drug-Drug Interaction	Phase 1	Completed	Biosplice Therapeutics, Inc.	40	2020-10-13	2021-01-12
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee Placebo, Lorecivivint - Osteoarthritis, Knee	Phase 3	Terminated	Biosplice Therapeutics, Inc.	276	2020-08-25	2026-03-24
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1) Lorecivivint, Placebo - Knee Osteoarthritis	Phase 3	Completed	Biosplice Therapeutics, Inc.	496	2020-05-26	2026-02-04
Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis Lorecivivint, Placebo - Knee Osteoarthritis	Phase 3	Completed	Biosplice Therapeutics, Inc.	501	2019-05-17	2026-02-13
MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis lorecivivint - Knee Osteoarthritis	Phase 2	Terminated	Biosplice Therapeutics, Inc.	13	2019-03-11	2026-03-04
Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis Placebo, SM04690 - Knee Osteoarthritis	Phase 2	Completed	Biosplice Therapeutics, Inc.	101	2018-11-28	2026-01-12
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease SM04690 - Degenerative Disc Disease	Phase 1	Terminated	Biosplice Therapeutics, Inc.	6	2017-07-26	2019-04-23
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis SM04690, Placebo, Sham - Knee Osteoarthritis	Phase 2	Completed	Biosplice Therapeutics, Inc.	700	2017-04-24	2021-06-11
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects SM04690, Placebo - Osteoarthritis	Phase 2	Completed	Biosplice Therapeutics, Inc.	455	2015-09-09	2021-03-17
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA) SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL, SM04690, 0.23mg/2mL - Moderate to Severe Osteoarthritis	Phase 1	Completed	Biosplice Therapeutics, Inc.	61	2014-03-01	2015-12-10

Conditions studied

Osteoarthritis (8)  ·  Osteoarthritis, Knee (8)  ·  Intervertebral Disc Degeneration (1)

Sponsors

Biosplice Therapeutics, Inc. (12)

Countries

United States (12)

Top investigators

Yusuf Yazici, M.D. (8)  ·  Yusuf Yazici, MD (2)  ·  Ismail Simsek, MD (1)

Results publications

PMID 39495154, PMID 28711582, PMID 32432388, PMID 33588087, PMID 34101138, PMID 35005990, PMID 37902943