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Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

NCT ID: NCT02095548

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate to Severe Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SM04690, 0.03mg/2mL

Single, intra-articular injection of SM04690, 0.03mg/2mL

Group Type EXPERIMENTAL

SM04690, 0.03mg/2mL

Intervention Type DRUG

SM04690, 0.07mg/2mL

Single, intra-articular injection of SM04690, 0.07mg/2mL

Group Type EXPERIMENTAL

SM04690, 0.07mg/2mL

Intervention Type DRUG

SM04690, 0.23mg/2mL

Single, intra-articular injection of SM04690, 0.23mg/2mL

Group Type EXPERIMENTAL

SM04690, 0.23mg/2mL

Intervention Type DRUG

Placebo

Single, intra-articular injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SM04690, 0.03mg/2mL

Intervention Type DRUG

SM04690, 0.07mg/2mL

Intervention Type DRUG

SM04690, 0.23mg/2mL

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
* Screening pain criteria sufficient as assessed by WOMAC and VAS scores
* Ability to read and understand the informed consent

Exclusion Criteria

* Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
* Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
* Body mass index \>40
* Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
* History of malignancy within the last 5 years
* Participation in a clinical research trial within 12 weeks prior
* Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
* Effusion of the target knee requiring aspiration within 3 months
* Use of electrotherapy or acupuncture for OA within 4 weeks
* Significant and clinically evident misalignment of the target knee
* Any known active infections
* Any chronic condition that has not been well controlled for a minimum of 3 months
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosplice Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson, Arizona, United States

Site Status

El Cajon, California, United States

Site Status

Walnut Creek, California, United States

Site Status

Miami, Florida, United States

Site Status

Boston, Massachusetts, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Yazici Y, McAlindon TE, Fleischmann R, Gibofsky A, Lane NE, Kivitz AJ, Skrepnik N, Armas E, Swearingen CJ, DiFrancesco A, Tambiah JRS, Hood J, Hochberg MC. A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: results of a 24-week, randomized, controlled, phase 1 study. Osteoarthritis Cartilage. 2017 Oct;25(10):1598-1606. doi: 10.1016/j.joca.2017.07.006. Epub 2017 Jul 13.

Reference Type DERIVED
PMID: 28711582 (View on PubMed)

Other Identifiers

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SM04690-01

Identifier Type: -

Identifier Source: org_study_id