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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)

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ClinicalTrials.gov Identifier: NCT02095548
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Osteoarthritis Drug: SM04690, 0.03mg/2mL Drug: SM04690, 0.07mg/2mL Drug: SM04690, 0.23mg/2mL Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Study Start Date : March 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SM04690, 0.03mg/2mL
Single, intra-articular injection of SM04690, 0.03mg/2mL
Drug: SM04690, 0.03mg/2mL
Experimental: SM04690, 0.07mg/2mL
Single, intra-articular injection of SM04690, 0.07mg/2mL
Drug: SM04690, 0.07mg/2mL
Experimental: SM04690, 0.23mg/2mL
Single, intra-articular injection of SM04690, 0.23mg/2mL
Drug: SM04690, 0.23mg/2mL
Placebo Comparator: Placebo
Single, intra-articular injection of placebo
Drug: Placebo



Primary Outcome Measures :
  1. Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests [ Time Frame: during 24 weeks ]
  2. Additional safety assessment of bone loss as measured by CT of the knee [ Time Frame: during 24 weeks ]
  3. The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2 [ Time Frame: during 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS) [ Time Frame: during 24 weeks ]
  2. Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale [ Time Frame: During 24 weeks ]
  3. Change from baseline per physician global assessment of disease scale [ Time Frame: during 24 weeks ]
  4. Change from baseline in joint space width as measured by X-ray [ Time Frame: during 24 weeks ]
  5. Change from baseline of cartilage volume and thickness as measure by MRI [ Time Frame: during 24 weeks ]
  6. Change from baseline of biomarkers of cartilage synthesis and cytokines [ Time Frame: during 24 weeks ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095548


Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
El Cajon, California, United States
Walnut Creek, California, United States
United States, Florida
Miami, Florida, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Samumed LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02095548     History of Changes
Other Study ID Numbers: SM04690-01
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases