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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 18, 2014
First Posted Date  ICMJE March 26, 2014
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • 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 ]
  • Additional safety assessment of bone loss as measured by CT of the knee [ Time Frame: during 24 weeks ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS) [ Time Frame: during 24 weeks ]
  • Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale [ Time Frame: During 24 weeks ]
  • Change from baseline per physician global assessment of disease scale [ Time Frame: during 24 weeks ]
  • Change from baseline in joint space width as measured by X-ray [ Time Frame: during 24 weeks ]
  • Change from baseline of cartilage volume and thickness as measure by MRI [ Time Frame: during 24 weeks ]
  • Change from baseline of biomarkers of cartilage synthesis and cytokines [ Time Frame: during 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Osteoarthritis
Intervention  ICMJE
  • Drug: SM04690, 0.03mg/2mL
  • Drug: SM04690, 0.07mg/2mL
  • Drug: SM04690, 0.23mg/2mL
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: SM04690, 0.03mg/2mL
    Single, intra-articular injection of SM04690, 0.03mg/2mL
    Intervention: Drug: SM04690, 0.03mg/2mL
  • Experimental: SM04690, 0.07mg/2mL
    Single, intra-articular injection of SM04690, 0.07mg/2mL
    Intervention: Drug: SM04690, 0.07mg/2mL
  • Experimental: SM04690, 0.23mg/2mL
    Single, intra-articular injection of SM04690, 0.23mg/2mL
    Intervention: Drug: SM04690, 0.23mg/2mL
  • Placebo Comparator: Placebo
    Single, intra-articular injection of placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
61
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
60
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02095548
Other Study ID Numbers  ICMJE SM04690-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samumed LLC
Study Sponsor  ICMJE Samumed LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samumed LLC
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP