- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660424
A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee
September 22, 2020 updated by: Vertex Pharmaceuticals Incorporated
A Phase 2a Randomized, Double-blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee
The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of osteoarthritis pain
Study Overview
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States
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Florida
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West Palm Beach, Florida, United States
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Georgia
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Marietta, Georgia, United States
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Indiana
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Valparaiso, Indiana, United States
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Kansas
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Wichita, Kansas, United States
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Michigan
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Bay City, Michigan, United States
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Nevada
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Las Vegas, Nevada, United States
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New York
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Hartsdale, New York, United States
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Pennsylvania
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Duncansville, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Virginia
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Danville, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
- Subjects (male and female [of non-childbearing potential]) will be between the ages of 40 and 80 years, inclusive. Female subjects must have a negative pregnancy test at Screening and on Day 1 of each Treatment Period and must not be nursing; male subjects must not have a female partner who is pregnant or nursing.
- Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive, and a total body weight of 50 to 150 kg.
- Ambulatory with osteoarthritis of the knee with symptoms for at least 6 months and pain on the majority of days for the past 30 days. Symptoms must include knee joint pain. In subjects with bilateral knee osteoarthritis, the more symptomatic knee will be considered the index knee.
- Radiographic evidence of at least one tibiofemoral osteophyte in the index knee within 12 months before the Day 1 Visit.
- WOMAC pain subscale score
Exclusion Criteria:
- History in the past 10 years of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- History in the past 10 years of malignancy with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin or resected cervical atypia or carcinoma in situ.
- History of cardiac dysrhythmias requiring anti-arrythmia treatment(s).
- History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator would preclude the subjects participation in the study.
- A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses.
- Other serious, acute or chronic medical or psychiatric illness that in the judgment of the investigator could compromise subject safety, limit the subject's ability to complete the study and/or compromise the objectives of the study.
- Either participated within 3 months in another investigational study in which the subject was exposed to study drugs or vaccines,or will participate concurrently in such study.
- History of drug or alcohol dependence in the past 3 years, or a positive test for drugs of abuse at the Screening Visit.
- Requires opioids for pain relief.
- Changed analgesic treatment regimen within 30 days of the Screening Visit.
Received or plan to receive short acting hyaluronic acid, corticosteroid, or other intra-articular injections as follows:
- in the index knee within 3 months of the Screening Visit, or at any time during the study
- in any other joint within 4 weeks of the Screening Visit, or at any time during the study
Received or plan to receive long acting hyaluronic acid or other intra-articular injections as follows:
- in the index knee within 6 months of the Screening Visit, or at any time during the study
- in any other joint within 4 weeks of the Screening Visit, or at any time during the study
- History of arthroscopic or open surgery within 12 months before the Screening Visit, or have a planned surgery during, or immediately after, study follow-up.
- History of joint replacement surgery in the index knee.
- Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain.
- Clinical signs and symptoms of an active knee infection.
- Current use of a handicap assistance device (unilateral assistance device such as a cane is permitted).
- Started a new physical therapy, weight loss, or exercise program within 3 months of the Screening Visit, or are not willing to maintain a stable program during the course of the study.
- Lab abnormalities at the screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: VX-150, placebo
Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2
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Experimental: placebo, VX-150
Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index pain subscale score at Day 14
Time Frame: from baseline at Day 14
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from baseline at Day 14
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with ≥50% reduction in WOMAC pain subscale at Day 14
Time Frame: at Day 14
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at Day 14
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Change from baseline in total WOMAC score at Day 14
Time Frame: at Day 14
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at Day 14
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Use of rescue medications [to be obtained by electronic diary and questionnaire]
Time Frame: Treatment periods1 (14 days) and 2 (14 days)
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Treatment periods1 (14 days) and 2 (14 days)
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Safety and tolerability based on the incidence and type of adverse events (AEs),changes from baseline in clinically significant laboratory test results, and assessment of 12 lead electrocardiograms (ECGs) and vital signs at designated visits.
Time Frame: up to 12 weeks (duration of study)
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up to 12 weeks (duration of study)
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Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Cmax [maximum plasma concentrations]
Time Frame: Days 1,14 of each treatment periods
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Days 1,14 of each treatment periods
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Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Tmax [time to maximum plasma concentration]
Time Frame: Days 1,14 of each treatment periods
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Days 1,14 of each treatment periods
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Plasma PK parameters of prodrug, VX-150 and its primary metabolite: AUC [area under the plasma concentration-time curve]
Time Frame: Days 1,14,16,18 of each treatment periods
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Days 1,14,16,18 of each treatment periods
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
December 18, 2015
First Submitted That Met QC Criteria
January 20, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Actual)
September 30, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX15-150-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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