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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • San Diego, California, United States
    • Florida
      • West Palm Beach, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Indiana
      • Valparaiso, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Michigan
      • Bay City, Michigan, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Hartsdale, New York, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Virginia
      • Danville, Virginia, United States

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

    1. in the index knee within 3 months of the Screening Visit, or at any time during the study
    2. 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:

    1. in the index knee within 6 months of the Screening Visit, or at any time during the study
    2. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VX-150, placebo
Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2
Drug: Placebo
Drug: VX-150
Experimental: placebo, VX-150
Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2
Drug: Placebo
Drug: VX-150

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
from baseline at Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with ≥50% reduction in WOMAC pain subscale at Day 14
Time Frame: at Day 14
at Day 14
Change from baseline in total WOMAC score at Day 14
Time Frame: at Day 14
at Day 14
Use of rescue medications [to be obtained by electronic diary and questionnaire]
Time Frame: Treatment periods1 (14 days) and 2 (14 days)
Treatment periods1 (14 days) and 2 (14 days)
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)
up to 12 weeks (duration of study)
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Cmax [maximum plasma concentrations]
Time Frame: Days 1,14 of each treatment periods
Days 1,14 of each treatment periods
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
Days 1,14 of each treatment periods
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
Days 1,14,16,18 of each treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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