OsteoarthritisPhase 2NCT02660424
A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee
A Phase 2 study testing VX-150 in people with Osteoarthritis, run by Vertex Pharmaceuticals Incorporated at 12 sites in United States.
Trial summary
The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of osteoarthritis pain Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- VX-150
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Bay City, Michigan
Study site
Chattanooga, Tennessee
Study site
Danville, Virginia
Study site
Duncansville, Pennsylvania
Study site
Hartsdale, New York
Study site
Las Vegas, Nevada
Study site
Marietta, Georgia
Study site
Providence, Rhode Island
Study site
San Diego, California
Study site
Valparaiso, Indiana
Study site
West Palm Beach, Florida
Study site
Wichita, Kansas
About this study
Official title: 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
- Conditions
- Osteoarthritis
- Being tested
- VX-150, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-150Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VX-150, placebo | Experimental | Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2 Receives: Drug: VX-150; Drug: Placebo |
| placebo, VX-150 | Experimental | Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2 Receives: Drug: VX-150; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index pain subscale score at Day 14
Measured: from baseline at Day 14
Secondary outcomes (7)
Proportion of subjects with ≥50% reduction in WOMAC pain subscale at Day 14
Measured: at Day 14
Change from baseline in total WOMAC score at Day 14
Measured: at Day 14
Use of rescue medications [to be obtained by electronic diary and questionnaire]
Measured: 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.
Measured: up to 12 weeks (duration of study)
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Cmax [maximum plasma concentrations]
Measured: Days 1,14 of each treatment periods
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Tmax [time to maximum plasma concentration]
Measured: 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]
Measured: Days 1,14,16,18 of each treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660424
- Sponsor's protocol ID
- VX15-150-101
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2015
- Last updated
- 30 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02660424
- Acronym / sponsor ID
- VX15-150-101
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of osteoarthritis pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX-150, placebo | Experimental | Drug: VX-150, Drug: PlaceboSequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2 |
| placebo, VX-150 | Experimental | Drug: VX-150, Drug: PlaceboSequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-150 | Drug | VX-150, placebo, placebo, VX-150 |
| Placebo | Drug | VX-150, placebo, placebo, VX-150 |
Primary outcome
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
7 secondary outcomes
Proportion of subjects with ≥50% reduction in WOMAC pain subscale at Day 14
Time frame: at Day 14
Change from baseline in total WOMAC score at Day 14
Time frame: 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)
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)
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Cmax [maximum plasma concentrations]
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-150 in people with Osteoarthritis, run by Vertex Pharmaceuticals Incorporated at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.