A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee

Sponsor

Vertex Pharmaceuticals Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT02660424

Collaborator

(none)

124

Enrollment

Locations

Arms

Duration (Months)

10.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of osteoarthritis pain

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: VX-150 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VX-150, placebo Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2	Drug: VX-150 Drug: Placebo
Experimental: placebo, VX-150 Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2	Drug: VX-150 Drug: Placebo

Arm

Intervention/Treatment

Experimental: VX-150, placebo

Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2

Drug: VX-150

Drug: Placebo

Experimental: placebo, VX-150

Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2

Drug: VX-150

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index pain subscale score at Day 14 [from baseline at Day 14]

Secondary Outcome Measures

Proportion of subjects with ≥50% reduction in WOMAC pain subscale at Day 14 [at Day 14]
Change from baseline in total WOMAC score at Day 14 [at Day 14]
Use of rescue medications [to be obtained by electronic diary and questionnaire] [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. [up to 12 weeks (duration of study)]
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Cmax [maximum plasma concentrations] [Days 1,14 of each treatment periods]
Plasma PK parameters of prodrug, VX-150 and its primary metabolite: Tmax [time to maximum plasma concentration] [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] [Days 1,14,16,18 of each treatment periods]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	San Diego	California	United States
2	West Palm Beach	Florida	United States
3	Marietta	Georgia	United States
4	Valparaiso	Indiana	United States
5	Wichita	Kansas	United States
6	Bay City	Michigan	United States
7	Las Vegas	Nevada	United States
8	Hartsdale	New York	United States
9	Duncansville	Pennsylvania	United States
10	Providence	Rhode Island	United States
11	Chattanooga	Tennessee	United States
12	Danville	Virginia	United States

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vertex Pharmaceuticals Incorporated

ClinicalTrials.gov Identifier:

NCT02660424

Other Study ID Numbers:

VX15-150-101

First Posted:

Jan 21, 2016

Last Update Posted:

Sep 30, 2020

Last Verified:

Sep 1, 2020

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 30, 2020