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

NCT02660424 | Completed Phase 2

• 1 other identifier: VX15-150-101
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  from baseline at Day 14

Secondary Outcomes (7)

• 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

Study Arms (2)

VX-150, placebo

EXPERIMENTAL

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

Drug: VX-150; Drug: Placebo

placebo, VX-150

EXPERIMENTAL

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

Drug: VX-150; Drug: Placebo

Interventions

VX-150 DRUG

VX-150, placebo; placebo, VX-150

Placebo DRUG

VX-150, placebo; placebo, VX-150

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (12)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Valparaiso, Indiana, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Bay City, Michigan, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Hartsdale, New York, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Danville, Virginia, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 21, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

US (12)