A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
FACT OA1
A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
2 other identifiers
interventional
3,307
12 countries
139
Brief Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are:
- 1.To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
- 2.To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
- 3.To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
- 4.To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
- 5.To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
- 6.To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
- 7.To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
- 8.To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
- 9.To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
- 10.To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2017
Typical duration for phase_3
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedStudy Start
First participant enrolled
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2021
CompletedResults Posted
Study results publicly available
November 14, 2022
CompletedNovember 14, 2022
October 1, 2022
2.1 years
May 18, 2017
August 25, 2022
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Secondary Outcomes (45)
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Baseline to Week 16
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
Baseline to Week 16
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
Baseline to Week 44
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
Baseline to Week 16
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
Week 16
- +40 more secondary outcomes
Study Arms (4)
Fasinumab dosing regimen 1
EXPERIMENTALFasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral
Fasinumab dosing regimen 2
EXPERIMENTALFasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Fasinumab-matching placebo and naproxen
EXPERIMENTALFasinumab-matching placebo and naproxen-matching placebo
EXPERIMENTALInterventions
Solution for injection in pre-filled syringe
Solution for injection in pre-filled syringe
Capsule
Eligibility Criteria
You may qualify if:
- Year 1:
- Male and female patients, at least 18 years of age, at screening
- A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
- Moderate to severe pain in the index joint defined at both the screening and randomization visits
- Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
- A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:
- Inadequate pain relief from acetaminophen/paracetamol AND
- Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
- Currently using a stable dose of NSAID.
- Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
- Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
- Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
- Willing to maintain current activity and exercise levels throughout the study
- Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
- Able to understand and complete study-related questionnaires
- +7 more criteria
You may not qualify if:
- Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
- History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
- History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
- Trauma to the index joint within 3 months prior to the screening visit
- Signs or symptoms of carpal tunnel syndrome within 6 months of screening
- Patient is not a candidate for MRI
- Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
- History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
- History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
- History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
- Resting heart rate of \<50 beats per minute (bpm) or \>100 bpm at the screening or randomization visits
- History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
- History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
- History of poorly controlled hypertension
- Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Teva Pharmaceutical Industries, Ltd.collaborator
Study Sites (139)
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Tucson Orthopaedic Research Center
Tucson, Arizona, 85712, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Medvin Clinical Research
Covina, California, 91722, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
BioSolutions Clinical Research
La Mesa, California, 91942, United States
Pacific Arthritis Care Center
Los Angeles, California, 90045, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Artemis Clinical Research
San Marcos, California, 92078, United States
Lynn Institute of Denver
Aurora, Colorado, 80012, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80920, United States
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Jewett Orthopaedic Clinic
Orlando, Florida, 32825, United States
Lovelace Scientific Resources
Venice, Florida, 34292, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602, United States
Northwestern University
Chicago, Illinois, 60611, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Klein & Associates, MD PA
Cumberland, Maryland, 21502, United States
Klein & Associates, MD, PA
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108, United States
United Medical Associates
Binghamton, New York, 13901, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Medex Healthcare Research
New York, New York, 10036, United States
Buffalo Rheumatology and Medicine, PLLC
Orchard Park, New York, 14127, United States
Orchard Park Family Practice
Orchard Park, New York, 14127, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Hickory Family Practice Associates
Hickory, North Carolina, 28601, United States
Peters Medical Research LLC
High Point, North Carolina, 27262, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219, United States
Hillcrest Clinical Research
Oklahoma City, Oklahoma, 73119, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research Solutions
Franklin, Tennessee, 37067, United States
PMG Research of Knoxville
Knoxville, Tennessee, 37912, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, 77429, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Center for Arthritis and Rheumatic Diseases
Chesapeake, Virginia, 23320, United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801, United States
CCBR Vejle
Vejle, DK 7100, Denmark
Synexus Clinical Research GmbH
Leipzig, Saxony, 04103, Germany
Synexus Clinical Research GmbH
Berlin, 12627, Germany
Synexus Clinical Research GmbH
Bochum, 44787, Germany
Synexus Clinical Research GmbH
Frankfurt, 60313, Germany
Qualiclinic Kft.
Budapest, 1036, Hungary
Synexus Magyarorszag Kft
Budapest, 1036, Hungary
Synexus Magyarorszag Kft.
Debrecen, 4025, Hungary
Synexus Magyarorszag Kft.
Gyula, 5700, Hungary
BKS Research Kft.
Hatvan, 3000, Hungary
Hevizgyogyfurdo es Szent Andraes ReumaKorhaz
Hévíz, 8380, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly
Nyíregyháza, 4400, Hungary
Synexus Magyarorszag Egeszsegugyi Kft.
Zalaegerszeg, 8900, Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT35144, Lithuania
Saules Seimos Medicinos Centras, Jsc
Kaunas, LT50009, Lithuania
Republican Panevezys Hospital
Panevezys, LT01117, Lithuania
Center Outpation Clinic, Public Institution
Vilnius, LT01117, Lithuania
Synexus Polska Sp. z o.o Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 59-381, Poland
MCBK Sc lwona Czajkowska Monika Barney
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 01-192, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.
Warsaw, Masovian Voivodeship, 04-730, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdynia, Pomeranian Voivodeship, 81-537, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537, Poland
ClinicMed Daniluk, Nowak Sp.j.
Bialystok, 15-879, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040, Poland
Malopolskie Centrum Kliniczne
Krakow, 30-149, Poland
CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Skierniewice, 96-100, Poland
Etg Zgierz
Zgierz, 95-100, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy
Lodz, Łódź Voivodeship, 90-368, Poland
Clinica Medicala Synexus Ltd.
Bucharest, 021611, Romania
SC Policlinica CCBR SRL
Bucharest, 030463, Romania
"SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"
Kazan', Tatarstan Republic, 420012, Russia
"CDCR ""Healthy Joints"" L.L.C."
Novosibirsk, 630099, Russia
City Out-Patient Clinic #109
Saint Petersburg, 192263, Russia
Samara Regional Clinical Hospital n.a.V.D.Seredavin
Samara, 443095, Russia
"State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3"""
Yaroslavl, 150007, Russia
Tread Research-Tygerberg Hospital
Parow, Cape Town, 7500, South Africa
Welkom Clinical trial Centre
Welkom, Free State, 9460, South Africa
Wits Clinical Research
Johannesburg, Gauteng, 2013, South Africa
University of Pretoria
Pretoria, Gauteng, 0002, South Africa
Global Clinical Trials
Pretoria, Gauteng, 0083, South Africa
Synexus SA Stanza Clinical Research Centre
Pretoria, Gauteng, 0122, South Africa
Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, 0184, South Africa
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, 1724, South Africa
Soweto Clinical Trials Centre (CTC)
Soweto, Johannesburg, 1818, South Africa
Synapta Clinical Research Center
Durban, KwaZulu-Natal, 4001, South Africa
Enhancing Care
Durban, KwaZulu-Natal, 4091, South Africa
Aliwal Shoal Medical Centre
eMkhomazi, KwaZulu-Natal, 4170, South Africa
Mzansi Ethical Research Centre Middleburg
Middelburg, Mpumalanga, 1055, South Africa
Langeberg Medicross Medical Centre
Kraaifontein, Western Cape, 7570, South Africa
Paarl Research Centre
Paarl, Western Cape, 7646, South Africa
Synexus Helderberg Clinical Trial Centre
Somerset West, Western Cape, 7130, South Africa
TASK Applied Science
Cape Town, 7530, South Africa
Mzansi Ethical Research Centre Cape Town
Cape Town, 7764, South Africa
Newtown Clinical Research
Johannesburg, 2113, South Africa
CETA Leganes
Leganés, Madrid, 28915, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
MeDiNova Investigacion y Desarrollo
Madrid, 28100, Spain
Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec
Santiago de Compostela, 15705, Spain
Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE)
Seville, 41003, Spain
Hospital Quiron Salud Infanta Luisa
Seville, 41010, Spain
"Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council"""
Cherkasy, 18009, Ukraine
Kharkiv City Multispecialty Hospital #18
Kharkiv, 61029, Ukraine
Medical center of Private High Educational Institute Institute of General Practice-Family Medicine
Kyiv, 02002, Ukraine
"Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud"""
Kyiv, 03037, Ukraine
"Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway"""
Kyiv, 03049, Ukraine
Lviv Regional Hospital for veterans of the war and former political prisoners
Lviv, 79495, Ukraine
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, RG2 0TG, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Lanarkshire, G20 0SP, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA, United Kingdom
MediNova North London Dedicated Research Centre, Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN, United Kingdom
Synexus North East Clinical Research Centre - Hexham General Hospital
Hexham, Northumberland, NE46 1QJ, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, West Midlands, B15 2SQ, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, L22 0LG, United Kingdom
Synexus Manchester Clinical Research Centre-Manchester Science Park
Manchester, M15 6SX, United Kingdom
Medinova Research East London Clinical Studies Centre
Romford, RM1 3PJ, United Kingdom
MeDiNova Research Yorkshire Clinical Studies Centre
Shipley, BD18 3SA, United Kingdom
MediNova South London Dedicated Research Centre
Sidcup, DA14 6LT, United Kingdom
Related Publications (1)
DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.
PMID: 41545313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2017
First Posted
May 19, 2017
Study Start
August 17, 2017
Primary Completion
September 9, 2019
Study Completion
August 27, 2021
Last Updated
November 14, 2022
Results First Posted
November 14, 2022
Record last verified: 2022-10