FACT OA1: 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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03161093
Collaborator
Teva Pharmaceutical Industries, Ltd. (Industry)
3,307
139
4
48.3
23.8
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 17, 2017
Actual Primary Completion Date :
Sep 9, 2019
Actual Study Completion Date :
Aug 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fasinumab dosing regimen 1

Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral

Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Names:
  • REGN475
  • Drug: Naproxen-matching placebo
    Capsule

    Experimental: Fasinumab dosing regimen 2

    Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral

    Drug: Fasinumab
    Solution for injection in pre-filled syringe
    Other Names:
  • REGN475
  • Drug: Naproxen-matching placebo
    Capsule

    Experimental: Fasinumab-matching placebo and naproxen

    Drug: Naproxen
    Pharmaceutical form: Capsule

    Drug: Fasinumab-matching placebo
    Solution for injection in pre-filled syringe

    Experimental: Fasinumab-matching placebo and naproxen-matching placebo

    Drug: Fasinumab-matching placebo
    Solution for injection in pre-filled syringe

    Drug: Naproxen-matching placebo
    Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Change in the WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]

    2. Change in the WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]

    Secondary Outcome Measures

    1. Change in the Patient Global Assessment (PGA) scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]

    2. Percentage of patients treated with fasinumab, compared with that of patients 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]

    3. Change in WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 16]

    4. Change in WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 16]

    5. Change in WOMAC pain subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with placebo [Baseline to Week 44]

    6. Change in WOMAC physical function subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with placebo [Baseline to Week 44]

    7. Change in the PGA scores from baseline to week 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 44]

    8. Change in the PGA scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with naproxen [Baseline to Week 16]

    9. Change in WOMAC pain subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 44]

    10. Change in WOMAC physical function subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 44]

    11. Percentage of patients treated with fasinumab, compared with that of patients 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]

    12. Change in WOMAC pain subscale scores from baseline to the average score across weeks 4, 8, 12 and 16, in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 4, 8, 12 and 16]

    13. Change in WOMAC physical function subscale scores from baseline to the average score across weeks 4, 8, 12 and 16, in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 4, 8, 12 and 16]

    14. Change in WOMAC pain subscale scores from baseline to the average score across weeks 36, 40 and 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 36, 40 and 44]

    15. Change in WOMAC physical function subscale scores from baseline to the average score across weeks 36, 40 and 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 36, 40 and 44]

    16. Incidence of Adjudicated Arthropathy (AA) (as confirmed by adjudication) [Baseline to Week 52]

      Year 1

    17. Incidence of AA (as confirmed by adjudication) [Day 1 through week 104E (Extension)]

      Year 1 and Year 2

    18. Incidence of AA (as confirmed by adjudication) [First dose of study drug in Year 2 through week 104E]

      Year 2

    19. Incidence of Destructive Arthropathy (DA) (as confirmed by adjudication) [Baseline to Week 52]

      Year 1

    20. Incidence of DA (as confirmed by adjudication) [Day 1 through week 104E]

      Year 1 and Year 2

    21. Incidence of DA (as confirmed by adjudication) [First dose of study drug in Year 2 through week 104E]

      Year 2

    22. Incidence of Treatment Emergent Adverse Events (TEAEs) [Baseline to Week 52]

      Year 1

    23. Incidence of TEAEs [Day 1 through week 104E]

      Year 1 and Year 2

    24. Incidence of TEAEs [First dose of study drug in Year 2 through week 104E]

      Year 2

    25. Incidence of sympathetic nervous system dysfunction [Baseline to Week 52]

      Year 1

    26. Incidence of sympathetic nervous system dysfunction [Day 1 through week 104E]

      Year 1 and Year 2

    27. Incidence of sympathetic nervous system dysfunction [First dose of study drug in Year 2 through week 104E]

      Year 2

    28. Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [Baseline to Week 52]

      Year 1

    29. Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [Day 1 through week 104E]

      Year 1 and Year 2

    30. Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [First dose of study drug in Year 2 through week 104E]

      Year 2

    31. Incidence of all-cause joint replacement (JR) [Baseline to Week 52]

      Year 1

    32. Incidence of all-cause JR [Day 1 through week 104E]

      Year 1 and Year 2

    33. Incidence of all-cause JR [First dose of study drug in Year 2 through week 104E]

      Year 2

    34. Incidence of JRs at the telephone survey [52 weeks after last dose of study drug (week 100)]

      Patients who only completed Year 1

    35. Incidence of JRs at the telephone survey [52 weeks after last dose of study drug (week 152E)]

      Patients who completed Year 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria include, but are not limited to, the following:
    Year 1:
    1. Male and female patients, at least 18 years of age, at screening

    2. 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

    3. Moderate to severe pain in the index joint defined at both the screening and randomization visits

    4. 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)

    5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:

    6. Inadequate pain relief from acetaminophen/paracetamol AND

    7. 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

    8. Currently using a stable dose of NSAID.

    9. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment

    10. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period

    11. 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

    12. Willing to maintain current activity and exercise levels throughout the study

    13. 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

    14. Able to understand and complete study-related questionnaires

    Year 2:

    Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.

    1. Completed the treatment period of Year 1

    2. Did not permanently discontinue study drug during Year 1

    3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1

    4. Provide informed consent for Year 2

    5. Willing to continue to maintain current activity and exercise levels throughout Year 2

    Exclusion Criteria include, but are not limited to, the following:
    1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period

    2. 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

    3. 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

    4. Trauma to the index joint within 3 months prior to the screening visit

    5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening

    6. Patient is not a candidate for MRI

    7. 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

    8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy

    9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy

    10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications

    11. Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits

    12. 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

    13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits

    14. History of poorly controlled hypertension

    15. 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

    16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis & Rheumatology Research, PLLC Mesa Arizona United States 85210
    2 Arizona Research Center Phoenix Arizona United States 85053
    3 Tucson Orthopaedic Research Center Tucson Arizona United States 85712
    4 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
    5 Medvin Clinical Research Covina California United States 91722
    6 TriWest Research Associates, LLC El Cajon California United States 92020
    7 BioSolutions Clinical Research La Mesa California United States 91942
    8 Pacific Arthritis Care Center Los Angeles California United States 90045
    9 Artemis Institute for Clinical Research San Diego California United States 92103
    10 Artemis Clinical Research San Marcos California United States 92078
    11 Lynn Institute of Denver Aurora Colorado United States 80012
    12 Lynn Institute of the Rockies Colorado Springs Colorado United States 80920
    13 Panorama Orthopedics & Spine Center Golden Colorado United States 80401
    14 Arthritis and Rheumatic Disease Specialties Aventura Florida United States 33180
    15 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    16 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
    17 Sensible Healthcare Ocoee Florida United States 34761
    18 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
    19 Jewett Orthopaedic Clinic Orlando Florida United States 32825
    20 Lovelace Scientific Resources Venice Florida United States 34292
    21 Meridian Clinical Research Savannah Georgia United States 31406
    22 Advanced Clinical Research Meridian Idaho United States 83642
    23 Medex Healthcare Research, Inc. Chicago Illinois United States 60602
    24 Northwestern University Chicago Illinois United States 60611
    25 Healthcare Research Network II, LLC Flossmoor Illinois United States 60422
    26 Integrated Clinical Trial Services, Inc. West Des Moines Iowa United States 50265
    27 Klein & Associates, MD PA Cumberland Maryland United States 21502
    28 Klein & Associates, MD, PA Hagerstown Maryland United States 21740
    29 The Center for Rheumatology and Bone Research Wheaton Maryland United States 20902
    30 Clinical Pharmacology Study Group Worcester Massachusetts United States 01605
    31 The Center for Pharmaceutical Research Kansas City Missouri United States 64114
    32 Medex Healthcare Research, Inc. Saint Louis Missouri United States 63117
    33 Sundance Clinical Research, LLC Saint Louis Missouri United States 63141
    34 Physician Research Collaboration, LLC Lincoln Nebraska United States 68516
    35 Lovelace Scientific Resources, Inc. Albuquerque New Mexico United States 87108
    36 United Medical Associates Binghamton New York United States 13901
    37 Regional Clinical Research, Inc. Endwell New York United States 13760
    38 Medex Healthcare Research New York New York United States 10036
    39 Buffalo Rheumatology and Medicine, PLLC Orchard Park New York United States 14127
    40 Orchard Park Family Practice Orchard Park New York United States 14127
    41 PMG Research of Raleigh, LLC d/b/a PMG Research of Cary Cary North Carolina United States 27518
    42 DJL Clinical Research, PLLC Charlotte North Carolina United States 28210
    43 Hickory Family Practice Associates Hickory North Carolina United States 28601
    44 Peters Medical Research LLC High Point North Carolina United States 27262
    45 PMG Research of Salisbury, LLC Salisbury North Carolina United States 28144
    46 PMG Research of Winston-Salem, LLC Winston-Salem North Carolina United States 27103
    47 Sterling Research Group, Ltd. Cincinnati Ohio United States 45219
    48 Hillcrest Clinical Research Oklahoma City Oklahoma United States 73119
    49 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    50 Low Country Rheumatology, PA Charleston South Carolina United States 29406
    51 PMG Research of Charleston, LLC Mount Pleasant South Carolina United States 29464
    52 Clinical Research Solutions Franklin Tennessee United States 37067
    53 PMG Research of Knoxville Knoxville Tennessee United States 37912
    54 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
    55 Pioneer Research Solutions, Inc. Cypress Texas United States 77429
    56 Southwest Rheumatology Research, LLC Mesquite Texas United States 75150
    57 Center for Arthritis and Rheumatic Diseases Chesapeake Virginia United States 23320
    58 Rheumatology & Pulmonary Clinic Beckley West Virginia United States 25801
    59 CCBR Vejle Vejle Denmark DK 7100
    60 Synexus Clinical Research GmbH Leipzig Sachsen Germany 04103
    61 Synexus Clinical Research GmbH Berlin Germany 12627
    62 Synexus Clinical Research GmbH Bochum Germany 44787
    63 Synexus Clinical Research GmbH Frankfurt Germany 60313
    64 Qualiclinic Kft. Budapest Hungary 1036
    65 Synexus Magyarorszag Kft Budapest Hungary 1036
    66 Synexus Magyarorszag Kft. Debrecen Hungary 4025
    67 Synexus Magyarorszag Kft. Gyula Hungary 5700
    68 BKS Research Kft. Hatvan Hungary 3000
    69 Hevizgyogyfurdo es Szent Andraes ReumaKorhaz Hévíz Hungary 8380
    70 Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly Nyíregyháza Hungary 4400
    71 Synexus Magyarorszag Egeszsegugyi Kft. Zalaegerszeg Hungary 8900
    72 Hospital of Lithuanian University of Health Sciences Kaunas Clinics Kaunas Lithuania LT35144
    73 Saules Seimos Medicinos Centras, Jsc Kaunas Lithuania LT50009
    74 Republican Panevezys Hospital Panevėžys Lithuania LT01117
    75 Center Outpation Clinic, Public Institution Vilnius Lithuania LT01117
    76 Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Wrocław Dolnoslaskie Poland 59-381
    77 Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy Łódź Lodzkie Poland 90-368
    78 Krakowskie Centrum Medyczne Sp. z o.o. Kraków Malopolskie Poland 31-501
    79 MCBK Sc lwona Czajkowska Monika Barney Grodzisk Mazowiecki Mazowieckie Poland 05-825
    80 Synexus Polska Sp. z o.o. Oddzial w Warszawie Warszawa Mazowieckie Poland 01-192
    81 Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Warszawa Mazowieckie Poland 04-730
    82 Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdynia Pomorskie Poland 81-537
    83 Synexus Polska Sp. z o.o. Oddzial w Gdyni Gdynia Pomorskie Poland 81-537
    84 Synexus Polska Sp. z o.o Oddzial w Poznaniu Poznań Wielkopolskie Poland 60-702
    85 ClinicMed Daniluk, Nowak Sp.j. Białystok Poland 15-879
    86 Synexus Polska Sp. z o.o. Oddzial w Katowicach Katowice Poland 40-040
    87 Malopolskie Centrum Kliniczne Kraków Poland 30-149
    88 CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa Skierniewice Poland 96-100
    89 Etg Zgierz Zgierz Poland 95-100
    90 Clinica Medicala Synexus Ltd. Bucharest Romania 021611
    91 SC Policlinica CCBR SRL Bucharest Romania 030463
    92 "SBEIHPE ""Kazan State Medical University"" of MHSD of Russia" Kazan Tatarstan Republic Russian Federation 420012
    93 "CDCR ""Healthy Joints"" L.L.C." Novosibirsk Russian Federation 630099
    94 City Out-Patient Clinic #109 Saint Petersburg Russian Federation 192263
    95 Samara Regional Clinical Hospital n.a.V.D.Seredavin Samara Russian Federation 443095
    96 "State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3""" Yaroslavl Russian Federation 150007
    97 Tread Research-Tygerberg Hospital Parow Cape Town South Africa 7500
    98 Welkom Clinical trial Centre Welkom Free State South Africa 9460
    99 Wits Clinical Research Johannesburg Gauteng South Africa 2013
    100 University of Pretoria Pretoria Gauteng South Africa 0002
    101 Global Clinical Trials Pretoria Gauteng South Africa 0083
    102 Synexus SA Stanza Clinical Research Centre Pretoria Gauteng South Africa 0122
    103 Synexus Watermeyer Clinical Research Centre Pretoria Gauteng South Africa 0184
    104 Roodepoort Medicross Clinical Research Centre Roodepoort Gauteng South Africa 1724
    105 Soweto Clinical Trials Centre (CTC) Soweto Johannesburg South Africa 1818
    106 Synapta Clinical Research Center Durban Kwa-Zulu Natal South Africa 4001
    107 Aliwal Shoal Medical Centre Umkomaas Kwa-Zulu Natal South Africa 4170
    108 Enhancing Care Durban KwaZulu-Natal South Africa 4091
    109 Mzansi Ethical Research Centre Middleburg Middelburg Mpumalanga South Africa 1055
    110 Langeberg Medicross Medical Centre Kraaifontein Western Cape South Africa 7570
    111 Paarl Research Centre Paarl Western Cape South Africa 7646
    112 Synexus Helderberg Clinical Trial Centre Somerset West Western Cape South Africa 7130
    113 TASK Applied Science Cape Town South Africa 7530
    114 Mzansi Ethical Research Centre Cape Town Cape Town South Africa 7764
    115 Newtown Clinical Research Johannesburg South Africa 2113
    116 CETA Leganes Leganés Madrid Spain 28915
    117 Complejo Hospitalario Universitario A Coruna A Coruña Spain 15006
    118 MeDiNova Investigacion y Desarrollo Madrid Spain 28100
    119 Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec Santiago De Compostela Spain 15705
    120 Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE) Sevilla Spain 41003
    121 Hospital Quiron Salud Infanta Luisa Sevilla Spain 41010
    122 "Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council""" Cherkasy Ukraine 18009
    123 Kharkiv City Multispecialty Hospital #18 Kharkiv Ukraine 61029
    124 Medical center of Private High Educational Institute Institute of General Practice-Family Medicine Kyiv Ukraine 02002
    125 "Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud""" Kyiv Ukraine 03037
    126 "Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway""" Kyiv Ukraine 03049
    127 Lviv Regional Hospital for veterans of the war and former political prisoners Lviv Ukraine 79495
    128 Synexus Thames Valley Clinical Research Centre Reading Berkshire United Kingdom RG2 0TG
    129 Synexus Scotland Clinical Research Centre Glasgow Lanarkshire United Kingdom G20 0SP
    130 Synexus Lancashire Clinical Research Centre Chorley Lancashire United Kingdom PR7 7NA
    131 MediNova North London Dedicated Research Centre, Mount Vernon Hospital Northwood Middlesex United Kingdom HA6 2RN
    132 Synexus North East Clinical Research Centre - Hexham General Hospital Hexham Northumberland United Kingdom NE46 1QJ
    133 Synexus Midlands Clinical Research Centre Birmingham West Midlands United Kingdom B15 2SQ
    134 Synexus Wales Clinical Research Centre Cardiff United Kingdom CF15 9SS
    135 Synexus Merseyside Clinical Research Centre Liverpool United Kingdom L22 0LG
    136 Synexus Manchester Clinical Research Centre-Manchester Science Park Manchester United Kingdom M15 6SX
    137 Medinova Research East London Clinical Studies Centre Romford United Kingdom RM1 3PJ
    138 MeDiNova Research Yorkshire Clinical Studies Centre Shipley United Kingdom BD18 3SA
    139 MediNova South London Dedicated Research Centre Sidcup United Kingdom DA14 6LT

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Teva Pharmaceutical Industries, Ltd.

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03161093
    Other Study ID Numbers:
    • R475-OA-1611
    • 2016-005020-29
    First Posted:
    May 19, 2017
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021