A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults With Active Systemic Lupus Erythematosus
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of BIIB059 in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of BIIB059 on disease activity in participants with SLE, to evaluate the long-term effect of BIIB059 in participants with SLE in maintaining low disease activity, to evaluate the effect of BIIB059 in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving BIIB059 treatment, to assess the impact of BIIB059 on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of BIIB059 on laboratory parameters, and to evaluate immunogenicity of BIIB059.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue BIIB059 or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BIIB059 Low Dose Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received BIIB059 low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive BIIB059 low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of BIIB059-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received BIIB059-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive BIIB059 low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2. |
Drug: BIIB059
Administered as specified in the treatment arm.
Drug: BIIB059-matching placebo
Administered as specified in the treatment arm.
|
| Experimental: BIIB059 High Dose Participants who are receiving background nonbiologic lupus SOC therapy and received BIIB059 high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive BIIB059 high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of BIIB059-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received BIIB059-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive BIIB059 high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2. |
Drug: BIIB059
Administered as specified in the treatment arm.
Drug: BIIB059-matching placebo
Administered as specified in the treatment arm.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Up to Week 180]
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.
- Number of Participants with Serious Adverse Events (SAEs) [Up to Week 180]
An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.
Secondary Outcome Measures
- Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response [Up to Week 180]
SRI-4 is a composite endpoint defined as the following: A reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score. No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit. No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) visual analog scale (VAS). No violation of protocol-specified medication rules
- Percentage of Participants who Achieved a Joint-50 Response [Up to Week 180]
Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
- Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response [Up to Week 180]
CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A. CLASI-70 is 70% of improvement from baseline in CLASI-A and CLASI-90 is 90% of improvement from baseline in CLASI-A.
- Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response [Up to Week 180]
BICLA is a composite endpoint defined as the following: BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at Baseline improved to B, C, or D and all of BILAG-2004 Grade B at Baseline improved to C or D. No BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 Grade A or greater than 1 new BILAG-2004 Grade B. No worsening in the SLEDAI-2K total score compared to baseline. No worsening from baseline in lupus disease activity defined by a <0.3-point increase on a 3-point PGA VAS. No violation of protocol-specified medication rules.
- Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate [Up to Week 156]
A severe flare is defined as any of the following: Change in SLEDAI instrument score to >12 New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000/mL, or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose, increase to >0.5 milligrams per kilograms per day (mg/kg/day) or hospitalization Increase in prednisone dose to >0.5 mg/kg/day New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity Hospitalization for SLE activity Increase in PGA score to >2.5
- Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) [Up to Week 180]
LLDAS is a composite endpoint defined as the following: Current prednisone (or its equivalent) dose ≤7.5 mg/day No new lupus disease activity compared with the previous assessment PGA VAS (scale 0-3) ≤1 SLEDAI-2K ≤ 4, with no activity in major organ system (renal, central nervous system, cardiopulmonary, vasculitis, and fever) and no hemolytic anemia or gastrointestinal activity. Well tolerated standard maintenance dose of immunosuppressant lupus therapy
- Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS [Up to Week 180]
LLDAS is a composite endpoint defined as the following: Current prednisone (or its equivalent) dose ≤ 7.5 mg/day. No new lupus disease activity compared with the previous assessment. PGA VAS (scale 0-3) ≤ 1. SLEDAI-2K ≤ 4, with no activity in major organ system (renal, central nervous system, cardiopulmonary, vasculitis, and fever) and no hemolytic anemia or gastrointestinal activity. Well tolerated standard maintenance dose of immunosuppressant lupus therapy.
- Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score [Up to Week 156]
SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage.
- Cumulative Exposure to OCS Over Time [Up to Week 156]
- Percentage of Participants With OCS ≤7.5 mg [Up to Week 156]
- Percentage of Participants With OCS ≤5 mg [Up to Week 156]
- Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score [Up to Week 156]
The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.
- Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score [Up to Week 156]
The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health).
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score [Up to Week 156]
The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
- Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score [Up to Week 156]
The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.
- Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score [Up to Week 156]
WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity.
- Change from Baseline in Patient Global Assessment (PtGA) Score [Up to Week 156]
The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question.
- Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters [Up to Week 180]
Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.
- Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECGs) Results [Up to Week 156]
- Number of Participants with Antibodies to BIIB059 [Up to Week 180]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52
Key Exclusion Criteria:
-
Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
-
Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period)
-
Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose
-
Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies
NOTE: Other inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Mesa | Arizona | United States | 85210 |
| 2 | Research Site | Beverly Hills | California | United States | 90211 |
| 3 | Research Site | La Jolla | California | United States | 92037 |
| 4 | Research Site | Los Alamitos | California | United States | 90720 |
| 5 | Research Site | Los Angeles | California | United States | 90033 |
| 6 | Research Site | Los Angeles | California | United States | 90048 |
| 7 | Research Site | Mission Hills | California | United States | 91345 |
| 8 | Research Site | Poway | California | United States | 92064 |
| 9 | Research Site | Upland | California | United States | 91786 |
| 10 | Research Site | Whittier | California | United States | 90606 |
| 11 | Research Site | Aurora | Colorado | United States | 80045 |
| 12 | Research Site | Washington | District of Columbia | United States | 20007-2113 |
| 13 | Research Site | Aventura | Florida | United States | 33180 |
| 14 | Research Site | Boca Raton | Florida | United States | 33486 |
| 15 | Research Site | Clearwater | Florida | United States | 33765 |
| 16 | Research Site | DeBary | Florida | United States | 32713 |
| 17 | Research Site | Fort Lauderdale | Florida | United States | 33309 |
| 18 | Research Site | Gainesville | Florida | United States | 32611 |
| 19 | Research Site | Hollywood | Florida | United States | 33024 |
| 20 | Research Site | Margate | Florida | United States | 33063 |
| 21 | Research Site | Miami | Florida | United States | 33136 |
| 22 | Research Site | Orlando | Florida | United States | 32806 |
| 23 | Research Site | Sun City Center | Florida | United States | 33573 |
| 24 | Research Site | Tampa | Florida | United States | 33606 |
| 25 | Research Site | Tampa | Florida | United States | 33613 |
| 26 | Research Site | Atlanta | Georgia | United States | 30303 |
| 27 | Research Site | Decatur | Georgia | United States | 30033 |
| 28 | Research Site | Gainesville | Georgia | United States | 30501 |
| 29 | Research Site | Chicago | Illinois | United States | 60607 |
| 30 | Research Site | Shreveport | Louisiana | United States | 71103 |
| 31 | Research Site | Boston | Massachusetts | United States | 02118 |
| 32 | Research Site | Worcester | Massachusetts | United States | 01605 |
| 33 | Research Site | Grand Blanc | Michigan | United States | 48439 |
| 34 | Research Site | Saint Louis | Missouri | United States | 63110 |
| 35 | Research Site | Saint Louis | Missouri | United States | 63117 |
| 36 | Research Site | Freehold | New Jersey | United States | 07728 |
| 37 | Research Site | Las Cruces | New Mexico | United States | 88011 |
| 38 | Research Site | Brooklyn | New York | United States | 11201 |
| 39 | Research Site | Rochester | New York | United States | 14642 |
| 40 | Research Site | Syracuse | New York | United States | 13210 |
| 41 | Research Site | Charlotte | North Carolina | United States | 28204 |
| 42 | Research Site | Charlotte | North Carolina | United States | 28210 |
| 43 | Research Site | Greensboro | North Carolina | United States | 27405 |
| 44 | Research Site | Wilmington | North Carolina | United States | 28401 |
| 45 | Research Site | Winston-Salem | North Carolina | United States | 27157 |
| 46 | Research Site | Cincinnati | Ohio | United States | 45219 |
| 47 | Research Site | Dayton | Ohio | United States | 45417 |
| 48 | Research Site | Middleburg Heights | Ohio | United States | 44130 |
| 49 | Research Site | Greenville | South Carolina | United States | 29601 |
| 50 | Research Site | Summerville | South Carolina | United States | 29486 |
| 51 | Research Site | Jackson | Tennessee | United States | 38305 |
| 52 | Research Site | Memphis | Tennessee | United States | 38119 |
| 53 | Research Site | Nashville | Tennessee | United States | 37232 |
| 54 | Research Site | Allen | Texas | United States | 75013 |
| 55 | Research Site | Austin | Texas | United States | 78745 |
| 56 | Research Site | Baytown | Texas | United States | 77521 |
| 57 | Research Site | Colleyville | Texas | United States | 14642 |
| 58 | Research Site | Fort Worth | Texas | United States | 76107 |
| 59 | Research Site | Houston | Texas | United States | 77089 |
| 60 | Research Site | Houston | Texas | United States | 77099 |
| 61 | Research Site | Mesquite | Texas | United States | 75150 |
| 62 | Research Site | San Antonio | Texas | United States | 78215 |
| 63 | Research Site | San Antonio | Texas | United States | 78229 |
| 64 | Research Site | The Woodlands | Texas | United States | 77382 |
| 65 | Research Site | Webster | Texas | United States | 77598 |
| 66 | Research Site | Seattle | Washington | United States | 98122 |
| 67 | Research Site | Seattle | Washington | United States | 98195 |
| 68 | Research Site | La Plata | Buenos Aires | Argentina | B1900AXI |
| 69 | Research Site | Mar del Plata | Buenos Aires | Argentina | B7600FYK |
| 70 | Research Site | Quilmes | Buenos Aires | Argentina | B1878GEG |
| 71 | Research Site | San Miguel | Buenos Aires | Argentina | B1663 |
| 72 | Research Site | San Miguel de Tucuman | Tucuman | Argentina | T4000AXL |
| 73 | Research Site | San Miguel de Tucuman | Tucuman | Argentina | T4000ICL |
| 74 | Research Site | Ciudad Autonoma Buenos Aires | Argentina | C1013AAB | |
| 75 | Research Site | Ciudad Autonoma Buenos Aires | Argentina | C1221ADC | |
| 76 | Research Site | Ciudad Autonoma Buenos Aires | Argentina | C1417 | |
| 77 | Research Site | Mendoza | Argentina | M5500 | |
| 78 | Research Site | San Juan | Argentina | 5400 | |
| 79 | Research Site | Camperdown | New South Wales | Australia | 2050 |
| 80 | Research Site | Box Hill | Victoria | Australia | 3128 |
| 81 | Research Site | Footscray | Victoria | Australia | 3011 |
| 82 | Research Site | Murdoch | Western Australia | Australia | 6150 |
| 83 | Research Site | Leuven | Belgium | 3000 | |
| 84 | Research Site | Liege | Belgium | 4000 | |
| 85 | Research Site | Salvador | Bahia | Brazil | 40150-150 |
| 86 | Research Site | Fortaleza | Ceará | Brazil | 60430-370 |
| 87 | Research Site | Brasilia | Distrito Federal | Brazil | 70200-730 |
| 88 | Research Site | Vitória | Espírito Santo | Brazil | 29055-450 |
| 89 | Research Site | Cuiabá | Mato Grosso | Brazil | 78043-142 |
| 90 | Research Site | Belo Horizonte | Minas Gerais | Brazil | 30150-221 |
| 91 | Research Site | Juiz de Fora | Minas Gerais | Brazil | 36010-570 |
| 92 | Research Site | Curitiba | Paraná | Brazil | 80030-110 |
| 93 | Research Site | Porto Alegre | Rio Grande Do Sul | Brazil | 90480-000 |
| 94 | Research Site | Campinas | Sao Paulo | Brazil | 13083-888 |
| 95 | Research Site | Sao Jose | Sao Paulo | Brazil | 15090-000 |
| 96 | Research Site | São Bernardo | Sao Paulo | Brazil | 09715-090 |
| 97 | Research Site | São Paulo | Sao Paulo | Brazil | 04266-010 |
| 98 | Research Site | Plovdiv | Bulgaria | 4000 | |
| 99 | Research Site | Plovdiv | Bulgaria | 4002 | |
| 100 | Research Site | Plovdiv | Bulgaria | 4003 | |
| 101 | Research Site | Ruse | Bulgaria | 7002 | |
| 102 | Research Site | Sofia | Bulgaria | 1431 | |
| 103 | Research Site | Sofia | Bulgaria | 1510 | |
| 104 | Research Site | Sofia | Bulgaria | 1606 | |
| 105 | Research Site | Sofia | Bulgaria | 1612 | |
| 106 | Research Site | Barrie | Ontario | Canada | L4M 6L2 |
| 107 | Research Site | Hamilton | Ontario | Canada | L8V 1C3 |
| 108 | Research Site | Toronto | Ontario | Canada | M5S1A1 |
| 109 | Research Site | Los Lagos | Chile | 5311092 | |
| 110 | Research Site | Santiago | Chile | 7500000 | |
| 111 | Research Site | Santiago | Chile | 7500010 | |
| 112 | Research Site | Santiago | Chile | 7500571 | |
| 113 | Research Site | Santiago | Chile | 7500588 | |
| 114 | Research Site | Santiago | Chile | 7500710 | |
| 115 | Research Site | Santiago | Chile | 7510186 | |
| 116 | Research Site | Beijing | Beijing | China | 100020 |
| 117 | Research Site | Beijing | Beijing | China | 100032 |
| 118 | Research Site | Guangzhou | Guangdong | China | 510630 |
| 119 | Research Site | Shenzhen | Guangdong | China | 518020 |
| 120 | Research Site | Haikou | Hainan | China | 570311 |
| 121 | Research Site | Wuhan | Hubei | China | 430022 |
| 122 | Research Site | Changsha | Hunan | China | 410008 |
| 123 | Research Site | Changsha | Hunan | China | 410011 |
| 124 | Research Site | ZhuZhou | Hunan | China | 412000 |
| 125 | Research Site | Jiujiang | Jiangxi | China | 332000 |
| 126 | Research Site | Nanchang | Jiangxi | China | 330006 |
| 127 | Research Site | Pingxiang | Jiangxi | China | 337055 |
| 128 | Research Site | Changchun | Jilin | China | 130021 |
| 129 | Research Site | Binzhou | Shandong | China | 256603 |
| 130 | Research Site | Shanghai | Shanghai | China | 200001 |
| 131 | Research Site | Shanghai | Shanghai | China | 200011 |
| 132 | Research Site | Tianjin | Tianjin | China | 300052 |
| 133 | Research Site | Urumqi | Xinjiang | China | 830001 |
| 134 | Research Site | Ningbo | Zhejiang | China | 315010 |
| 135 | Research Site | Taoyuan | China | 333 | |
| 136 | Research Site | Barranquilla | Colombia | 080020 | |
| 137 | Research Site | Bogotá | Colombia | 110221 | |
| 138 | Research Site | Bucaramanga | Colombia | 680003 | |
| 139 | Research Site | Chia | Colombia | 00000 | |
| 140 | Research Site | Zipaquirá | Colombia | 250252 | |
| 141 | Research Site | Brno | Czechia | 625 00 | |
| 142 | Research Site | Brno | Czechia | 638 00 | |
| 143 | Research Site | Olomouc | Czechia | 77520 | |
| 144 | Research Site | Bordeaux | Gironde | France | 33000 |
| 145 | Research Site | Montpellier Cedex 5 | Herault | France | 34295 |
| 146 | Research Site | Paris cedex 14 | Paris | France | 75679 |
| 147 | Research Site | Clermont-Ferrand cedex 1 | Puy De Dome | France | 63003 |
| 148 | Research Site | Muenchen | Bayern | Germany | 80336 |
| 149 | Research Site | Göttingen | Niedersachsen | Germany | 37075 |
| 150 | Research Site | Hannover | Niedersachsen | Germany | 30625 |
| 151 | Research Site | Koeln | Nordrhein Westfalen | Germany | 50937 |
| 152 | Research Site | Mainz | Rheinland Pfalz | Germany | 55131 |
| 153 | Research Site | Athens | Greece | 11527 | |
| 154 | Research Site | Athens | Greece | 12462 | |
| 155 | Research Site | Athens | Greece | 16673 | |
| 156 | Research Site | Budapest | Hungary | 1036 | |
| 157 | Research Site | Budapest | Hungary | 1097 | |
| 158 | Research Site | Gyula | Hungary | 5700 | |
| 159 | Research Site | Szekesfehervar | Hungary | 8000 | |
| 160 | Research Site | Veszprem | Hungary | 8200 | |
| 161 | Research Site | Haifa | Israel | 3109601 | |
| 162 | Research Site | Kfar- Sava | Israel | 4428164 | |
| 163 | Research Site | Petach-Tikva | Israel | 4941492 | |
| 164 | Research Site | Ramat Gan | Israel | 5262001 | |
| 165 | Research Site | Tel Aviv | Israel | 64239 | |
| 166 | Research Site | Rozzano | Milano | Italy | 20089 |
| 167 | Research Site | Scafati | Salerno | Italy | 84018 |
| 168 | Research Site | Brescia | Italy | 25123 | |
| 169 | Research Site | Milano | Italy | 20122 | |
| 170 | Research Site | Padova | Italy | 35100 | |
| 171 | Research Site | Pisa | Italy | 56100 | |
| 172 | Research Site | Roma | Italy | 00151 | |
| 173 | Research Site | Roma | Italy | 00155 | |
| 174 | Research Site | Roma | Italy | 00161 | |
| 175 | Research Site | Nagoya-shi | Aichi-Ken | Japan | 457-8510 |
| 176 | Research Site | Toyoake-shi | Aichi-Ken | Japan | 470-1192 |
| 177 | Research Site | Chiba-shi | Chiba-Ken | Japan | 260-8712 |
| 178 | Research Site | Narashino-shi | Chiba-Ken | Japan | 275-8580 |
| 179 | Research Site | Fukuoka-shi | Fukuoka-Ken | Japan | 810-8539 |
| 180 | Research Site | Fukuoka-shi | Fukuoka-Ken | Japan | 810-8563 |
| 181 | Research Site | Kitakyushu-shi | Fukuoka-Ken | Japan | 807-8556 |
| 182 | Research Site | Hiroshima-shi | Hiroshima-Ken | Japan | 734-8551 |
| 183 | Research Site | Sapporo-shi | Hokkaido | Japan | 060-0004 |
| 184 | Research Site | Himeji-shi | Hyogo-Ken | Japan | 670-8540 |
| 185 | Research Site | Kobe-shi | Hyogo-Ken | Japan | 650-0017 |
| 186 | Research Site | Kobe-shi | Hyogo-Ken | Japan | 650-0047 |
| 187 | Research Site | Kita-gun | Kagawa-Ken | Japan | 761-0793 |
| 188 | Research Site | Kawasaki-shi | Kanagawa-Ken | Japan | 216-8511 |
| 189 | Research Site | Sagamihara-shi | Kanagawa-Ken | Japan | 252-0375 |
| 190 | Research Site | Yokohama-shi | Kanagawa-Ken | Japan | 232-0024 |
| 191 | Research Site | Yokohama-shi | Kanagawa-Ken | Japan | 245-8575 |
| 192 | Research Site | Kumamoto-shi | Kumamoto-Ken | Japan | 861-8520 |
| 193 | Research Site | Sendai-shi | Miyagi-Ken | Japan | 980-8574 |
| 194 | Research Site | Nagasaki-shi | Nagasaki-Ken | Japan | 852-8501 |
| 195 | Research Site | Osaka-shi | Osaka-Fu | Japan | 530-8480 |
| 196 | Research Site | Osakasayama-shi | Osaka-Fu | Japan | 589-8511 |
| 197 | Research Site | Osaka | Osaka-Fu | Japan | 586-8521 |
| 198 | Research Site | Takatsuki-shi | Osaka-Fu | Japan | 569-8686 |
| 199 | Research Site | Iruma-gun | Saitama-Ken | Japan | 350-0495 |
| 200 | Research Site | Bunkyo-ku | Tokyo-To | Japan | 113-8519 |
| 201 | Research Site | Chuo-ku | Tokyo-To | Japan | 104-8560 |
| 202 | Research Site | Itabashi-ku | Tokyo-To | Japan | 173-8610 |
| 203 | Research Site | Meguro-ku | Tokyo-To | Japan | 153-8515 |
| 204 | Research Site | Ota-ku | Tokyo-To | Japan | 143-8541 |
| 205 | Research Site | Shinjuku-ku | Tokyo-To | Japan | 160-8582 |
| 206 | Research Site | Shinjuku-ku | Tokyo-To | Japan | 162-8655 |
| 207 | Research Site | Suwon | Gyeonggi-do | Korea, Republic of | 16499 |
| 208 | Research Site | Busan | Korea, Republic of | 49201 | |
| 209 | Research Site | Incheon | Korea, Republic of | 21565 | |
| 210 | Research Site | Seoul | Korea, Republic of | 04763 | |
| 211 | Research Site | Seoul | Korea, Republic of | 05030 | |
| 212 | Research Site | Seoul | Korea, Republic of | 05505 | |
| 213 | Research Site | Ciudad de México | Distrito Federal | Mexico | 06700 |
| 214 | Research Site | Mexico | Distrito Federal | Mexico | 03720 |
| 215 | Research Site | Mexico | Distrito Federal | Mexico | 14080 |
| 216 | Research Site | Guadalajara | Jalisco | Mexico | 44130 |
| 217 | Research Site | Guadalajara | Jalisco | Mexico | 44650 |
| 218 | Research Site | Cuernavaca | Morelos | Mexico | 62290 |
| 219 | Research Site | Monterrey | Nuevo León | Mexico | 64460 |
| 220 | Research Site | Merida | Yucatán | Mexico | 97000 |
| 221 | Research Site | Merida | Yucatán | Mexico | 97070 |
| 222 | Research Site | Chihuahua | Mexico | 31000 | |
| 223 | Research Site | Durango | Mexico | 34080 | |
| 224 | Research Site | Amsterdam | Netherlands | 1081 HV | |
| 225 | Research Site | Groningen | Netherlands | 9713 GZ | |
| 226 | Research Site | Maastricht | Netherlands | 6229 HX | |
| 227 | Research Site | Utrecht | Netherlands | 3584 CX | |
| 228 | Research Site | Arequipa | Peru | 40103 | |
| 229 | Research Site | Lima | Peru | LIMA 11 | |
| 230 | Research Site | Lima | Peru | LIMA 29 | |
| 231 | Research Site | Angeles City | Philippines | 2009 | |
| 232 | Research Site | Davao City | Philippines | 8000 | |
| 233 | Research Site | Iloilo City | Philippines | 5000 | |
| 234 | Research Site | Lipa City | Philippines | 4217 | |
| 235 | Research Site | Manila | Philippines | 1000 | |
| 236 | Research Site | Manila | Philippines | 1008 | |
| 237 | Research Site | Pasig City | Philippines | 1605 | |
| 238 | Research Site | Quezon City | Philippines | 1102 | |
| 239 | Research Site | Quezon City | Philippines | 1118 | |
| 240 | Research Site | Bialystok | Poland | 15-707 | |
| 241 | Research Site | Bydgoszcz | Poland | 85-168 | |
| 242 | Research Site | Bydgoszcz | Poland | 85-605 | |
| 243 | Research Site | Bytom | Poland | 41-902 | |
| 244 | Research Site | Krakow | Poland | 30-033 | |
| 245 | Research Site | Krakow | Poland | 30-510 | |
| 246 | Research Site | Kraków | Poland | 30-363 | |
| 247 | Research Site | Lublin | Poland | 20-607 | |
| 248 | Research Site | Malbork | Poland | 82-200 | |
| 249 | Research Site | Szczecin | Poland | 71-252 | |
| 250 | Research Site | Warszawa | Poland | 00-874 | |
| 251 | Research Site | Wroclaw | Poland | 53-224 | |
| 252 | Research Site | Caguas | Puerto Rico | 00725 | |
| 253 | Research Site | Brasov | Romania | 500283 | |
| 254 | Research Site | Bucuresti | Romania | 014461 | |
| 255 | Research Site | Cluj-Napoca | Romania | 400006 | |
| 256 | Research Site | Iasi | Romania | 700023 | |
| 257 | Research Site | Targu Mures | Romania | 540136 | |
| 258 | Research Site | Kemerovo | Russian Federation | 650070 | |
| 259 | Research Site | Moscow | Russian Federation | 105554 | |
| 260 | Research Site | Moscow | Russian Federation | 115522 | |
| 261 | Research Site | Orenburg | Russian Federation | 460018 | |
| 262 | Research Site | Saint Petersburg | Russian Federation | 190068 | |
| 263 | Research Site | Belgrade | Serbia | 11000 | |
| 264 | Research Site | Belgrade | Serbia | 11080 | |
| 265 | Research Site | Niska Banja | Serbia | 18205 | |
| 266 | Research Site | Santander | Castellón | Spain | 39008 |
| 267 | Research Site | Barcelona | Spain | 08035 | |
| 268 | Research Site | Granada | Spain | 18016 | |
| 269 | Research Site | Sevilla | Spain | 41009 | |
| 270 | Research Site | Sevilla | Spain | 41010 | |
| 271 | Research Site | Valencia | Spain | 46017 | |
| 272 | Research Site | Lund | Sweden | 22185 | |
| 273 | Research Site | Stockholm | Sweden | SE-171 76 | |
| 274 | Research Site | Uppsala | Sweden | 751 85 | |
| 275 | Research Site | Örebro | Sweden | 70185 | |
| 276 | Research Site | Kaohsiung | Taiwan | 833 | |
| 277 | Research Site | London | Greater London | United Kingdom | E11 1NR |
| 278 | Research Site | London | Greater London | United Kingdom | SE1 7EH |
| 279 | Research Site | Edinburgh | Lothian Region | United Kingdom | EH16 4SA |
| 280 | Research Site | Doncaster | South Yorkshire | United Kingdom | DN2 5LT |
| 281 | Research Site | Cannock | Staffordshire | United Kingdom | WS11 5XY |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 230LE306
- 2021-006378-22