PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dapirolizumab pegol Subjects will receive dapriolizumab pegol througout the Treatment Period. |
Drug: DZP
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other Names:
|
| Placebo Comparator: Placebo Subjects will receive placebo througout the Treatment Period. |
Other: Placebo
Subjects will receive placebo at prespecified time-points.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Achievement of BICLA response at Week 48 [Week 48]
A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
Secondary Outcome Measures
- Achievement of BICLA response at Week 24 [Week 24]
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
- Achievement of BICLA response at Week 12 [Week 12]
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48 [During Treatment Period up to Week 48]
BILAG severe flare is defined as a British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A in any system due to individual items that are new or worse and are qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
- Achievement of LLDAS in ≥50% of post-Baseline visits through Week 48 [During Treatment Period up to Week 48]
Low lupus disease activity state (LLDAS) is defined as: No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever) No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit PGA ≤33mm Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5mg per day Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol
- Change from Baseline in SLEDAI-2K at Week 48 [From Baseline (Day 1) to Week 48]
The SLEDAI-2K Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K; 30 days) measures disease activity. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The total score falls between 0 and 105, with higher scores representing increased disease activity.
- Achievement of BILAG improvement without worsening at Week 48 [Week 48]
BILAG 2004 improvement without worsening can be defined as A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.
- Change from Baseline in PGA at Week 48 [From Baseline (Day 1) to Week 48]
Physician's Global Assessment of Disease (PGA) The Investigator will rate the overall status of the study participant.
- Achievement of SRI4 response at Week 48 [Week 48]
The Systemic Lupus Erythematosus Responder Index (SRI)-4 define responders as (ie, all criteria must be met): Reduction in SLEDAI-2K score of ≥4 No shift from BILAG 2004 Grade B, C, D, or E to A post-Baseline No more than 1 shift from BILAG 2004 Grade C, D, or E to B post-Baseline No worsening in the PGA compared to study entry defined as ≤10mm increase on a 100mm visual analog scale
- Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48 [During Treatment Period up to Week 48]
BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse and are qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010). BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse and are qualifying for the Grade B in any system (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG- 2004 index (Yee et al, 2010)
- Time to severe BILAG Flare through Week 48 [During Treatment Period up to Week 48]
BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse and are qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
- Time to moderate/severe BILAG flare through Week 48 [During Treatment Period up to Week 48]
BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse and are qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010). BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse and are qualifying for the Grade B in any system (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG- 2004 index (Yee et al, 2010)
- Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 54)]
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
- Percentage of participants with serious treatment-emergent adverse events during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 54)]
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
- Percentage of participants with treatment-emergent adverse events of special interest during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 54)]
An adverse event of special interest is any AE that a regulatory authority has mandated be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound.
- Percentage of participants with treatment-emergent adverse events of special monitoring during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 54)]
An adverse event of special monitoring is a product-specific AEs, adverse reactions, or safety topics considered as requiring special monitoring by UCB.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
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Study participant must be ≥16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
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Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:
- Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d (where available) as measured by central laboratory
- Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
- Anti-Smith (anti-Sm) antibodies (central laboratory) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historic evidence for anti-dsDNA antibodies
- Moderately to severely active defined as
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British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND
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Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at Screening Visit AND
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SLEDAI-2K without labs ≥4 at Baseline Visit
- Receiving the following SOC medication at stable dose:
- Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
Exclusion Criteria:
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Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life threatening condition
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Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
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Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
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Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
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Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
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Study participant had a reactivated latent infection (example, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2), or is currently receiving suppressive therapy for an opportunistic infection
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Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
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Study participant has clinically significant active or latent infection
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Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
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Study participant takes any protocol defined prohibited concomitant medication
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Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
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Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP
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Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate <30mL/min/1.73m^2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sl0043 50140 | Birmingham | Alabama | United States | 35205 |
| 2 | Sl0043 50052 | Phoenix | Arizona | United States | 85032 |
| 3 | Sl0043 50328 | Tucson | Arizona | United States | 85704 |
| 4 | Sl0043 50383 | Beverly Hills | California | United States | 90211 |
| 5 | Sl0043 50257 | La Jolla | California | United States | 92037 |
| 6 | Sl0043 50275 | La Palma | California | United States | 90623-1730 |
| 7 | Sl0043 50258 | Los Angeles | California | United States | 90022 |
| 8 | Sl0043 50276 | Los Angeles | California | United States | 90027 |
| 9 | Sl0043 50340 | Orange | California | United States | 92868 |
| 10 | Sl0043 50331 | Poway | California | United States | 92064 |
| 11 | Sl0043 50377 | San Diego | California | United States | 92108 |
| 12 | Sl0043 50320 | San Diego | California | United States | 92123 |
| 13 | Sl0043 50316 | San Leandro | California | United States | 94578 |
| 14 | Sl0043 50004 | Tustin | California | United States | 92780 |
| 15 | Sl0043 50409 | West Hills | California | United States | 91307 |
| 16 | Sl0043 50339 | Denver | Colorado | United States | 80230 |
| 17 | Sl0043 50367 | New Haven | Connecticut | United States | 06519 |
| 18 | Sl0043 50341 | Washington | District of Columbia | United States | 20060 |
| 19 | Sl0043 50460 | Aventura | Florida | United States | 33180 |
| 20 | Sl0043 50239 | Brandon | Florida | United States | 33511 |
| 21 | Sl0043 50362 | Gainesville | Florida | United States | 32610 |
| 22 | Sl0043 50122 | Miami | Florida | United States | 33136 |
| 23 | Sl0043 50325 | Miami | Florida | United States | 33173 |
| 24 | Sl0043 50459 | Orlando | Florida | United States | 32806 |
| 25 | Sl0043 50059 | Ormond Beach | Florida | United States | 32174 |
| 26 | Sl0043 50324 | Plantation | Florida | United States | 33324 |
| 27 | Sl0043 50329 | Tampa | Florida | United States | 33606 |
| 28 | Sl0043 50283 | Tampa | Florida | United States | 33613 |
| 29 | Sl0043 50368 | Atlanta | Georgia | United States | 30303 |
| 30 | Sl0043 50382 | Atlanta | Georgia | United States | 30309 |
| 31 | Sl0043 50260 | Decatur | Georgia | United States | 30033 |
| 32 | Sl0043 50240 | Idaho Falls | Idaho | United States | 83404 |
| 33 | Sl0043 50310 | Chicago | Illinois | United States | 60612 |
| 34 | Sl0043 50360 | Skokie | Illinois | United States | 60076 |
| 35 | Sl0043 50282 | Bowling Green | Kentucky | United States | 42101 |
| 36 | Sl0043 50474 | Hopkinsville | Kentucky | United States | 42240-1746 |
| 37 | Sl0043 50285 | Lake Charles | Louisiana | United States | 70605 |
| 38 | Sl0043 50288 | Cumberland | Maryland | United States | 21502 |
| 39 | Sl0043 50015 | Hagerstown | Maryland | United States | 21740 |
| 40 | Sl0043 50219 | Detroit | Michigan | United States | 48201 |
| 41 | Sl0043 50333 | Grand Blanc | Michigan | United States | 48439 |
| 42 | Sl0043 50104 | Rochester | Minnesota | United States | 55905 |
| 43 | Sl0043 50273 | Las Vegas | Nevada | United States | 89128 |
| 44 | Sl0043 50254 | Bronx | New York | United States | 10457 |
| 45 | Sl0043 50010 | Brooklyn | New York | United States | 11201 |
| 46 | Sl0043 50366 | Canton | New York | United States | 13617 |
| 47 | Sl0043 50266 | Great Neck | New York | United States | 11021 |
| 48 | Sl0043 50264 | Manhasset | New York | United States | 11030 |
| 49 | Sl0043 50077 | New York | New York | United States | 10021 |
| 50 | Sl0043 50334 | New York | New York | United States | 10032 |
| 51 | Sl0043 50241 | Syracuse | New York | United States | 13210 |
| 52 | Sl0043 50238 | Charlotte | North Carolina | United States | 28210 |
| 53 | Sl0043 50314 | Durham | North Carolina | United States | 27710 |
| 54 | Sl0043 50179 | Winston-Salem | North Carolina | United States | 27157-1010 |
| 55 | Sl0043 50330 | Cincinnati | Ohio | United States | 45242 |
| 56 | Sl0043 50255 | Columbus | Ohio | United States | 43203 |
| 57 | Sl0043 50322 | Oklahoma City | Oklahoma | United States | 73101 |
| 58 | Sl0043 50262 | Oklahoma City | Oklahoma | United States | 73104 |
| 59 | Sl0043 50020 | Duncansville | Pennsylvania | United States | 16635 |
| 60 | Sl0043 50147 | Hershey | Pennsylvania | United States | 17033 |
| 61 | Sl0043 50363 | Philadelphia | Pennsylvania | United States | 19104 |
| 62 | Sl0043 50364 | Philadelphia | Pennsylvania | United States | 19107 |
| 63 | Sl0043 50365 | Pittsburgh | Pennsylvania | United States | 15232 |
| 64 | Sl0043 50001 | Jackson | Tennessee | United States | 38305 |
| 65 | Sl0043 50263 | Amarillo | Texas | United States | 79124 |
| 66 | Sl0043 50338 | Bellaire | Texas | United States | 77401 |
| 67 | Sl0043 50418 | Colleyville | Texas | United States | 76034 |
| 68 | Sl0043 50057 | Dallas | Texas | United States | 75231 |
| 69 | Sl0043 50304 | Dallas | Texas | United States | 75390 |
| 70 | Sl0043 50036 | Mesquite | Texas | United States | 75150 |
| 71 | Sl0043 50027 | Seattle | Washington | United States | 98122 |
| 72 | Sl0043 50267 | Seattle | Washington | United States | 98195 |
| 73 | Sl0043 50061 | Spokane | Washington | United States | 99204 |
| 74 | Sl0043 50050 | Beckley | West Virginia | United States | 25801 |
| 75 | Sl0043 50321 | Morgantown | West Virginia | United States | 26505 |
| 76 | Sl0043 60002 | Buenos Aires | Argentina | ||
| 77 | Sl0043 60004 | C.a.b.a | Argentina | ||
| 78 | Sl0043 60001 | Ciudad Autonoma de Buenos Aire | Argentina | ||
| 79 | Sl0043 60024 | Córdoba | Argentina | ||
| 80 | Sl0043 60029 | Mendoza | Argentina | ||
| 81 | Sl0043 60003 | Quilmes | Argentina | ||
| 82 | Sl0043 60022 | Quilmes | Argentina | ||
| 83 | Sl0043 60011 | San Juan | Argentina | ||
| 84 | Sl0043 60014 | Tucuman | Argentina | ||
| 85 | Sl0043 30020 | Parkville | Australia | ||
| 86 | Sl0043 30025 | St Albans | Australia | ||
| 87 | Sl0043 40388 | Graz | Austria | ||
| 88 | Sl0043 40362 | Linz | Austria | ||
| 89 | Sl0043 40387 | Wien | Austria | ||
| 90 | Sl0043 40123 | Bruxelles | Belgium | ||
| 91 | Sl0043 40511 | Bruxelles | Belgium | ||
| 92 | Sl0043 40060 | Liege | Belgium | ||
| 93 | Sl0043 40006 | Plovdiv | Bulgaria | ||
| 94 | Sl0043 40189 | Plovdiv | Bulgaria | ||
| 95 | Sl0043 40522 | Plovdiv | Bulgaria | ||
| 96 | Sl0043 40379 | Sofia | Bulgaria | ||
| 97 | Sl0043 40380 | Sofia | Bulgaria | ||
| 98 | Sl0043 50374 | Calgary | Canada | ||
| 99 | Sl0043 50337 | Edmonton Ab | Canada | ||
| 100 | Sl0043 50335 | Montreal | Canada | ||
| 101 | Sl0043 50259 | Rimouski | Canada | ||
| 102 | Sl0043 50045 | Toronto | Canada | ||
| 103 | Sl0043 50044 | Trois-rivieres | Canada | ||
| 104 | Sl0043 60021 | Providencia, Santiago | Chile | ||
| 105 | Sl0043 60015 | Santiago de Chile | Chile | ||
| 106 | Sl0043 60018 | Santiago | Chile | ||
| 107 | Sl0043 60030 | Santiago | Chile | ||
| 108 | Sl0043 60013 | Barranquilla | Colombia | ||
| 109 | Sl0043 60019 | Barranquilla | Colombia | ||
| 110 | Sl0043 60006 | Bogota | Colombia | ||
| 111 | Sl0043 60027 | Bogota | Colombia | ||
| 112 | Sl0043 60016 | Bucaramanga | Colombia | ||
| 113 | Sl0043 60007 | Chia | Colombia | ||
| 114 | Sl0043 60031 | Monteria | Colombia | ||
| 115 | Sl0043 40066 | Praha 2 | Czechia | ||
| 116 | Sl0043 40124 | Praha 2 | Czechia | ||
| 117 | Sl0043 40518 | Bordeaux Cedex | France | ||
| 118 | Sl0043 40523 | Bordeaux | France | ||
| 119 | Sl0043 40506 | Montpellier | France | ||
| 120 | Sl0043 40505 | Paris Cedex 12 | France | ||
| 121 | Sl0043 40131 | Strasbourg | France | ||
| 122 | Sl0043 40463 | Berlin | Germany | ||
| 123 | Sl0043 40386 | Cologne | Germany | ||
| 124 | Sl0043 40322 | Dessau | Germany | ||
| 125 | Sl0043 40356 | Dresden | Germany | ||
| 126 | Sl0043 40462 | Frankfurt | Germany | ||
| 127 | Sl0043 40072 | Freiburg | Germany | ||
| 128 | Sl0043 40024 | Hanover | Germany | ||
| 129 | Sl0043 40027 | Herne | Germany | ||
| 130 | Sl0043 40078 | Leipzig | Germany | ||
| 131 | Sl0043 40174 | Mainz | Germany | ||
| 132 | Sl0043 40402 | Tübingen | Germany | ||
| 133 | Sl0043 40376 | Athens | Greece | ||
| 134 | Sl0043 40378 | Athens | Greece | ||
| 135 | Sl0043 40501 | Athens | Greece | ||
| 136 | Sl0043 40377 | Crete | Greece | ||
| 137 | Sl0043 40507 | Larisa | Greece | ||
| 138 | Sl0043 40488 | Patras | Greece | ||
| 139 | Sl0043 40375 | Thessaloniki | Greece | ||
| 140 | Sl0043 20102 | Shatin | Hong Kong | ||
| 141 | Sl0043 40412 | Budapest | Hungary | ||
| 142 | Sl0043 40411 | Debrecen | Hungary | ||
| 143 | Sl0043 40413 | Gyula | Hungary | ||
| 144 | Sl0043 40414 | Pecs | Hungary | ||
| 145 | Sl0043 40031 | Szeged | Hungary | ||
| 146 | Sl0043 40410 | Szeged | Hungary | ||
| 147 | Sl0043 40499 | Szekesfehervar | Hungary | ||
| 148 | Sl0043 40084 | Catania | Italy | ||
| 149 | Sl0043 40472 | Ferrara | Italy | ||
| 150 | Sl0043 40514 | Genova | Italy | ||
| 151 | Sl0043 40291 | Milano | Italy | ||
| 152 | Sl0043 40448 | Milano | Italy | ||
| 153 | Sl0043 40471 | Milano | Italy | ||
| 154 | Sl0043 40509 | Padova | Italy | ||
| 155 | Sl0043 40148 | Roma | Italy | ||
| 156 | Sl0043 40492 | Rozzano | Italy | ||
| 157 | Sl0043 40473 | Verona | Italy | ||
| 158 | Sl0043 20141 | Busan | Korea, Republic of | ||
| 159 | Sl0043 20106 | Daejeon | Korea, Republic of | ||
| 160 | Sl0043 20108 | Incheon | Korea, Republic of | ||
| 161 | Sl0043 20198 | Je-ju | Korea, Republic of | ||
| 162 | Sl0043 20104 | Seoul | Korea, Republic of | ||
| 163 | Sl0043 20138 | Seoul | Korea, Republic of | ||
| 164 | Sl0043 20092 | Suwon | Korea, Republic of | ||
| 165 | Sl0043 20107 | Yeongdeungpo-gu | Korea, Republic of | ||
| 166 | Sl0043 50317 | Chihuahua | Mexico | ||
| 167 | Sl0043 50250 | Cuernavaca | Mexico | ||
| 168 | Sl0043 50249 | Guadalajara | Mexico | ||
| 169 | Sl0043 50271 | Leon | Mexico | ||
| 170 | Sl0043 50252 | Merida | Mexico | ||
| 171 | Sl0043 50251 | Monterrey | Mexico | ||
| 172 | Sl0043 60026 | Arequipa | Peru | ||
| 173 | Sl0043 60008 | Lima | Peru | ||
| 174 | Sl0043 60009 | Lima | Peru | ||
| 175 | Sl0043 60023 | Lima | Peru | ||
| 176 | Sl0043 60020 | Miraflores, LIMA | Peru | ||
| 177 | Sl0043 20110 | Angeles | Philippines | ||
| 178 | Sl0043 20182 | Davao | Philippines | ||
| 179 | Sl0043 20109 | Iloilo | Philippines | ||
| 180 | Sl0043 20181 | Makati City | Philippines | ||
| 181 | Sl0043 20111 | Manila | Philippines | ||
| 182 | Sl0043 40482 | Bialystok | Poland | ||
| 183 | Sl0043 40119 | Bydgoszcz | Poland | ||
| 184 | Sl0043 40398 | Katowice | Poland | ||
| 185 | Sl0043 40490 | Krakow | Poland | ||
| 186 | Sl0043 40502 | Krakow | Poland | ||
| 187 | Sl0043 40037 | Lublin | Poland | ||
| 188 | Sl0043 40151 | Lublin | Poland | ||
| 189 | Sl0043 40483 | Nadarzyn | Poland | ||
| 190 | Sl0043 40044 | Poznan | Poland | ||
| 191 | Sl0043 40090 | Poznan | Poland | ||
| 192 | Sl0043 40484 | Poznan | Poland | ||
| 193 | Sl0043 40396 | Rzeszow | Poland | ||
| 194 | Sl0043 40097 | Warszawa | Poland | ||
| 195 | Sl0043 40098 | Warszawa | Poland | ||
| 196 | Sl0043 40394 | Warszawa | Poland | ||
| 197 | Sl0043 40397 | Wroclaw | Poland | ||
| 198 | Sl0043 40481 | Wroclaw | Poland | ||
| 199 | Sl0043 40485 | Coimbra | Portugal | ||
| 200 | Sl0043 40417 | Leiria | Portugal | ||
| 201 | Sl0043 40491 | Lisboa | Portugal | ||
| 202 | Sl0043 40416 | Ponte de Lima | Portugal | ||
| 203 | Sl0043 40415 | Vila Nova de Gaia | Portugal | ||
| 204 | Sl0043 40464 | Bucharest | Romania | ||
| 205 | Sl0043 40383 | Bucuresti | Romania | ||
| 206 | Sl0043 40382 | Galati | Romania | ||
| 207 | Sl0043 40393 | Belgrade | Serbia | ||
| 208 | Sl0043 40461 | Belgrade | Serbia | ||
| 209 | Sl0043 40466 | Kragujevac | Serbia | ||
| 210 | Sl0043 40392 | Novi Sad | Serbia | ||
| 211 | Sl0043 40045 | A Coruna | Spain | ||
| 212 | Sl0043 40160 | Barcelona | Spain | ||
| 213 | Sl0043 40294 | Las Palmas de Gran Canaria | Spain | ||
| 214 | Sl0043 40399 | Murcia | Spain | ||
| 215 | Sl0043 40341 | Málaga | Spain | ||
| 216 | Sl0043 40521 | Mérida | Spain | ||
| 217 | Sl0043 40101 | Sabadell | Spain | ||
| 218 | Sl0043 40401 | San Cristóbal de La Laguna | Spain | ||
| 219 | Sl0043 40400 | Sevilla | Spain | ||
| 220 | Sl0043 40099 | Vigo | Spain | ||
| 221 | Sl0043 20096 | Changhua | Taiwan | ||
| 222 | Sl0043 20082 | Kwei-san Hsiang | Taiwan | ||
| 223 | Sl0043 20142 | Taichung City | Taiwan | ||
| 224 | Sl0043 20113 | Taichung | Taiwan | ||
| 225 | Sl0043 20086 | Taipei | Taiwan | ||
| 226 | Sl0043 20095 | Taipei | Taiwan | ||
| 227 | Sl0043 20099 | Taipei | Taiwan | ||
| 228 | Sl0043 20114 | Taipei | Taiwan | ||
| 229 | Sl0043 40469 | London | United Kingdom | ||
| 230 | Sl0043 40306 | Newcastle Upon Tyne | United Kingdom |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SL0043
- 2019-003406-27