Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
RIVER-AD
A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.
5 other identifiers
interventional
1,663
29 countries
378
Brief Summary
This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline. Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Longer than P75 for phase_2
378 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
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 22, 2029
May 5, 2026
May 1, 2026
6.4 years
August 5, 2022
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants who experienced treatment-emergent adverse event (TEAE)
Baseline to Week 332
Secondary Outcomes (29)
Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)
Baseline to Week 332
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)
Baseline to Week 332
Percentage of participants who experienced TEAE leading to treatment discontinuation
Baseline to Week 332
Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
DRI17366 Baseline to Week 332
Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
DRI17366 Baseline to Week 332
- +24 more secondary outcomes
Study Arms (2)
Amlitelimab dose level 1
EXPERIMENTALSubcutaneous injection as per protocol
Amlitelimab dose level 2
EXPERIMENTALSubcutaneous injection as per protocol
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Topical Route of administration: Topical
Pharmaceutical form: Topical Route of administration: Topical
Pharmaceutical form: Oral Route of administration: Oral
Eligibility Criteria
You may qualify if:
- Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
- Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.
- Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
- Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
- The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
- The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
- The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
- Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
- Complied with the previous clinical trial protocol to the satisfaction of the investigator
- Body weight must be ≥25 kg
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
- Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
- History of solid organ or stem cell transplant
- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
- Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
- History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening
- Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
- Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
- Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
- For whom review and approval from Sponsor have been granted are eligible
- Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
- Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (378)
Allervie Clinical Research - Birmingham- Site Number : 8401101
Birmingham, Alabama, 35209, United States
Cahaba Dermatology & Skin Health Center- Site Number : 8401066
Birmingham, Alabama, 35244, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, 85260, United States
Scottsdale Clinical Trials- Site Number : 8401149
Scottsdale, Arizona, 85260, United States
Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona, 85745, United States
Arkansas Research Trials- Site Number : 8401244
North Little Rock, Arkansas, 72217, United States
Orange County Clinical Trials- Site Number : 8401271
Anaheim, California, 92801, United States
Encino Research Center- Site Number : 8401042
Encino, California, 91436, United States
First OC Dermatology- Site Number : 8401025
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California, 94538, United States
Marvel Clinical Research- Site Number : 8401102
Huntington Beach, California, 92647, United States
Sunwise Clinical Research- Site Number : 8401022
Lafayette, California, 94549, United States
Antelope Valley Clinical Trials- Site Number : 8401099
Lancaster, California, 93534, United States
Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
Lomita, California, 90717, United States
Long Beach Clinical Trials- Site Number : 8401188
Long Beach, California, 90806, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, 90045, United States
LA Universal Research Center- Site Number : 8401064
Los Angeles, California, 90057, United States
Cura Clinical Research - Oxnard- Site Number : 8401142
Oxnard, California, 93030, United States
Southern California Dermatology- Site Number : 8401043
Santa Ana, California, 92701, United States
Clinical Science Institute- Site Number : 8401028
Santa Monica, California, 90404, United States
Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge, Colorado, 80033, United States
Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach, Florida, 33436, United States
Pediatric Skin Research- Site Number : 8401198
Coral Gables, Florida, 33146, United States
St. Jude Clinical Research- Site Number : 8401287
Doral, Florida, 33172, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
Fort Myers, Florida, 33912, United States
Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
Fort Myers, Florida, 33919, United States
Direct Helpers Research Center- Site Number : 8401056
Hialeah, Florida, 33012, United States
Doral Medical Research - Hialeah- Site Number : 8401094
Hialeah, Florida, 33016, United States
Apex Clinical Research - Jacksonville- Site Number : 8401332
Jacksonville, Florida, 32256, United States
Clever Medical Research- Site Number : 8401160
Miami, Florida, 33126, United States
Miami Dermatology and Laser Research - Miami - South Miami Avenue- Site Number : 8401086
Miami, Florida, 33133, United States
Medical Research Center of Miami II- Site Number : 8401019
Miami, Florida, 33134, United States
Acevedo Clinical Research Associates- Site Number : 8401088
Miami, Florida, 33142, United States
Future Care Solution - Miami- Site Number : 8401144
Miami, Florida, 33142, United States
Sanchez Clinical Research- Site Number : 8401095
Miami, Florida, 33157, United States
Florida International Research Center- Site Number : 8401091
Miami, Florida, 33173, United States
Savin Medical Group - Miami Lakes- Site Number : 8401085
Miami Lakes, Florida, 33014, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109
Miami Lakes, Florida, 33016, United States
K2 South Orlando - South Orange Avenue- Site Number : 8401268
Orlando, Florida, 32806, United States
Nuline Clinical Trial Center- Site Number : 8401161
Pompano Beach, Florida, 33060, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, Florida, 33705, United States
Clinical Research Trials of Florida- Site Number : 8401023
Tampa, Florida, 33607, United States
Alliance Clinical Research of Tampa- Site Number : 8401013
Tampa, Florida, 33615, United States
Cleaver Medical Group- Site Number : 8401138
Dawsonville, Georgia, 30534, United States
First Georgia Physician Group- Site Number : 8401190
Fayetteville, Georgia, 30214, United States
Aeroallergy Research Laboratory- Site Number : 8401004
Savannah, Georgia, 31406, United States
Javara Research - Thomasville- Site Number : 8401189
Thomasville, Georgia, 31792, United States
Northwestern University- Site Number : 8401038
Chicago, Illinois, 60611, United States
Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green, Kentucky, 42104, United States
Skin Sciences- Site Number : 8401039
Louisville, Kentucky, 40217, United States
Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072
Baton Rouge, Louisiana, 70809, United States
MedPharmics - Covington- Site Number : 8401137
Covington, Louisiana, 70433, United States
BRCR Global Gretna- Site Number : 8401243
Gretna, Louisiana, 70053, United States
Velocity Clinical Research - Lafayette- Site Number : 8401152
Lafayette, Louisiana, 70508, United States
MetroBoston Clinical Partners - Brighton- Site Number : 8401128
Brighton, Massachusetts, 02135, United States
Henry Ford Health System- Site Number : 8401044
Detroit, Michigan, 48202, United States
Revival Research Institute - Troy- Site Number : 8401012
Troy, Michigan, 48084, United States
Oakland Medical Center- Site Number : 8401116
Troy, Michigan, 48085, United States
Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
Ypsilanti, Michigan, 48197, United States
SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
Ridgeland, Mississippi, 39157, United States
Skin Specialists- Site Number : 8401068
Omaha, Nebraska, 68144, United States
Pulmonology Group - Henderson- Site Number : 8401169
Henderson, Nevada, 89052, United States
Jubilee Clinical Research- Site Number : 8401054
Las Vegas, Nevada, 89106, United States
Schweiger Dermatology Group - East Windsor- Site Number : 8401338
East Windsor, New Jersey, 08520, United States
Care Access - Hoboken- Site Number : 8401132
Hoboken, New Jersey, 07030, United States
The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico, 87106, United States
Equity Medical- Site Number : 8401239
New York, New York, 10023, United States
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York, 10075, United States
Skin Search Rochester- Site Number : 8401216
Rochester, New York, 14623, United States
AXIS Clinicals - Fargo- Site Number : 8401196
Fargo, North Dakota, 58103, United States
Oregon Health & Science University (OHSU)- Site Number : 8401247
Portland, Oregon, 97239, United States
Best Skin Research - Camp Hill- Site Number : 8401031
Camp Hill, Pennsylvania, 17011, United States
Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania, 19103, United States
Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania, 19114, United States
Dermatology Associates of Plymouth Meeting- Site Number : 8401147
Plymouth Meeting, Pennsylvania, 19462, United States
Velocity Clinical Research - Columbia- Site Number : 8401176
Columbia, South Carolina, 29204, United States
Columbia Dermatology & Aesthetics- Site Number : 8401166
Columbia, South Carolina, 29212, United States
Health Concepts - Site Number : 8401059
Rapid City, South Dakota, 57702, United States
Arlington Research Center- Site Number : 8401248
Arlington, Texas, 76011, United States
Dermatology Treatment and Research Center- Site Number : 8401164
Dallas, Texas, 75230, United States
Modern Research Associates- Site Number : 8401093
Dallas, Texas, 75231, United States
Reveal Research Institute - Dallas- Site Number : 8401219
Dallas, Texas, 75235, United States
Prolato Clinical Research Center- Site Number : 8401209
Houston, Texas, 77054, United States
SMS Clinical Research- Site Number : 8401182
Mesquite, Texas, 75149, United States
Synapse Clinical Research - Missouri City- Site Number : 8401148
Missouri City, Texas, 77459, United States
Stryde Research - Epiphany Dermatology- Site Number : 8401185
Southlake, Texas, 76092, United States
Complete Dermatology - Sugar Land- Site Number : 8401061
Sugar Land, Texas, 77479, United States
Tanner Clinic - Layton Antelope A- Site Number : 8401151
Layton, Utah, 84041, United States
Care Access - Arlington- Site Number : 8401134
Arlington, Virginia, 22206, United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, Virginia, 23502, United States
Wyoming Research Foundation- Site Number : 8401234
Cheyenne, Wyoming, 82001, United States
Investigational Site Number : 0320021
Berazategui, Buenos Aires, 1886, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320015
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320020
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Investigational Site Number : 0320022
Buenos Aires, 1012, Argentina
Investigational Site Number : 0320011
Buenos Aires, 1035, Argentina
Investigational Site Number : 0320016
Buenos Aires, 1055, Argentina
Investigational Site Number : 0320008
Buenos Aires, 1061, Argentina
Investigational Site Number : 0320001
Buenos Aires, 1121, Argentina
Investigational Site Number : 0320018
Buenos Aires, 1178, Argentina
Investigational Site Number : 0320010
Buenos Aires, 1414, Argentina
Investigational Site Number : 0320002
Buenos Aires, 1425, Argentina
Investigational Site Number : 0320004
Buenos Aires, 1425, Argentina
Investigational Site Number : 0320009
Buenos Aires, 1425, Argentina
Investigational Site Number : 0320019
Buenos Aires, 1426, Argentina
Investigational Site Number : 0320005
Buenos Aires, 1427, Argentina
Investigational Site Number : 0320012
Corrientes, 3400, Argentina
Investigational Site Number : 0320014
Córdoba, 5000, Argentina
Investigational Site Number : 0320013
Mendoza, 5500, Argentina
Investigational Site Number : 0360010
Westmead, New South Wales, 2145, Australia
Investigational Site Number : 0360007
Woolloongabba, Queensland, 4102, Australia
Investigational Site Number : 0363002
Carlton, Victoria, 3053, Australia
Investigational Site Number : 0363003
Melbourne, Victoria, 3002, Australia
Investigational Site Number : 0360006
Melbourne, Victoria, 3004, Australia
Investigational Site Number : 0363001
Parkville, Victoria, 3050, Australia
Investigational Site Number : 0361006
Traralgon, Victoria, 3844, Australia
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
Vitória, Espírito Santo, 29055-450, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia, 41820-020, Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
Curitiba, Paraná, 80230-130, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
Ribeirão Preto, São Paulo, 14049-900, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, São Paulo, 09060-650, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba, São Paulo, 18040-425, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018
Rio de Janeiro, 22241-180, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
São Paulo, 01323-020, Brazil
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
São Paulo, 04020-060, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012
São Paulo, 05403-000, Brazil
Investigational Site Number : 1002007
Dupnitsa, 2600, Bulgaria
Investigational Site Number : 1002004
Pleven, 5800, Bulgaria
Investigational Site Number : 1002005
Sofia, 1431, Bulgaria
Investigational Site Number : 1002003
Sofia, 1463, Bulgaria
Investigational Site Number : 1002006
Sofia, 1592, Bulgaria
Investigational Site Number : 1002002
Sofia, 1784, Bulgaria
Investigational Site Number : 1240039
Calgary, Alberta, T2J 7E1, Canada
Investigational Site Number : 1240019
Calgary, Alberta, T2W 4X9, Canada
Investigational Site Number : 1240023
Calgary, Alberta, T3A 2N1, Canada
Investigational Site Number : 1240016
Edmonton, Alberta, T5J 3S9, Canada
Investigational Site Number : 1240031
Edmonton, Alberta, T5K 2V4, Canada
Investigational Site Number : 1240045
Red Deer, Alberta, T4P 1K4, Canada
Investigational Site Number : 1240040
Surrey, British Columbia, V3R 6A7, Canada
Investigational Site Number : 1240030
Surrey, British Columbia, V3V 0C6, Canada
Investigational Site Number : 1240041
Winnipeg, Manitoba, R3M 3Z4, Canada
Investigational Site Number : 1240033
Ajax, Ontario, L1S 7K8, Canada
Investigational Site Number : 1240014
Barrie, Ontario, L4M 7G1, Canada
Investigational Site Number : 1240020
Hamilton, Ontario, L8L 3C3, Canada
Investigational Site Number : 1240029
London, Ontario, L6A 2C2, Canada
Investigational Site Number : 1240053
London, Ontario, N6A 5R9, Canada
Investigational Site Number : 1240017
London, Ontario, N6H 5L5, Canada
Investigational Site Number : 1241106
Markham, Ontario, L3P 1X2, Canada
Investigational Site Number : 1240018
Newmarket, Ontario, L3Y 9E5, Canada
Investigational Site Number : 1241108
Niagara Falls, Ontario, L2H 1H5, Canada
Investigational Site Number : 1240034
Ottawa, Ontario, K1K 4L2, Canada
Investigational Site Number : 1240024
Richmond Hill, Ontario, L4B 1A5, Canada
Investigational Site Number : 1240038
Richmond Hill, Ontario, L4E 4L6, Canada
Investigational Site Number : 1240021
Toronto, Ontario, M2N 3A6, Canada
Investigational Site Number : 1240012
Toronto, Ontario, M3H 5Y8, Canada
Investigational Site Number : 1240026
Toronto, Ontario, M4E 1R7, Canada
Investigational Site Number: 1240035
Toronto, Ontario, M5A 3R6, Canada
Investigational Site Number : 1241107
Waterloo, Ontario, N2J 1C4, Canada
Investigational Site Number : 1241101
Windsor, Ontario, N8W 1E6, Canada
Investigational Site Number : 1240006
Québec, Quebec, G1W 4R4, Canada
Investigational Site Number: 1240028
Regina, Saskatchewan, S4V 1R9, Canada
Investigational Site Number : 1240036
Saskatoon, Saskatchewan, S7K 0H6, Canada
Investigational Site Number : 1520012
Talcahuano, Biobio, 2687000, Chile
Investigational Site Number : 1520009
Osorno, Los Lagos Region, 5311523, Chile
Investigational Site Number : 1520004
Valdivia, Los Ríos Region, 5110683, Chile
Investigational Site Number : 1520013
Santiago, Reg Metropolitana de Santiago, 7500505, Chile
Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, 7500587, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7580206, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7640881, Chile
Investigational Site Number : 1520014
Santiago, Reg Metropolitana de Santiago, 7750495, Chile
Investigational Site Number : 1520010
Santiago, Reg Metropolitana de Santiago, 8330034, Chile
Investigational Site Number : 1520011
Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 8380465, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8420383, Chile
Investigational Site Number : 1520015
Quillota, Valparaiso, 2260877, Chile
Investigational Site Number : 1520006
Viña del Mar, Valparaiso, 2530900, Chile
Investigational Site Number : 1560042
Beijing, 100034, China
Investigational Site Number : 1560004
Beijing, 100191, China
Investigational Site Number : 1560030
Beijing, 100730, China
Investigational Site Number : 1560050
Changsha, 410011, China
Investigational Site Number : 1560022
Chengdu, 610041, China
Investigational Site Number : 1560060
Chengdu, 610072, China
Investigational Site Number : 1560057
Chongqing, 400016, China
Investigational Site Number : 1560043
Fuzhou, 350005, China
Investigational Site Number : 1560021
Guangzhou, 510018, China
Investigational Site Number : 1560025
Guangzhou, 510080, China
Investigational Site Number : 1560036
Guangzhou, 510100, China
Investigational Site Number : 1560058
Guangzhou, 510630, China
Investigational Site Number : 1560044
Hangzhou, 310003, China
Investigational Site Number : 1560002
Hangzhou, 310006, China
Investigational Site Number : 1560006
Hangzhou, 310009, China
Investigational Site Number : 1560029
Hangzhou, 310014, China
Investigational Site Number : 1560051
Nanchang, 330001, China
Investigational Site Number : 1560024
Ningbo, 315010, China
Investigational Site Number : 1560035
Ningbo, 315010, China
Investigational Site Number : 1560001
Shanghai, 200040, China
Investigational Site Number : 1560005
Shanghai, 200443, China
Investigational Site Number : 1560041
Shenyang, 110001, China
Investigational Site Number : 1560026
Shenyang, 110179, China
Investigational Site Number : 1560064
Shenzhen, 518026, China
Investigational Site Number : 1560023
Wenzhou, 325035, China
Investigational Site Number : 1560049
Wuhan, 430022, China
Investigational Site Number : 1560038
Wuhan, 430030, China
Investigational Site Number : 1560003
Wuxi, 214000, China
Investigational Site Number : 1560032
Xi'an, 710004, China
Investigational Site Number : 1560028
Zhenjiang, 212000, China
Investigational Site Number : 2032108
Brno, 602 00, Czechia
Investigational Site Number : 2032106
Kutná Hora, 284 01, Czechia
Investigational Site Number : 2032105
Nový Jičín, 741 01, Czechia
Investigational Site Number : 2030010
Olomouc, 779 00, Czechia
Investigational Site Number : 2032104
Ostrava, 702 00, Czechia
Investigational Site Number : 2030009
Pilsen, 323 00, Czechia
Investigational Site Number : 2032102
Prague, 100 00, Czechia
Investigational Site Number : 2030008
Prague, 110 00, Czechia
Investigational Site Number : 2032101
Prague, 120 00, Czechia
Investigational Site Number : 2032103
Prague, 130 00, Czechia
Investigational Site Number : 2030011
Prague, 150 00, Czechia
Investigational Site Number : 2030006
Prague, 160 00, Czechia
Investigational Site Number : 2080001
Aarhus, 8200, Denmark
Investigational Site Number : 2080003
Herlev, 2730, Denmark
Investigational Site Number : 2500008
Antony, 92160, France
Investigational Site Number : 2500011
Bordeaux, 33000, France
Investigational Site Number : 2500014
Clermont-Ferrand, 63100, France
Investigational Site Number : 2500001
Lille, 59037, France
Investigational Site Number : 2500013
Nice, 06202, France
Investigational Site Number : 2500007
Reims, 51100, France
Investigational Site Number : 2500012
Rouen, 76031, France
Investigational Site Number : 2500002
Toulouse, 31059, France
Investigational Site Number : 2760020
Augsburg, 86150, Germany
Investigational Site Number : 2760009
Bad Bentheim, 48455, Germany
Investigational Site Number : 2762203
Berlin, 10117, Germany
Investigational Site Number : 2762202
Blankenfelde-Mahlow, 15831, Germany
Investigational Site Number : 2761001
Dresden, 01307, Germany
Investigational Site Number : 2762207
Gera, 07548, Germany
Investigational Site Number : 2760017
Hamburg, 20095, Germany
Investigational Site Number : 2760021
Hamburg, 20354, Germany
Investigational Site Number : 2762208
Kiel, 24105, Germany
Investigational Site Number : 2761002
Lübeck, 23562, Germany
Investigational Site Number : 2760016
Mainz, 55128, Germany
Investigational Site Number : 2762201
Münster, 48149, Germany
Investigational Site Number : 3000001
Athens, 16121, Greece
Investigational Site Number : 3000002
Thessaloniki, 54643, Greece
Investigational Site Number : 3482303
Debrecen, 4032, Hungary
Investigational Site Number : 3482306
Szolnok, 5000, Hungary
Investigational Site Number : 3560001
Ahmedabad, 380016, India
Investigational Site Number : 3560005
Belagavi, 590002, India
Investigational Site Number : 3560004
Chandigarh, 160012, India
Investigational Site Number : 3560007
Kolkata, 700073, India
Investigational Site Number : 3560002
Nagpur, 441203, India
Investigational Site Number : 3560003
Pune, 411057, India
Investigational Site Number : 3760004
Afula, 1834111, Israel
Investigational Site Number : 3760005
Beersheba, 8457108, Israel
Investigational Site Number : 3760003
Jerusalem, 9112001, Israel
Investigational Site Number : 3760006
Petah Tikva, 4920235, Israel
Investigational Site Number : 3760002
Petah Tikva, 4941492, Israel
Investigational Site Number : 3760008
Ramat Gan, 5262100, Israel
Investigational Site Number : 3760007
Tel Aviv, 6423906, Israel
Investigational Site Number : 3800003
Milan, Milano, 20122, Italy
Investigational Site Number : 3800018
Rozzano, Milano, 20089, Italy
Investigational Site Number : 3800017
Naples, Napoli, 80131, Italy
Investigational Site Number : 3800020
Turin, Torino, 10126, Italy
Investigational Site Number : 3800016
Chieti, 66100, Italy
Investigational Site Number : 3800011
L’Aquila, 67100, Italy
Investigational Site Number : 3800021
Modena, 41125, Italy
Investigational Site Number : 3800015
Perugia, 06156, Italy
Investigational Site Number : 3800008
Pisa, 56126, Italy
Investigational Site Number : 3920009
Chitose, Hokkaido, 066-0021, Japan
Investigational Site Number : 3923114
Obihiro, Hokkaido, 080-0013, Japan
Investigational Site Number : 3923101
Sapporo, Hokkaido, 060-0063, Japan
Investigational Site Number : 3920008
Sapporo, Hokkaido, 064-0921, Japan
Investigational Site Number : 3920006
Kobe, Hyōgo, 653-0836, Japan
Investigational Site Number : 3920005
Sagamihara, Kanagawa, 252-0315, Japan
Investigational Site Number : 3923113
Yokohama, Kanagawa, 221-0825, Japan
Investigational Site Number : 3923109
Habikino, Osaka, 583-8588, Japan
Investigational Site Number : 3923110
Sakai, Osaka, 593-8324, Japan
Investigational Site Number : 3920002
Iruma, Saitama, 350-0495, Japan
Investigational Site Number : 3923106
Mibu, Tochigi, 321-0293, Japan
Investigational Site Number : 3923115
Chūō, Tokyo, 103-0028, Japan
Investigational Site Number : 3920004
Chūō, Tokyo, 104-0031, Japan
Investigational Site Number : 3923104
Edogawa City, Tokyo, 133-0052, Japan
Investigational Site Number : 3923107
Minato, Tokyo, 108-0014, Japan
Investigational Site Number : 3923105
Setagaya City, Tokyo, 158-0097, Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo, 190-0023, Japan
Investigational Site Number : 3920007
Hiroshima, 734-8551, Japan
Investigational Site Number : 3923108
Kagoshima, 890-0063, Japan
Investigational Site Number : 3923102
Kyoto, 602-8566, Japan
Investigational Site Number : 3920003
Kyoto, 606-8507, Japan
Investigational Site Number : 3923112
Tokyo, 120-0034, Japan
Investigational Site Number : 3923113
Yokohama, 221-0825, Japan
Investigational Site Number : 4840005
Monterrey, Nuevo León, 64718, Mexico
Investigational Site Number : 4840009
Durango, 34000, Mexico
Investigational Site Number : 4840003
Veracruz, 91900, Mexico
Investigational Site Number : 6162412
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Investigational Site Number : 6162408
Krakow, Lesser Poland Voivodeship, 30-033, Poland
Investigational Site Number : 6162407
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Investigational Site Number : 6162409
Krakow, Lesser Poland Voivodeship, 31-011, Poland
Investigational Site Number : 6162406
Krakow, Lesser Poland Voivodeship, 31-209, Poland
Investigational Site Number: 6160010
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
Investigational Site Number : 6162414
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
Investigational Site Number : 6162418
Wroclaw, Lower Silesian Voivodeship, 51-318, Poland
Investigational Site Number : 6162417
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
Investigational Site Number: 6160004
Lublin, Lublin Voivodeship, 20-607, Poland
Investigational Site Number : 6162415
Lodz, Lódzkie, 90-127, Poland
Investigational Site Number : 6160022
Lodz, Lódzkie, 90-265, Poland
Investigational Site Number : 6162416
Lodz, Lódzkie, 90-436, Poland
Investigational Site Number : 6162411
Warsaw, Masovian Voivodeship, 01-142, Poland
Investigational Site Number : 6162413
Warsaw, Masovian Voivodeship, 01-192, Poland
Investigational Site Number: 6160009
Warsaw, Masovian Voivodeship, 02-625, Poland
Investigational Site Number: 6160007
Warsaw, Masovian Voivodeship, 02-962, Poland
Investigational Site Number : 6162401
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Investigational Site Number : 6162419
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Investigational Site Number : 6162402
Gdansk, Pomeranian Voivodeship, 80-382, Poland
Investigational Site Number : 6160006
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Investigational Site Number : 6162403
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Investigational Site Number : 6162404
Gdynia, Pomeranian Voivodeship, 81-537, Poland
Investigational Site Number : 6162405
Katowice, Silesian Voivodeship, 40-040, Poland
Investigational Site Number: 6160003
Katowice, Silesian Voivodeship, 40-611, Poland
Investigational Site Number : 6162410
Szczecin, West Pomeranian Voivodeship, 71-500, Poland
Investigational Site Number : 6200004
Lisbon, 1649-035, Portugal
Investigational Site Number : 6200001
Lisbon, 1998-018, Portugal
Investigational Site Number : 6200003
Porto, 4099-001, Portugal
Investigational Site Number : 6820001
Riyadh, 12713, Saudi Arabia
Investigational Site Number : 7100015
Benoni, 1500, South Africa
Investigational Site Number : 7100010
Cape Town, 7533, South Africa
Investigational Site Number: 7100009
Cape Town, 7708, South Africa
Investigational Site Number : 7100012
Durban, 3630, South Africa
Investigational Site Number : 7100001
Durban, 4058, South Africa
Investigational Site Number : 7100007
Johannesburg, 2196, South Africa
Investigational Site Number : 4100008
Daegu, Daegu, 41944, South Korea
Investigational Site Number : 4100012
Gwangju, Gwangju, 61453, South Korea
Investigational Site Number : 4100002
Ansan-si, Gyeonggi-do, 15355, South Korea
Investigational Site Number : 4100014
Seongnam-si, Gyeonggi-do, 13620, South Korea
Investigational Site Number : 4100009
Suwon, Gyeonggi-do, 16499, South Korea
Investigational Site Number : 4100003
Yangsan, Gyeongsangnam-do, 50612, South Korea
Investigational Site Number : 4100015
Bupyeong-Gu, Incheon-gwangyeoksi, 21431, South Korea
Investigational Site Number : 4100010
Seoul, Seoul-teukbyeolsi, 01812, South Korea
Investigational Site Number : 4100013
Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, 05030, South Korea
Investigational Site Number : 4100011
Seoul, Seoul-teukbyeolsi, 06591, South Korea
Investigational Site Number : 4100017
Seoul, Seoul-teukbyeolsi, 07804, South Korea
Investigational Site Number : 7240002
Badalona, Barcelona [Barcelona], 08916, Spain
Investigational Site Number : 7240008
Bilbao, Basque Country, 48013, Spain
Investigational Site Number : 7240012
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Investigational Site Number : 7240015
Pamplona, Navarre, 31008, Spain
Investigational Site Number : 7242504
Pontevedra, Pontevedra [Pontevedra], 36002, Spain
Investigational Site Number : 7240014
Vigo, Pontevedra [Pontevedra], 36206, Spain
Investigational Site Number : 7240020
Seville, Sevilla, 41013, Spain
Investigational Site Number : 7240023
Burjassot, Valencia, 46100, Spain
Investigational Site Number : 7242505
Alicante, 03010, Spain
Investigational Site Number : 7242501
Córdoba, 14004, Spain
Investigational Site Number : 7240018
Granada, 18014, Spain
Investigational Site Number : 7240019
Granada, 18016, Spain
Investigational Site Number : 7242503
Madrid, 28046, Spain
Investigational Site Number : 1583201
Kaohsiung City, 833, Taiwan
Investigational Site Number : 1583202
Taichung, 402, Taiwan
Investigational Site Number : 1580001
Taipei, 10016, Taiwan
Investigational Site Number : 1583203
Taoyuan City, 333, Taiwan
Investigational Site Number : 7920001
Antalya, 07070, Turkey (Türkiye)
Investigational Site Number : 7920008
Gaziantep, 27310, Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, 34093, Turkey (Türkiye)
Investigational Site Number : 7920009
Istanbul, 34662, Turkey (Türkiye)
Investigational Site Number : 7920004
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number : 7840001
Abu Dhabi, 4167, United Arab Emirates
Investigational Site Number : 7841002
Abu Dhabi, 51900, United Arab Emirates
Investigational Site Number : 8260013
Bristol, Bristol, City of, BS2 8HW, United Kingdom
Investigational Site Number : 8262603
London, England, E11 1NR, United Kingdom
Investigational Site Number : 8260006
Glasgow, Glasgow City, G12 0YN, United Kingdom
Investigational Site Number : 8260003
Portsmouth, Hampshire, PO3 6DW, United Kingdom
Investigational Site Number : 8260004
Leicester, Leicestershire, LE1 5WW, United Kingdom
Investigational Site Number : 8260016
London, London, City of, Se1 7eh, United Kingdom
Investigational Site Number : 8262601
London, London, City of, SE1 9RT, United Kingdom
Investigational Site Number : 8260010
Nottingham, Nottinghamshire, NG17 4JL, United Kingdom
Investigational Site Number : 8260008
Liverpool, L7 8XP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 8, 2022
Study Start
August 22, 2022
Primary Completion (Estimated)
January 22, 2029
Study Completion (Estimated)
January 22, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org