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Active, not recruitingNCT06241118AQUAUpdated Aug 27, 2026

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

A Phase 3 interventional study of Amlitelimab and Placebo in Dermatitis Atopic, sponsored by Sanofi. Active, not recruiting at 150 sites in 23 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
464
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.

Study details include:

At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).

The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.

The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period.

The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

02

Conditions studied

  • Dermatitis Atopic

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03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must be 12 years of age (when signing informed consent form)
  • Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
  • Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
  • v-IGA-AD of 3 or 4 at baseline visit
  • EASI score of 16 or higher at baseline
  • AD involvement of 10% or more of BSA at baseline
  • Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
  • Able and willing to comply with requested study visits and procedures
  • Body weight ≥25 kg

Exclusion criteria

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments
  • Known history of or suspected significant current immunosuppression
  • Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
  • History of solid organ or stem cell transplant
  • Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
  • Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
  • Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
  • Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
  • In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
  • History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
464 participants (actual)

Study arms

  • Experimental
    Amlitelimab dose 1

    Subcutaneous injection as per protocol

    Drug: Amlitelimab · Drug: Topical corticosteroids · Drug: Topical tacrolimus or pimecrolimus

  • Experimental
    Amlitelimab dose 2

    Subcutaneous injection as per protocol

    Drug: Amlitelimab · Drug: Topical corticosteroids · Drug: Topical tacrolimus or pimecrolimus

  • Placebo comparator
    Placebo

    Subcutaneous injection as per protocol

    Drug: Placebo · Drug: Topical corticosteroids · Drug: Topical tacrolimus or pimecrolimus

Interventions

  • DrugAmlitelimab

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

    Also known as: SAR445229

  • DrugPlacebo

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

  • DrugTopical corticosteroids

    Pharmaceutical form: Various Topical formulation Route of administration: Topical

  • DrugTopical tacrolimus or pimecrolimus

    Pharmaceutical form: Various Topical formulation Route of administration: Topical

05

What researchers measure

Primary outcomes

  1. EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Week 36

  2. EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Time frame: Week 36

  3. US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Week 36

Secondary outcomes

  1. Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only)

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.

    Time frame: Week 36

  2. Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting and a reduction from baseline of ≥2 points)

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Baseline to Week 36

  3. Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Time frame: Baseline to Week 36

  4. Proportion of participants reaching EASI-75

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.

    Time frame: Baseline to Week 24

  5. Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Baseline to Week 24

  6. Proportion of participants reaching EASI-90

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.

    Time frame: Baseline to Week 36

  7. Proportion of participants reaching EASI-100

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.

    Time frame: Baseline to Week 36

  8. Proportion of participants with PP-NRS ≤1

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Time frame: Baseline to Week 36

  9. Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 36

  10. Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 36

  11. Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years

    The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 36

  12. Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6

    The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 36

  13. Change in Hospital Anxiety Depression Scale (HADS) from baseline

    The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

    Time frame: Baseline to Week 36

  14. Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8

    HADS-A score ranges 0-21 with higher score indicating a poorer state.

    Time frame: Baseline to Week 36

  15. Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8

    HADS-D score ranges 0-21 with higher score indicating a poorer state.

    Time frame: Baseline to Week 36

  16. Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline

    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.

    Time frame: Baseline to Week 36

  17. Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4

    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.

    Time frame: Baseline to Week 36

  18. Percent change in weekly average of daily SP-NRS from baseline

    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.

    Time frame: Baseline to Week 36

  19. Proportion of participants with vIGA-AD 0 (clear)

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Baseline to Week 36

  20. Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline

    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.

    Time frame: Baseline to Week 36

  21. Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3

    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.

    Time frame: Baseline to Week 36

  22. Percent change in weekly average of daily SD-NRS

    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.

    Time frame: Baseline to Week 36

  23. Percent change in EASI score from baseline

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Time frame: Baseline to Week 36

  24. Percent change in weekly average of daily PP-NRS from baseline

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Time frame: Baseline to Week 36

  25. Absolute change in weekly average of daily PP-NRS from baseline

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Time frame: Baseline to Week 36

  26. Proportion of participants reaching EASI-50

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.

    Time frame: Baseline to Week 36

  27. Proportion of participants with EASI ≤7

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Time frame: Baseline to Week 36

  28. Change in percent Body Surface Area (BSA) affected by AD from baseline

    Time frame: Baseline to Week 36

  29. Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline

    The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).

    Time frame: Baseline to Week 36

  30. Absolute change in SCORAD index from baseline

    The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).

    Time frame: Baseline to Week 36

  31. Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7

    The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).

    Time frame: Baseline to Week 36

  32. Proportion of participants with a reduction in Patient Oriented Eczema Measure (POEM) ≥4 from baseline in participants with POEM Baseline ≥4

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.

    Time frame: Baseline to Week 36

  33. Change in POEM from baseline

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.

    Time frame: Baseline to Week 36

  34. Proportion of participants with rescue medication use

    Time frame: Baseline to Week 36

  35. Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥4

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Time frame: Baseline to Week 36

  36. Percentage of TCS/TCI free days

    Time frame: Baseline to Week 36

  37. Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), experienced Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)

    Time frame: Baseline to Week 52

  38. Serum amlitelimab concentrations

    Time frame: Baseline to Week 52

  39. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Time frame: Baseline to Week 52

  40. Time to onset of effect on vIGA-AD as measured by proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and a reduction from baseline ≥2 during the 36-week treatment period

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Time frame: Baseline to Week 36

  41. Time to onset of effect on EASI as measured by proportion of participants reaching a 75% reduction from baseline in EASI score during the 36-week treatment period

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.

    Time frame: Baseline to Week 36

06

Study locations

150 sites
  • University of Alabama at Birmingham- Site Number : 8401267
    Birmingham, Alabama 35233, United States
  • Center for Dermatology and Plastic Surgery- Site Number : 8401119
    Scottsdale, Arizona 85260, United States
  • Arkansas Dermatology - North Little Rock- Site Number : 8401244
    North Little Rock, Arkansas 72117, United States
  • Encino Research Center- Site Number : 8401042
    Encino, California 91436, United States
  • Center for Dermatology Clinical Research- Site Number : 8401018
    Fremont, California 94538, 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
  • University Dermatology Trials- Site Number : 8401339
    Newport Beach, California 92660, United States
  • Rady Children's Hospital- Site Number : 8401291
    San Diego, California 92123, United States
  • Therapeutics Clinical Research- Site Number : 8401283
    San Diego, California 92123, 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
  • St. Jude Clinical Research- Site Number : 8401287
    Doral, Florida 33172, 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
  • Global Clinical Professionals (GCP)- Site Number : 8401045
    St. Petersburg, Florida 33714, United States
  • Avita Clinical Research- Site Number : 8401073
    Tampa, Florida 33613, United States
  • Northwestern University- Site Number : 8401285
    Chicago, Illinois 60611, United States
  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
    Skokie, Illinois 60077, United States
  • Dawes Fretzin Clinical Research- Site Number : 8401015
    Indianapolis, Indiana 46256, United States
  • Equity Medical - Bowling Green- Site Number : 8401296
    Bowling Green, Kentucky 42104, United States
  • Tandem Clinical Research - Metairie- Site Number : 8401187
    Metairie, Louisiana 70006, United States
  • University of Michigan Health System - Ann Arbor- Site Number : 8401290
    Ann Arbor, Michigan 48109, United States
  • MI Skin Center- Site Number : 8401307
    Northville, Michigan 48167, United States
  • Skin Specialists- Site Number : 8401068
    Omaha, Nebraska 68144, United States
  • Schweiger Dermatology Group - East Windsor- Site Number : 8401338
    East Windsor, New Jersey 08520, 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
  • Cincinnati Children's Hospital Medical Center- Site Number : 8401279
    Cincinnati, Ohio 45229, United States
  • Oregon Health & Science University (OHSU)- Site Number : 8401247
    Portland, Oregon 97239, 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
  • Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
    Charleston, South Carolina 29425, United States
  • Arlington Research Center- Site Number : 8401248
    Arlington, Texas 76011, United States
  • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
    Bellaire, Texas 77401, United States
  • Reveal Research Institute - Dallas- Site Number : 8401219
    Dallas, Texas 75235, United States
  • Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057
    Ogden, Utah 84405, United States
  • Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
    Norfolk, Virginia 23502, United States
  • North Sound Dermatology- Site Number : 8401280
    Mill Creek, Washington 98012, United States
  • Children's Wisconsin- Site Number : 8401246
    Milwaukee, Wisconsin 53226, United States
  • Cheyenne Skin Clinic- Site Number : 8401234
    Cheyenne, Wyoming 82009, United States
  • Investigational Site Number : 0320007
    Rosario, Santa Fe Province 2000, Argentina
  • Investigational Site Number : 0320011
    Buenos Aires, 1035, Argentina
  • Investigational Site Number : 0320019
    Buenos Aires, 1426, Argentina
  • Investigational Site Number : 0320014
    Córdoba, 5000, Argentina
  • Investigational Site Number : 0360008
    Melbourne, Victoria 3002, Australia
  • Investigational Site Number : 0360006
    Melbourne, Victoria 3004, Australia
  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
    Salvador, Estado de Bahia 41820-020, Brazil
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
    Porto Alegre, Rio Grande do Sul 90020-090, 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
  • 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
  • Investigational Site Number : 1240019
    Calgary, Alberta T2W 4X9, Canada
  • Investigational Site Number : 1240016
    Edmonton, Alberta T5J 3S9, Canada
  • Investigational Site Number : 1240058
    Burlington, Ontario L7L 6W6, Canada
  • Investigational Site Number : 1240020
    Hamilton, Ontario L8L 3C3, Canada
  • Investigational Site Number : 1240053
    London, Ontario N6A 5R9, Canada
  • Investigational Site Number : 1240035
    Toronto, Ontario M5A 3R6, Canada
  • Investigational Site Number : 1240054
    Toronto, Ontario M5m 3z8, Canada
  • Investigational Site Number : 1240028
    Regina, Saskatchewan S4V 1R9, Canada
  • 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 : 1520010
    Santiago, Reg Metropolitana de Santiago 8330034, 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 : 1560031
    Changchun, 130021, China
  • Investigational Site Number : 1560057
    Chongqing, 400016, China
  • Investigational Site Number : 1560021
    Guangzhou, 510018, China
  • Investigational Site Number : 1560036
    Guangzhou, 510100, China
  • Investigational Site Number : 1560044
    Hangzhou, 310003, China
  • Investigational Site Number : 1560002
    Hangzhou, 310006, China
  • Investigational Site Number : 1560009
    Hangzhou, 310009, China
  • Investigational Site Number : 1560034
    Nanyang, 473014, 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 : 1560038
    Wuhan, 430030, China
  • Investigational Site Number : 1560032
    Xi'an, 710004, China
  • Investigational Site Number : 2500011
    Bordeaux, 33000, France
  • Investigational Site Number : 2500014
    Clermont-Ferrand, 63100, France
  • Investigational Site Number : 2500004
    Créteil, 94010, France
  • Investigational Site Number : 2500001
    Lille, 59037, France
  • Investigational Site Number : 2500017
    Paris, 75010, France
  • Investigational Site Number : 2500012
    Rouen, 76031, France
  • 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 : 2760022
    Frankfurt, 60590, Germany
  • Investigational Site Number : 2761002
    Lübeck, 23562, Germany
  • Investigational Site Number : 2760019
    Witten, 58453, Germany
  • Investigational Site Number : 3000004
    Athens, 124 62, Greece
  • Investigational Site Number : 3000001
    Athens, 16121, Greece
  • Investigational Site Number : 3000005
    Athens, 16121, Greece
  • Investigational Site Number : 3000002
    Thessaloniki, 54643, Greece
  • Investigational Site Number : 3760005
    Beersheba, 8457108, Israel

Showing the first 100 of 150 sites across 23 countries.

07

References and documents

Individual participant data

Plan to share: Yes — 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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06241118
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Feb 5, 2024
Start date
Feb 29, 2024
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 29, 2028 (estimated)
Last update
Aug 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Sanofi

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