Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT05769777
- Lead Sponsor
- Sanofi
- Brief Summary
This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).
The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.
The study duration per participant will be up to 180 weeks, including:
* A screening period of up to 2 to 4 weeks
* An open label treatment period of up to 160 weeks (approximately 3 years)
* A post-treatment safety follow-up period of at least 20 weeks after the last dose administration
The planned number of visits will be 26 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 901
- Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
- Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
- Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
- Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
- Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
- AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
- Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
- Able and willing to comply with requested study visits and procedures.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
- Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- 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).
- History of solid organ or stem cell transplant.
- Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
- Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
- Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
- Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
- Participants with active tuberculosis (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.
- In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
- In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
- History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amlitelimab Amlitelimab Subcutaneous injection as per protocol
- Primary Outcome Measures
Name Time Method Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) Baseline up to end of study (EOS) (Week 176) Percentage of participants who experienced TEAEs from baseline during the study
Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs) Baseline up to EOS (Week 176) Percentage of participants who experienced TESAEs from baseline during the study
- Secondary Outcome Measures
Name Time Method Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline Baseline to EOS (Week 176) 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).
Proportion of participants with PP-NRS 0 or 1 Baseline to EOS (Week 176) The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI) Baseline up to EOS (Week 176) Percentage of participants who experienced AESI from baseline during the study
Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG) Baseline up to EOS (Week 176) Percentage of participants discontinued from study treatment due to Adverse Events (AEs) Baseline up to EOS (Week 176) Percent change from baseline in Eczema Area and Severity Index (EASI) score Baseline to EOS (Week 176) The EASI is an Investigator-assessed tool used to measure the extent (area) and severity of AD. The severity is assessed based on 4 disease characteristics (erythema, induration/papulation, excoriation and lichenification). The extent of involvement of AD is assessed in 4 body regions (head/neck, trunk, upper extremities and lower extremities). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Proportion of participants with at least a ≥75% reduction in EASI score (EASI-75) from baseline Baseline to EOS (Week 176) EASI75: ≥ 75% reduction in EASI score from baseline
Proportion of participants with EASI-50 /EASI-90 /EASI-100 Baseline to EOS (Week 176) EASI-50: ≥50% reduction in EASI score from baseline; EASI-90: ≥90% reduction in EASI score from baseline; EASI-100: ≥100% reduction in EASI score from baseline.
Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age ≥16 years old Baseline to EOS (Week 176) The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
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 Baseline to EOS (Week 176) 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).
Proportion of participants with vIGA-AD of 0 Baseline to EOS (Week 176) 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).
Change in percent Body Surface Area (BSA) affected by AD from baseline Baseline to EOS (Week 176) BSA affected by AD will measure the extent (area) of the disease.
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline Baseline to EOS (Week 176) The SCORAD Index is a clinical tool used to standardise the evaluation of the extent and severity of AD. To determine the extent of AD, the affected area (A) as a percentage of the whole body is determined, with a maximum score of 100%. The severity (B) of 6 specific symptoms of AD (redness, swelling, oozing/crusting, scratch marks, skin thickening \[lichenification\], dryness \[area where there is no inflammation\]) is assessed on a 4-point scale, with a maximum score of 18: none (0), mild (1), moderate (2) or severe (3). Subjective symptoms (C): itch and sleeplessness are recorded as scored by the participants or relative on a visual analogue scale (VAS), where 0 = no itch (or sleeplessness) and 10 = worst imaginable itch (or sleeplessness), with a maximum possible score of 20.
Proportion of participants requiring rescue treatment at each visit Baseline to EOS (Week 176) 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 Baseline to EOS (Week 176) The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Percent change in weekly average of daily PP-NRS from baseline Baseline to EOS (Week 176) The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline Baseline to EOS (Week 176) The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
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 Baseline to EOS (Week 176) The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
Change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline Baseline to EOS (Week 176) The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".
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 Baseline to EOS (Week 176) The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".
Change in Patient Oriented Eczema Measure (POEM) from baseline Baseline to EOS (Week 176) The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
Proportion of participants with a reduction in POEM ≥4 from Baseline in participants with POEM baseline ≥4 Baseline to EOS (Week 176) The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
Proportion of adolescent participants with a reduction in POEM ≥6 from Baseline in adolescents with POEM baseline ≥6 Baseline to EOS (Week 176) The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
Change in Atopic Dermatitis Control Test (ADCT) from baseline Baseline to EOS (Week 176) The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Proportion of participants with a reduction in ADCT ≥5 from baseline in participants with baseline ADCT≥7 Baseline to EOS (Week 176) The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old Baseline to EOS (Week 176) The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to \<16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥4 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6 Baseline to EOS (Week 176) The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to \<16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥6 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6 Baseline to EOS (Week 176) The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to \<16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Proportion of participants with a reduction in DLQI ≥4 from Baseline in participants with age ≥16 years old and with DLQI at baseline ≥4 Baseline to EOS (Week 176) The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Change in Patient Global Impression of Severity (PGIS) from baseline Baseline to EOS (Week 176) The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Proportions of participants who report symptoms to be "No" on the PGIS score Baseline to EOS (Week 176) The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score Baseline to EOS (Week 176) The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale Week 16 to EOS (Week 176) The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
Proportion of participants who respond "Much better" or "A little better" on the PGIC scale Week 16 to EOS (Week 176) The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
Proportion of participants by PGIC responses Week 16 to EOS (Week 176) The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
Change in Hospital Anxiety Depression Scale (HADS) from baseline Baseline to EOS (Week 176) The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 Baseline to EOS (Week 176) The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
HADS-A is the anxiety HADS subscale.Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D Baseline ≥8 Baseline to EOS (Week 176) The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
HADS-D is the depression HADS subscale.
Trial Locations
- Locations (172)
Investigational Site Number : 0320003
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320002
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320004
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320009
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320005
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 1560019
🇨🇳Xinxiang, China
Investigational Site Number : 1560012
🇨🇳Yinchuan, China
Investigational Site Number : 1560028
🇨🇳Zhenjiang, China
Investigational Site Number : 2032105
🇨🇿Nový Jičín, Czechia
Investigational Site Number : 2032104
🇨🇿Ostrava, Czechia
Investigational Site Number : 2032102
🇨🇿Prague, Czechia
Investigational Site Number : 2030003
🇨🇿Prague, Czechia
Investigational Site Number : 2030006
🇨🇿Prague, Czechia
Investigational Site Number : 2030007
🇨🇿Prague, Czechia
Investigational Site Number : 2080001
🇩🇰Aarhus, Denmark
Investigational Site Number : 2500004
🇫🇷Créteil, France
Investigational Site Number : 2500001
🇫🇷Lille, France
Investigational Site Number : 2500005
🇫🇷Marseille, France
Investigational Site Number : 2500003
🇫🇷Paris, France
Investigational Site Number : 2500006
🇫🇷Pierre-bénite, France
Investigational Site Number : 2500002
🇫🇷Toulouse, France
Investigational Site Number : 2760009
🇩🇪Bad Bentheim, Germany
Investigational Site Number : 2762203
🇩🇪Berlin, Germany
Investigational Site Number : 2762201
🇩🇪Münster, Germany
Investigational Site Number : 2760010
🇩🇪Osnabrück, Germany
Investigational Site Number : 3560007
🇮🇳Bikaner, India
Investigational Site Number : 3560003
🇮🇳Gurugram, India
Investigational Site Number : 3560005
🇮🇳Kolkata, India
Investigational Site Number : 3560004
🇮🇳Mangaluru, India
Investigational Site Number : 3560002
🇮🇳Nashik, India
Investigational Site Number : 3560008
🇮🇳Surat, India
Investigational Site Number : 5280001
🇳🇱Utrecht, Netherlands
Investigational Site Number : 6160009
🇵🇱Warsaw, Mazowieckie, Poland
Investigational Site Number : 1583202
🇨🇳Taichung, Taiwan
Investigational Site Number : 1580007
🇨🇳Taichung, Taiwan
Investigational Site Number : 1580001
🇨🇳Taipei City, Taiwan
Investigational Site Number : 1583203
🇨🇳Taoyuan City, Taiwan
Investigational Site Number : 8260001
🇬🇧London, England, United Kingdom
Investigational Site Number : 8262601
🇬🇧London, London, City Of, United Kingdom
Investigational Site Number : 8260002
🇬🇧Edinburgh, United Kingdom
Alabama Allergy & Asthma Center - Birmingham - Brookwood Boulevard- Site Number : 8400050
🇺🇸Birmingham, Alabama, United States
Research Solutions of Arizona- Site Number : 8400020
🇺🇸Litchfield Park, Arizona, United States
Medical Dermatology Specialists- Site Number : 8400016
🇺🇸Phoenix, Arizona, United States
Dermatology Trial Associates- Site Number : 8400027
🇺🇸Bryant, Arkansas, United States
University Dermatology Trials, INC.- Site Number : 8400052
🇺🇸Newport Beach, California, United States
Children's Hospital Colorado - Aurora- Site Number : 8400041
🇺🇸Aurora, Colorado, United States
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
🇺🇸Centennial, Colorado, United States
Renaissance Research and Medical Group- Site Number : 8400006
🇺🇸Cape Coral, Florida, United States
Life Clinical Trials - Coral Springs- Site Number : 8400040
🇺🇸Coral Springs, Florida, United States
Florida Pharmaceutical Research and Associates- Site Number : 8400018
🇺🇸Miami, Florida, United States
Bio-Medical Research- Site Number : 8400037
🇺🇸Miami, Florida, United States
Miami Clinical Research Tower- Site Number : 8400036
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.- Site Number : 8400011
🇺🇸Miami, Florida, United States
Clinical Research Trials of Florida- Site Number : 8400054
🇺🇸Tampa, Florida, United States
Advanced Medical Research - Atlanta- Site Number : 8400044
🇺🇸Atlanta, Georgia, United States
Georgia Skin & Cancer Clinic- Site Number : 8400048
🇺🇸Savannah, Georgia, United States
Sneeze Wheeze And Itch Assoc- Site Number : 8400002
🇺🇸Normal, Illinois, United States
Velocity Clinical Research - Sioux City- Site Number : 8400046
🇺🇸Sioux City, Iowa, United States
Kentucky Advanced Medical Research- Site Number : 8400014
🇺🇸Murray, Kentucky, United States
Velocity Clinical Research - Baton Rouge- Site Number : 8400005
🇺🇸Baton Rouge, Louisiana, United States
Oakland Hills Dermatology- Site Number : 8400021
🇺🇸Auburn Hills, Michigan, United States
The Derm Institute of West Michigan- Site Number : 8400043
🇺🇸Caledonia, Michigan, United States
Michigan Dermatology Institute- Site Number : 8401010
🇺🇸Livonia, Michigan, United States
Somerset Skin Centre- Site Number : 8400038
🇺🇸Troy, Michigan, United States
Grekin Skin Institute - Warren- Site Number : 8400042
🇺🇸Warren, Michigan, United States
Michigan Dermatology Institute- Site Number : 8400010
🇺🇸Waterford, Michigan, United States
Forest Hills Dermatology Group @ Union Turnpike- Site Number : 8400007
🇺🇸Kew Gardens, New York, United States
Aesthetic Dermatology- Site Number : 8400031
🇺🇸Woodbury, New York, United States
Unity Clinical Research- Site Number : 8400001
🇺🇸Oklahoma City, Oklahoma, United States
The Children's Hospital of Philadelphia- Site Number : 8400009
🇺🇸Philadelphia, Pennsylvania, United States
Pioneer Research Solutions- Site Number : 8400026
🇺🇸Sugar Land, Texas, United States
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
🇺🇸Burlington, Wisconsin, United States
Investigational Site Number : 0320022
🇦🇷General Pico, La Pampa, Argentina
Investigational Site Number : 0320006
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320007
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320008
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320001
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0360002
🇦🇺Kogarah, New South Wales, Australia
Investigational Site Number : 0360001
🇦🇺Sydney, New South Wales, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
🇧🇷Salvador, Bahia, Brazil
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná- Site Number : 0760022
🇧🇷Curitiba, Paraná, Brazil
Pontifica Universidade Catolica do Parana- Site Number : 0760023
🇧🇷Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
🇧🇷Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
🇧🇷Santo André, São Paulo, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760006
🇧🇷Sorocaba, São Paulo, Brazil
Hospital de Base de São José do Rio Preto- Site Number : 0760003
🇧🇷São José Do Rio Preto, São Paulo, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
🇧🇷Rio de Janeiro, Brazil
Investigational Site Number : 1240001
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240052
🇨🇦Edmonton, Alberta, Canada
Investigational Site Number : 1240009
🇨🇦Etobicoke, Ontario, Canada
Investigational Site Number : 1240008
🇨🇦Mississauga, Ontario, Canada
Investigational Site Number : 1240011
🇨🇦Oakville, Ontario, Canada
Investigational Site Number : 1240004
🇨🇦Peterborough, Ontario, Canada
Investigational Site Number : 1240003
🇨🇦Richmond Hill, Ontario, Canada
Investigational Site Number : 1240012
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240002
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 1240010
🇨🇦Québec City, Quebec, Canada
Investigational Site Number : 1240006
🇨🇦Québec City, Quebec, Canada
Investigational Site Number : 1240044
🇨🇦Saskatoon, Saskatchewan, Canada
Investigational Site Number : 1520009
🇨🇱Osorno, Los Lagos, Chile
Investigational Site Number : 1520004
🇨🇱Valdivia, Los Ríos, Chile
Investigational Site Number : 1520011
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520008
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520013
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520010
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520005
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520014
🇨🇱Chillán, Chile
Investigational Site Number : 1560015
🇨🇳Beijing, China
Investigational Site Number : 1560008
🇨🇳Changchun, China
Investigational Site Number : 1560016
🇨🇳Changsha, China
Investigational Site Number : 1560014
🇨🇳Chengdu, China
Investigational Site Number : 1560072
🇨🇳Fuzhou, China
Investigational Site Number : 1560074
🇨🇳Guangzhou, China
Investigational Site Number : 1560044
🇨🇳Hangzhou, China
Investigational Site Number : 1560011
🇨🇳Hangzhou, China
Investigational Site Number : 1560013
🇨🇳Jingzhou, China
Investigational Site Number : 1560001
🇨🇳Shanghai, China
Investigational Site Number : 1560018
🇨🇳Suzhou, China
Investigational Site Number : 1560010
🇨🇳Taiyuan, China
Investigational Site Number : 1560073
🇨🇳Taizhou, China
Investigational Site Number : 3800003
🇮🇹Milan, Milano, Italy
Investigational Site Number : 3800002
🇮🇹Naples, Napoli, Italy
Investigational Site Number : 3800004
🇮🇹Naples, Napoli, Italy
Investigational Site Number : 3800007
🇮🇹Rome, Roma, Italy
Investigational Site Number : 3800006
🇮🇹Rome, Roma, Italy
Investigational Site Number : 3800005
🇮🇹Brescia, Italy
Investigational Site Number : 3923114
🇯🇵Obihiro, Hokkaido, Japan
Investigational Site Number : 3923113
🇯🇵Yokohama, Kanagawa, Japan
Investigational Site Number : 3923110
🇯🇵Sakai, Osaka, Japan
Investigational Site Number : 3923106
🇯🇵Mibu, Tochigi, Japan
Investigational Site Number : 3920001
🇯🇵Tachikawa, Tokyo, Japan
Investigational Site Number : 4100002
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100016
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Investigational Site Number : 4100018
🇰🇷Incheon, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100006
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4840001
🇲🇽Chihuahua, Mexico
Investigational Site Number : 4840008
🇲🇽Durango, Mexico
Investigational Site Number : 5280002
🇳🇱Breda, Netherlands
Investigational Site Number : 5280004
🇳🇱Rotterdam, Netherlands
Investigational Site Number : 6160007
🇵🇱Warsaw, Mazowieckie, Poland
Investigational Site Number : 6160006
🇵🇱Gdansk, Pomorskie, Poland
Investigational Site Number : 6160001
🇵🇱Chorzow, Slaskie, Poland
Investigational Site Number : 6160003
🇵🇱Katowice, Slaskie, Poland
Dr. Samuels Sanchez P.S.C.- Site Number : 8400045
🇵🇷Caguas, Puerto Rico
Caribbean Medical Research Center- Site Number : 8400028
🇵🇷San Juan, Puerto Rico
Investigational Site Number : 7100004
🇿🇦Boksburg, South Africa
Investigational Site Number : 7100011
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100010
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100002
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100009
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100012
🇿🇦Durban, South Africa
Investigational Site Number : 7100015
🇿🇦Durban, South Africa
Investigational Site Number : 7100006
🇿🇦Johannesburg, South Africa
Investigational Site Number : 7100007
🇿🇦Johannesburg, South Africa
Investigational Site Number : 7100005
🇿🇦Middelburg, South Africa
Investigational Site Number : 7100003
🇿🇦Pretoria, South Africa
Investigational Site Number : 7100014
🇿🇦Pretoria, South Africa
Investigational Site Number : 7240002
🇪🇸Badalona, Barcelona [Barcelona], Spain
Investigational Site Number : 7242505
🇪🇸Alicante, Spain
Investigational Site Number : 7242501
🇪🇸Córdoba, Spain
Investigational Site Number : 7242503
🇪🇸Madrid, Spain
Investigational Site Number : 7240006
🇪🇸Valencia, Spain
Investigational Site Number : 7560002
🇨🇭Buochs, Switzerland
Investigational Site Number : 1580006
🇨🇳Hsinchu, Taiwan
Investigational Site Number : 1583201
🇨🇳Kaohsiung City, Taiwan
Investigational Site Number : 1580002
🇨🇳New Taipei City, Taiwan