Clinical trial NCT06407934: A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Official title: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-05-09
Enrollment: 961
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).

The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \[COAST-1\], EFC17560 \[COAST 2\], EFC17561 \[SHORE\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal.

Study details include:

The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).

The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).

The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
* Able and willing to comply with requested study visit and procedures.
* Body weight must be ≥ 25 kg.

Exclusion Criteria:

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

* Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

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

Primary outcomes:
measure: Proportion of participants who maintain treatment response at Week 48 of ESTUARY.
timeFrame: Week 48
Secondary outcomes:
measure: Responders from parent studies: Proportion of participants who continue to be EASI-75 among the participants who met EASI-75 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who maintained weekly average of daily PP-NRS reduction of ≥4 among the participants with weekly average of daily PP-NRS reduction of ≥ 4 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Proportion of participants who maintain treatment response in ESTUARY
timeFrame: Up to Week 44
measure: Responders from parent studies: Percent change in EASI from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants with EASI-75
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with EASI-50
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who continue to be EASI-90 among the participants who met EASI-90 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with EASI-90
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who continue to be EASI-100 among the participants who met EASI-100 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with EASI-100
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to the first event of loss of EASI-75 response among the participants who were EASI-75 responders at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to the first event of loss of EASI-50 response among the participants who were EASI-50 responders at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to the first event of loss of EASI-90 response among the participants who were EASI-90 responders at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to the first event of loss of EASI-100 among participants who were EASI-100 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75 and weekly average of daily (WAD) PP-NRS reduction >4 among those who were vIGA-AD 0 or 1 and/or EASI-75 and WAD PP-NRS reduction >4 at BL of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of ≥ 3 among the participants with weekly average of daily SD-NRS reduction of ≥3 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of ≥ 4 among the participants with weekly average of daily SP-NRS reduction of ≥4 at ESTUARY baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants who maintained SCORAD ≥ 8.7 among participants with reduction in SCORAD ≥ 8.7 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Percent change in SCORAD index from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Absolute change in SCORAD index from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants who maintained POEM ≥4 among the participants with reduction in POEM ≥4 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Change in POEM from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants with a reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 among participants aged ≥12 to <16 years old and with CDLQI baseline ≥6
timeFrame: Up to Week 48
measure: Responders from parent studies: Change in CDLQI in participants with age ≥12 to <16 years old
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Change in Dermatology Life Quality Index (DLQI) in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Responders from parent studies: Proportion of participants with ≥ 4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline
timeFrame: Up to Week 48
measure: Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY
timeFrame: Up to Week 48
measure: Responders from parent studies: Time to first rescue medication initiation
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Percent change in EASI from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Proportion of participants with EASI-75
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with EASI-50
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with EASI-90
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with EASI-100
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Proportion of participants with a reduction in CDLQI ≥6 among participants aged ≥12 to <16 years old and with CDLQI ≥6 at parent study baseline
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Change in CDLQI in participants with age ≥12 to <16 years old
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Change in DLQI in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline
timeFrame: Parent study baseline to Week 48
measure: Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline
timeFrame: Up to Week 48
measure: Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline
timeFrame: Up to Week 48
measure: All participants: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
timeFrame: Up to week 68
measure: All participants: Serum amlitelimab concentrations measured at prespecified timepoints
timeFrame: Up to Week 68
measure: All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab
timeFrame: Up to Week 68
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center- Site Number : 8401066
state: Alabama
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery- Site Number : 8401119
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials- Site Number : 8401149
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research- Site Number : 8401158
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology- Site Number : 8401076
state: Arkansas
city: Encino
country: United States
facility: Encino Research Center- Site Number : 8401042
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology- Site Number : 8401025
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8401018
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research- Site Number : 8401102
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research- Site Number : 8401022
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research- Site Number : 8401027
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles- Site Number : 8401092
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center- Site Number : 8401064
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials - Northridge- Site Number : 8401080
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research - Oxnard- Site Number : 8401142
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology- Site Number : 8401043
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute- Site Number : 8401028
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center- Site Number : 8401115
state: Connecticut
city: Coral Gables
country: United States
facility: Pediatric Skin Research- Site Number : 8401198
state: Florida
city: Doral
country: United States
facility: St Jude Clinical Research- Site Number : 8401287
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center- Site Number : 8401056
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research - Hollywood- Site Number : 8401030
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group - Miami Lakes- Site Number : 8401085
state: Florida
city: Miami
country: United States
facility: Clever Medical Research- Site Number : 8401160
state: Florida
city: Miami
country: United States
facility: Florida International Research Center- Site Number : 8401091
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086
state: Florida
city: Pompano Beach
country: United States
facility: Nuline Clinical Trial Center- Site Number : 8401161
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals (GCP)- Site Number : 8401045
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida- Site Number : 8401023
state: Florida
city: Cumming
country: United States
facility: Cleaver Medical Group Dermatology- Site Number : 8401139
state: Georgia
city: Dawsonville
country: United States
facility: Cleaver Medical Group- Site Number : 8401138
state: Georgia
city: Fayetteville
country: United States
facility: First Georgia Physician Group- Site Number : 8401190
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia - Macon- Site Number : 8401034
state: Georgia
city: Thomasville
country: United States
facility: Javara Research - Thomasville- Site Number : 8401189
state: Georgia
city: Union City
country: United States
facility: Rophe Adult & Pediatric Medicine- Site Number : 8401289
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie- Site Number : 8401038
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research- Site Number : 8401015
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences- Site Number : 8401039
state: Kentucky
city: Covington
country: United States
facility: MedPharmics - Covington- Site Number : 8401137
state: Louisiana
city: Gretna
country: United States
facility: BRCR Global Gretna- Site Number : 8401243
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette- Site Number : 8401152
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
state: Massachusetts
city: Needham
country: United States
facility: Metro Boston Clinical Partners- Site Number : 8401128
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research Institute - Dearborn- Site Number : 8401012
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital- Site Number : 8401044
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Center- Site Number : 8401116
state: Michigan
city: Ypsilanti
country: United States
facility: Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
state: Michigan
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
state: Mississippi
city: Omaha
country: United States
facility: Skin Specialists- Site Number : 8401068
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research- Site Number : 8401054
state: Nevada
city: Hoboken
country: United States
facility: Care Access - Hoboken- Site Number : 8401132
state: New Jersey
city: New York
country: United States
facility: Equity Medical- Site Number : 8401239
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8401129
state: New York
city: New York
country: United States
facility: Sadick Research Group - New York - Park Avenue- Site Number : 8401050
state: New York
city: New York
country: United States
facility: OptiSkin- Site Number : 8401163
state: New York
city: Fargo
country: United States
facility: AXIS Clinicals - Fargo- Site Number : 8401196
state: North Dakota
city: Bexley
country: United States
facility: Bexley Dermatology Research- Site Number : 8401051
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Springdale- Site Number : 8401153
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center- Site Number : 8401237
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center- Site Number : 8401017
state: Oregon
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8401031
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company- Site Number : 8401041
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia- Site Number : 8401193
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting- Site Number : 8401147
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics- Site Number : 8401166
state: South Carolina
city: Spartanburg
country: United States
facility: Tribe Clinical Research - Greenville - ERN - PPDS- Site Number : 8401225
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts- Site Number : 8401059
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center- Site Number : 8401248
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center- Site Number : 8401164
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center- Site Number : 8401209
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research- Site Number : 8401182
state: Texas
city: Missouri City
country: United States
facility: Sienna Dermatology- Site Number : 8401148
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists- Site Number : 8401131
state: Texas
city: Southlake
country: United States
facility: Stryde Research - Epiphany Dermatology- Site Number : 8401185
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology - Sugar Land- Site Number : 8401061
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - Ogden Clinic- Site Number : 8401114
state: Utah
city: Layton
country: United States
facility: Tanner Clinic - Layton Antelope A- Site Number : 8401151
state: Utah
city: Arlington
country: United States
facility: Care Access - Arlington 2- Site Number : 8401134
state: Virginia
city: Norfolk
country: United States
facility: Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
state: Virginia
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320021
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320019
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320006
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320015
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320020
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320022
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320023
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320011
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320016
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320008
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320018
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320010
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Corrientes
country: Argentina
facility: Investigational Site Number : 0320012
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320013
city: Westmead
country: Australia
facility: Investigational Site Number : 0360010
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360007
state: Queensland
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360008
state: Victoria
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360006
state: Victoria
city: Traralgon
country: Australia
facility: Investigational Site Number : 0361006
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
state: Bahia
city: Vitoria
country: Brazil
facility: Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
state: Espírito Santo
city: Bequimão
country: Brazil
facility: Hospital São Domingos- Site Number : 0760028
state: Maranhão
city: Curitiba
country: Brazil
facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
state: São Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC- Site Number : 0760001
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760006
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
city: São Paulo
country: Brazil
facility: Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP- Site Number : 0760012
city: Dupnitsa
country: Bulgaria
facility: Investigational Site Number : 1002007
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1002004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002005
city: Calgary
country: Canada
facility: Investigational Site Number : 1240039
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240031
state: Alberta
city: Kelowna
country: Canada
facility: Investigational Site Number : 1240046
state: British Columbia
city: Surrey
country: Canada
facility: Investigational Site Number : 1240040
state: British Columbia
city: Surrey
country: Canada
facility: Investigational Site Number : 1240030
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240041
state: Manitoba
city: Ajax
country: Canada
facility: Investigational Site Number : 1240033
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240029
state: Ontario
city: Markham
country: Canada
facility: Investigational Site Number : 1241106
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Niagara Falls
country: Canada
facility: Investigational Site Number : 1241108
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240034
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240038
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240035
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1241107
state: Ontario
city: Québec City
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Regina
country: Canada
facility: Investigational Site Number : 1240028
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240036
state: Saskatchewan
city: Red Deer
country: Canada
facility: Investigational Site Number : 1240045
city: Talcahuano
country: Chile
facility: Investigational Site Number : 1520012
state: Biobío
city: Osorno
country: Chile
facility: Investigational Site Number : 1520009
state: Los Lagos
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520004
state: Los Ríos
city: Santiago
country: Chile
facility: Investigational Site Number : 1520013
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520008
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520014
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520010
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520011
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520015
state: Valparaíso
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520006
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560042
city: Beijing
country: China
facility: Investigational Site Number : 1560004
city: Beijing
country: China
facility: Investigational Site Number : 1560030
city: Changsha
country: China
facility: Investigational Site Number : 1560050
city: Chengdu
country: China
facility: Investigational Site Number : 1560022
city: Chengdu
country: China
facility: Investigational Site Number : 1560060
city: Chengdu
country: China
facility: Investigational Site Number : 1560068
city: Chongqing
country: China
facility: Investigational Site Number : 1560057
city: Chongqing
country: China
facility: Investigational Site Number : 1560065
city: Fuzhou
country: China
facility: Investigational Site Number : 1560043
city: Guangzhou
country: China
facility: Investigational Site Number : 1560021
city: Guangzhou
country: China
facility: Investigational Site Number : 1560025
city: Guangzhou
country: China
facility: Investigational Site Number : 1560058
city: Hangzhou
country: China
facility: Investigational Site Number : 1560044
city: Hangzhou
country: China
facility: Investigational Site Number : 1560002
city: Hangzhou
country: China
facility: Investigational Site Number : 1560006
city: Hangzhou
country: China
facility: Investigational Site Number : 1560029
city: Jinan
country: China
facility: Investigational Site Number : 1560007
city: Nanchang
country: China
facility: Investigational Site Number : 1560051
city: Ningbo
country: China
facility: Investigational Site Number : 1560024
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Shanghai
country: China
facility: Investigational Site Number : 1560005
city: Shenyang
country: China
facility: Investigational Site Number : 1560041
city: Shenyang
country: China
facility: Investigational Site Number : 1560026
city: Shenzhen
country: China
facility: Investigational Site Number : 1560064
city: Wenzhou
country: China
facility: Investigational Site Number : 1560023
city: Wuhan
country: China
facility: Investigational Site Number : 1560049
city: Wuxi
country: China
facility: Investigational Site Number : 1560003
city: Zhenjiang
country: China
facility: Investigational Site Number : 1560028
city: Kutná Hora
country: Czechia
facility: Investigational Site Number : 2032106
city: Nový Jičín
country: Czechia
facility: Investigational Site Number : 2032105
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030010
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Pilsen
country: Czechia
facility: Investigational Site Number : 2030009
city: Prague
country: Czechia
facility: Investigational Site Number : 2030008
city: Prague
country: Czechia
facility: Investigational Site Number : 2030011
city: Prague
country: Czechia
facility: Investigational Site Number : 2030006
city: Aalborg
country: Denmark
facility: Investigational Site Number : 2080002
city: Aarhus
country: Denmark
facility: Investigational Site Number : 2080001
city: Herlev
country: Denmark
facility: Investigational Site Number : 2080003
city: Antony
country: France
facility: Investigational Site Number : 2500008
city: Nice
country: France
facility: Investigational Site Number : 2500013
city: Paris
country: France
facility: Investigational Site Number : 2500003
city: Pierre-bénite
country: France
facility: Investigational Site Number : 2500006
city: Reims
country: France
facility: Investigational Site Number : 2500007
city: Romans-sur-isère
country: France
facility: Investigational Site Number : 2500010
city: Rouen
country: France
facility: Investigational Site Number : 2500012
city: Toulouse
country: France
facility: Investigational Site Number : 2500002
city: Augsburg
country: Germany
facility: Investigational Site Number : 2760020
city: Bad Bentheim
country: Germany
facility: Investigational Site Number : 2760009
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760017
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760021
city: Kiel
country: Germany
facility: Investigational Site Number : 2762208
city: Mainz
country: Germany
facility: Investigational Site Number : 2760016
city: Münster
country: Germany
facility: Investigational Site Number : 2762201
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Ahmedabad
country: India
facility: Investigational Site Number : 3560001
city: Belagavi
country: India
facility: Investigational Site Number : 3560005
city: Chandigarh
country: India
facility: Investigational Site Number : 3560004
city: Haryana
country: India
facility: Investigational Site Number : 3560006
city: Kolkata
country: India
facility: Investigational Site Number : 3560007
city: Nagpur
country: India
facility: Investigational Site Number : 3560002
city: Pune
country: India
facility: Investigational Site Number : 3560003
city: Afula
country: Israel
facility: Investigational Site Number : 3760004
city: Be'er Sheva
country: Israel
facility: Investigational Site Number : 3760005
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760006
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760002
city: Milan
country: Italy
facility: Investigational Site Number : 3800003
state: Milano
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800018
state: Milano
city: Rome
country: Italy
facility: Investigational Site Number : 3800013
state: Roma
city: Bologna
country: Italy
facility: Investigational Site Number : 3800012
city: Catania
country: Italy
facility: Investigational Site Number : 3800009
city: L'aquila
country: Italy
facility: Investigational Site Number : 3800011
city: Pisa
country: Italy
facility: Investigational Site Number : 3800008
city: Chitose
country: Japan
facility: Investigational Site Number : 3920009
state: Hokkaido
city: Obihiro
country: Japan
facility: Investigational Site Number : 3923114
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920008
state: Hokkaido
city: Kobe
country: Japan
facility: Investigational Site Number : 3920006
state: Hyogo
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920005
state: Kanagawa
city: Yokohama
country: Japan
facility: Investigational Site Number : 3923113
state: Kanagawa
city: Miyagi-gun
country: Japan
facility: Investigational Site Number : 3920010
state: Miyagi
city: Sendai
country: Japan
facility: Investigational Site Number : 3920011
state: Miyagi
city: Habikino
country: Japan
facility: Investigational Site Number : 3923109
state: Osaka
city: Sakai
country: Japan
facility: Investigational Site Number : 3923110
state: Osaka
city: Iruma
country: Japan
facility: Investigational Site Number : 3920002
state: Saitama
city: Mibu
country: Japan
facility: Investigational Site Number : 3923106
state: Tochigi
city: Chuo
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Minato
country: Japan
facility: Investigational Site Number : 3923107
state: Tokyo
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920001
state: Tokyo
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3923108
city: Kyoto
country: Japan
facility: Investigational Site Number : 3923102
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920003
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Daegu-gwangyeoksi
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number : 4100012
state: Gwangju-gwangyeoksi
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number : 4100014
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Investigational Site Number : 4100009
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Gyeongsangnam-do
city: Bupyeong-gu
country: Korea, Republic of
facility: Investigational Site Number : 4100015
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100010
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100013
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100011
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100017
state: Seoul-teukbyeolsi
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840005
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Investigational Site Number : 4840012
city: Durango
country: Mexico
facility: Investigational Site Number : 4840009
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840003
city: Lublin
country: Poland
facility: Investigational Site Number : 6160004
state: Lubelskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6160002
state: Lódzkie
city: Krakow
country: Poland
facility: Investigational Site Number : 6162406
state: Malopolskie
city: Tarnow
country: Poland
facility: Investigational Site Number : 6160010
state: Malopolskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160009
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160007
state: Mazowieckie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160003
state: Slaskie
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200005
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200004
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200001
city: Porto
country: Portugal
facility: Investigational Site Number : 6200003
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100010
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100009
city: Durban
country: South Africa
facility: Investigational Site Number : 7100012
city: Durban
country: South Africa
facility: Investigational Site Number : 7100001
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100015
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100007
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100003
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240012
state: Las Palmas
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240015
state: Navarra
city: Bilbao
country: Spain
facility: Investigational Site Number : 7240008
state: Pais Vasco
city: Vigo
country: Spain
facility: Investigational Site Number : 7240014
state: Pontevedra [Pontevedra]
city: Seville
country: Spain
facility: Investigational Site Number : 7240020
state: Sevilla
city: Burjassot
country: Spain
facility: Investigational Site Number : 7240023
state: Valencia
city: Alicante
country: Spain
facility: Investigational Site Number : 7242505
city: Granada
country: Spain
facility: Investigational Site Number : 7240019
city: Granada
country: Spain
facility: Investigational Site Number : 7240018
city: Madrid
country: Spain
facility: Investigational Site Number : 7242503
city: Alvsjo
country: Sweden
facility: Investigational Site Number : 7520006
city: Orebro
country: Sweden
facility: Investigational Site Number : 7520001
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1583201
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1583202
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580003
city: Antalya
country: Turkey
facility: Investigational Site Number : 7920001
city: Gaziantep
country: Turkey
facility: Investigational Site Number : 7920008
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920009
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920004
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920007
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Hampshire
city: London
country: United Kingdom
facility: Investigational Site Number : 8262601
state: London, City Of
city: London
country: United Kingdom
facility: Investigational Site Number : 8262602
state: London, City Of
city: Glasgow
country: United Kingdom
facility: Investigational Site Number : 8260006
city: Leicester
country: United Kingdom
facility: Investigational Site Number : 8260004
Study officials:
References: