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A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (ROCKET-Ignite)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rocatinlimab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 6 months
  • History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
  • EASI score ≥16
  • vIGA-AD score ≥3
  • ≥10% body surface area (BSA) of AD involvement
  • Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

  • Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

  • Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

    • Systemic corticosteroids
    • Systemic immunosuppressants
    • Anti-pruritic agents
    • Phototherapy
    • Janus kinase inhibitors

  • Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

    • TCS
    • TCI
    • Topical phosphodiesterase type 4 inhibitors
    • Other topical immunosuppressive agents

Sites / Locations

  • Cahaba Dermatology and Skin Health CenterRecruiting
  • Alliance Dermatology and Mohs CenterRecruiting
  • Anaheim Clinical TrialsRecruiting
  • First OC DermatologyRecruiting
  • Long Beach Research Institute, LLCRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Dermatology Research AssociatesRecruiting
  • Cura Clinical ResearchRecruiting
  • Immunoe Health CentersRecruiting
  • Skin Care Research IncorporatedRecruiting
  • Palm Beach Dermatology GroupRecruiting
  • Global Research AssociatesRecruiting
  • Savin Medical Group LLCRecruiting
  • Healthy Life ResearchRecruiting
  • Kirsch DermatologyRecruiting
  • Pure Skin Dermatology and AestheticsRecruiting
  • Industrial Medicine Associates Ima Clinical Research IncRecruiting
  • Genesis Clinical Research LLCRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • DeNova ResearchRecruiting
  • Dundee DermatologyRecruiting
  • The Indiana Clinical Trials Center PCRecruiting
  • Institute for Asthma and AllergyRecruiting
  • Continental Clinical Solutions, LLCRecruiting
  • Henry Ford Health SystemRecruiting
  • Onyx Clinical ResearchRecruiting
  • Dermatology and Skin Cancer Center of Lees SummitRecruiting
  • Jubilee Clinical Research IncRecruiting
  • Allcutis Research, Llc - PortsmouthRecruiting
  • Continental Clinical Solutions - Cherry HillRecruiting
  • Industrial Medicine Associates Ima Clinical Research IncRecruiting
  • Sadick Research GroupRecruiting
  • Dermatology Specialists of CharlotteRecruiting
  • Onsite Clinical SolutionsRecruiting
  • Wilmington Dermatology CenterRecruiting
  • The Skin Surgery Center for Clinical ResearchRecruiting
  • Optima ResearchRecruiting
  • ClinOhio Research ServicesRecruiting
  • Unity Clinical ResearchRecruiting
  • Dermatology Research Center of Oklahoma, PLLCRecruiting
  • Essential Medical Research, LLCRecruiting
  • Oregon Health and Science UniversityRecruiting
  • DermDox Dermatology, LLCRecruiting
  • Cumberland Skin CenterRecruiting
  • Dermatology Treatment and Research Center PARecruiting
  • The Woodlands Dermatology AssociatesRecruiting
  • Education and Research Foundation IncRecruiting
  • Frontier Derm PartnersRecruiting
  • West Virginia Research InstituteRecruiting
  • Cinme - Centro de Investigaciones MetabolicasRecruiting
  • Fundacion RespirarRecruiting
  • Hospital Universitario AustralRecruiting
  • Centro Dermatológico SchejtmanRecruiting
  • Conexa Investigacion Clínica S.A.Recruiting
  • InAER - Investigaciones en Alergia y Enfermedades RespiratoriasRecruiting
  • Instituto de Neumonologia y DermatologiaRecruiting
  • Fundacion Estudios ClinicosRecruiting
  • Instituto de Diagnostico ABCRecruiting
  • Hospital de Clinicas de Porto AlegreRecruiting
  • UPECLIN - Unidade de Pesquisa Clinica da Faculdade de Medicina de BotucatuRecruiting
  • Hospital e Maternidade Doutor Christovao da GamaRecruiting
  • Fundacao do ABC - Centro Universitario FMABCRecruiting
  • Consultoria Medica e Pesquisa Clinica - CMPCRecruiting
  • IBPClin Instituto Brasil de Pesquisa ClinicaRecruiting
  • Alberta Derma Surgery CentreRecruiting
  • Vida Clinical ResearchRecruiting
  • CCA Medical Research CorporationRecruiting
  • SimcoDerm Medical and Surgical Dermatology CentreRecruiting
  • LEADER ResearchRecruiting
  • DermEdge Research IncorporatedRecruiting
  • Canadian Dermatology CentreRecruiting
  • Gordon Sussman Clinical Research IncorporatedRecruiting
  • Oak Ridges Aesthetics CentreRecruiting
  • Innovaderm Research IncRecruiting
  • Skinsense Medical ResearchRecruiting
  • Recherche Clinique Sigma Inc.Recruiting
  • Nanyang First Peoples HospitalRecruiting
  • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of MedicineRecruiting
  • Peking University Peoples HospitalRecruiting
  • Special Hospital for Medical Rehabilitation NaftalanRecruiting
  • Sestre milosrdnice University Hospital CenterRecruiting
  • University Hospital Centre ZagrebRecruiting
  • Dermamedica, sroRecruiting
  • CCR Ostrava sroRecruiting
  • CCR Czech asRecruiting
  • Clintrial sroRecruiting
  • CCR Prague sroRecruiting
  • Fakultni nemocnice BulovkaRecruiting
  • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem ozRecruiting
  • Charite - Universitaetsmedizin Berlin, Campus MitteRecruiting
  • Dermatologische Gemeinschaftspraxis-MahlowRecruiting
  • Hautarztpraxis Dr Niesmann und Dr OthlinghausRecruiting
  • Rosenpark Research GmbHRecruiting
  • Universitaetsklinikum DresdenRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Institute for Health Services Research in Dermatology and NursingRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Hautarztpraxis Dres Leitz und KollegenRecruiting
  • Universitaetsklinikum TuebingenRecruiting
  • CentroDerm GmbHRecruiting
  • Athens Naval HospitalRecruiting
  • Thoracic General Hospital Of Athens SotiriaRecruiting
  • University General Hospital AttikonRecruiting
  • Andreas Syngros Hospital Of Venereal And Dermatological DiseasesRecruiting
  • University General Hospital of IoanninaRecruiting
  • General University Hospital of LarissaRecruiting
  • Papageorgiou General HospitalRecruiting
  • Medmare BtRecruiting
  • Universita degli Studi Gabriele D Annunzio di Chieti e PescaraRecruiting
  • Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting
  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della MisericordiaRecruiting
  • Azienda Ospedaliera Policlinico Umberto IRecruiting
  • Azienda Ospedaliera Citta della Salute e della Scienza di TorinoRecruiting
  • Aichi Medical University HospitalRecruiting
  • Japan Community Healthcare Organization Chukyo HospitalRecruiting
  • Central ClinicRecruiting
  • Nagoya City University HospitalRecruiting
  • Fukuoka University HospitalRecruiting
  • Matsuo ClinicRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Asahikawa City HospitalRecruiting
  • Tokyo Medical University Ibaraki Medical CenterRecruiting
  • Kaji Dermatology ClinicRecruiting
  • Iwate Medical University Uchimaru Medical CenterRecruiting
  • Takeoka Dermatology ClinicRecruiting
  • Nippon Medical School Musashikosugi HospitalRecruiting
  • University Hospital Kyoto Prefectural University of MedicineRecruiting
  • Rakuwakai Otowa HospitalRecruiting
  • Mochida Dermatology ClinicRecruiting
  • Dokkyo Medical University HospitalRecruiting
  • Teikyo University HospitalRecruiting
  • Nihon University Itabashi HospitalRecruiting
  • Outpatient clinic Veselibas Centrs 4Recruiting
  • Outpatient clinic Veselibascentrs 4Recruiting
  • Smite Aija practice in dermatology and venerologyRecruiting
  • PT&RRecruiting
  • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczyRecruiting
  • Centrum Medyczne Angelius ProvitaRecruiting
  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz SpzooRecruiting
  • Twoja przychodnia NcmRecruiting
  • Twoja przychodnia PcmRecruiting
  • Alergo-Med Specjalistyczna Przychodnia Lekarska SpzooRecruiting
  • Royalderm Agnieszka NawrockaRecruiting
  • Dermatologiczna Praktyka Lekarska Michał Torz Dermaceum Centrum Badań KlinicznychRecruiting
  • Hospital Cuf DescobertasRecruiting
  • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro HispanoRecruiting
  • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo AntonioRecruiting
  • Clinical Research of Puerto RicoRecruiting
  • Fakultna Nemocnica s poliklinikou FD Roosevelta Banska BystricaRecruiting
  • Derma therapy, spol s roRecruiting
  • Sanare spol sroRecruiting
  • Kaderma Majtan, sroRecruiting
  • Fakultna nemocnica TrnavaRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Miguel ServetRecruiting
  • Hospital Universitario de Gran Canaria Doctor NegrinRecruiting
  • Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Universitario Quironsalud MadridRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital Universitario Infanta LeonorRecruiting
  • Hospital Clinico Universitario de SantiagoRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2

Rocatinlimab Dose 2 Q4W + loading dose at Week 2

Placebo Q4W+ loading dose at Week 2

Outcomes

Primary Outcome Measures

Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24
Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24

Secondary Outcome Measures

Achievement of ≥75% reduction from baseline in EASI score at Week 16
Achievement of a vIGA-AD score of 0 or 1 from baseline at week 16
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
Achievement of ≥90% reduction from baseline in EASI score at Week 24
Change from baseline in DLQI score at week 24
Change from baseline in weekly average of daily AD skin pain NRS score at week 24
Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24
Achievement of ≥ 4-point reduction from baseline in DLQI score at week 24 in subjects with baseline DLQI score ≥ 4
Achievement of ≥ 4-point reduction from baseline in POEM score at week 24 in subjects with baseline POEM score ≥ 4
Change from baseline in POEM score at week 24
Change from baseline in weekly average of daily AD skin pain NRS score at week 16
Change from baseline in weekly average of daily sleep disturbance NRS score at week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8
Change from baseline in HADS-anxiety subscale score at week 24
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8
Change from baseline in HADS-depression subscale score at week 24
Achievement of Facial AD Severity Score of Clear at week 24 for subjects with facial AD at baseline
Achievement of Hand AD Severity Score of Clear at week 24 for subjects with hand AD at baseline
Achievement of Genital AD Severity Score of Clear at week 24 for subjects with genital AD at baseline
Change from baseline in weekly average of daily worst pruritus NRS score at week 16
Change from baseline in weekly average of daily worst pruritus NRS score at week 24
Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at week 16
Change from baseline in SCORAD itch VAS score at week 24
Achievement of ≥ 8.7-point reduction from baseline in SCORAD score at week 24 in participants with baseline SCORAD score ≥ 8.7

Full Information

First Posted
May 24, 2022
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05398445
Brief Title
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
Acronym
ROCKET-Ignite
Official Title
A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
January 6, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Rocatinlimab Dose 2 Q4W + loading dose at Week 2
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Placebo Q4W+ loading dose at Week 2
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451
Intervention Description
Participants will receive Rocatinlimab subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a placebo subcutaneously.
Primary Outcome Measure Information:
Title
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24
Time Frame
Baseline, Week 24
Title
Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Achievement of ≥75% reduction from baseline in EASI score at Week 16
Time Frame
Baseline, Week 16
Title
Achievement of a vIGA-AD score of 0 or 1 from baseline at week 16
Time Frame
Baseline, Week 16
Title
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
Time Frame
Baseline, Week 16
Title
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
Time Frame
Baseline, Week 24
Title
Achievement of ≥90% reduction from baseline in EASI score at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in DLQI score at week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in weekly average of daily AD skin pain NRS score at week 24
Time Frame
Baseline, Week 24
Title
Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24
Time Frame
Baseline, Week 24
Title
Achievement of ≥ 4-point reduction from baseline in DLQI score at week 24 in subjects with baseline DLQI score ≥ 4
Time Frame
Baseline, Week 24
Title
Achievement of ≥ 4-point reduction from baseline in POEM score at week 24 in subjects with baseline POEM score ≥ 4
Time Frame
Baseline, Week 24
Title
Change from baseline in POEM score at week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in weekly average of daily AD skin pain NRS score at week 16
Time Frame
Baseline, Week 16
Title
Change from baseline in weekly average of daily sleep disturbance NRS score at week 24
Time Frame
Baseline, Week 24
Title
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8
Time Frame
Baseline, Week 24
Title
Change from baseline in HADS-anxiety subscale score at week 24
Time Frame
Baseline, Week 24
Title
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8
Time Frame
Baseline, Week 24
Title
Change from baseline in HADS-depression subscale score at week 24
Time Frame
Baseline, Week 24
Title
Achievement of Facial AD Severity Score of Clear at week 24 for subjects with facial AD at baseline
Time Frame
Baseline, Week 24
Title
Achievement of Hand AD Severity Score of Clear at week 24 for subjects with hand AD at baseline
Time Frame
Baseline, Week 24
Title
Achievement of Genital AD Severity Score of Clear at week 24 for subjects with genital AD at baseline
Time Frame
Baseline, Week 24
Title
Change from baseline in weekly average of daily worst pruritus NRS score at week 16
Time Frame
Baseline, Week 16
Title
Change from baseline in weekly average of daily worst pruritus NRS score at week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at week 16
Time Frame
Baseline, Week 16
Title
Change from baseline in SCORAD itch VAS score at week 24
Time Frame
Baseline, Week 24
Title
Achievement of ≥ 8.7-point reduction from baseline in SCORAD score at week 24 in participants with baseline SCORAD score ≥ 8.7
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI]). EASI score ≥16 vIGA-AD score ≥3 ≥10% body surface area (BSA) of AD involvement Worst pruritus numerical rating scale ≥ 4 Exclusion Criteria: Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: Systemic corticosteroids Systemic immunosuppressants Phototherapy Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS of any potency TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology and Skin Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Dermatology and Mohs Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Research Institute, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Cura Clinical Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Immunoe Health Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research Incorporated
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Palm Beach Dermatology Group
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Research Associates
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Name
Savin Medical Group LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthy Life Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Kirsch Dermatology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Pure Skin Dermatology and Aesthetics
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Industrial Medicine Associates Ima Clinical Research Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Individual Site Status
Recruiting
Facility Name
The Indiana Clinical Trials Center PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Institute for Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Continental Clinical Solutions, LLC
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Onyx Clinical Research
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology and Skin Cancer Center of Lees Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Individual Site Status
Recruiting
Facility Name
Jubilee Clinical Research Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Allcutis Research, Llc - Portsmouth
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
Continental Clinical Solutions - Cherry Hill
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Recruiting
Facility Name
Industrial Medicine Associates Ima Clinical Research Inc
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Individual Site Status
Recruiting
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Onsite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Individual Site Status
Recruiting
Facility Name
The Skin Surgery Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Optima Research
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinOhio Research Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Center of Oklahoma, PLLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
Individual Site Status
Recruiting
Facility Name
Essential Medical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
DermDox Dermatology, LLC
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Skin Center
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Treatment and Research Center PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
The Woodlands Dermatology Associates
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Education and Research Foundation Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Derm Partners
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia Research Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Name
Cinme - Centro de Investigaciones Metabolicas
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Respirar
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Austral
City
Derqui, Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Dermatológico Schejtman
City
San Miguel
State/Province
Buenos Aires
ZIP/Postal Code
1663
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Conexa Investigacion Clínica S.A.
City
Caba
State/Province
Distrito Federal
ZIP/Postal Code
C1012AAY
Country
Argentina
Individual Site Status
Recruiting
Facility Name
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Neumonologia y Dermatologia
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Estudios Clinicos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Diagnostico ABC
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UPECLIN - Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital e Maternidade Doutor Christovao da Gama
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09030-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Consultoria Medica e Pesquisa Clinica - CMPC
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Individual Site Status
Recruiting
Facility Name
IBPClin Instituto Brasil de Pesquisa Clinica
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Alberta Derma Surgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vida Clinical Research
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6H 4J8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CCA Medical Research Corporation
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Individual Site Status
Recruiting
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEADER Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
DermEdge Research Incorporated
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Canadian Dermatology Centre
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 0A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Gordon Sussman Clinical Research Incorporated
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Oak Ridges Aesthetics Centre
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4E 4L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Skinsense Medical Research
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Recherche Clinique Sigma Inc.
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Nanyang First Peoples Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473002
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Peoples Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Special Hospital for Medical Rehabilitation Naftalan
City
Ivanic-Grad
ZIP/Postal Code
10310
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Sestre milosrdnice University Hospital Center
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Dermamedica, sro
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Ostrava sro
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Czech as
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clintrial sro
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Prague sro
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Bulovka
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologische Gemeinschaftspraxis-Mahlow
City
Blankenfelde-Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hautarztpraxis Dr Niesmann und Dr Othlinghaus
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rosenpark Research GmbH
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45174
Country
Germany
Individual Site Status
Recruiting
Facility Name
Institute for Health Services Research in Dermatology and Nursing
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hautarztpraxis Dres Leitz und Kollegen
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
CentroDerm GmbH
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany
Individual Site Status
Recruiting
Facility Name
Athens Naval Hospital
City
Athens
ZIP/Postal Code
11521
Country
Greece
Individual Site Status
Recruiting
Facility Name
Thoracic General Hospital Of Athens Sotiria
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital Attikon
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
City
Athens
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Name
General University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Papageorgiou General Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Individual Site Status
Recruiting
Facility Name
Medmare Bt
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aichi Medical University Hospital
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Healthcare Organization Chukyo Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Central Clinic
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-0821
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsuo Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-0373
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Asahikawa City Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kaji Dermatology Clinic
City
Nonoichi-shi
State/Province
Ishikawa
ZIP/Postal Code
921-8801
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Uchimaru Medical Center
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takeoka Dermatology Clinic
City
Marugame-shi
State/Province
Kagawa
ZIP/Postal Code
763-0074
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Musashikosugi Hospital
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mochida Dermatology Clinic
City
Izumiotsu-shi
State/Province
Osaka
ZIP/Postal Code
595-0025
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Outpatient clinic Veselibas Centrs 4
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Outpatient clinic Veselibascentrs 4
City
Riga
ZIP/Postal Code
LV-1013
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Smite Aija practice in dermatology and venerology
City
Talsi
ZIP/Postal Code
3201
Country
Latvia
Individual Site Status
Recruiting
Facility Name
PT&R
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
City
Gdansk
ZIP/Postal Code
80-280
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
City
Malbork
ZIP/Postal Code
82-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja przychodnia Ncm
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja przychodnia Pcm
City
Poznan
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermatologiczna Praktyka Lekarska Michał Torz Dermaceum Centrum Badań Klinicznych
City
Wroclaw
ZIP/Postal Code
50-450
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Cuf Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Clinical Research of Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Derma therapy, spol s ro
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Sanare spol sro
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Kaderma Majtan, sro
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas de Gran Canaria
State/Province
Canarias
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de LLobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

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