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A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

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

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 12 to < 18 years at Day 1. Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent. Body weight ≥ 40 kg at screening. History of inadequate response to TCS of medium to higher potency (with or without TCI). EASI score ≥ 12 at initial screening. EASI score ≥ 16 at Day 1. vIGA-AD score ≥ 3. ≥10% body surface area of AD involvement. Worst pruritus NRS ≥ 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 Non-biologic, non-targeted systemic immunosuppressants Phototherapy Oral or Topical 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 4 inhibitors Other topical immunosuppressive agents

Sites / Locations

  • Clinical Research Center of AlabamaRecruiting
  • Cahaba Dermatology and Skin Health CenterRecruiting
  • Arkansas Research Trials, LLCRecruiting
  • Center for Dermatology Clinical Research IncRecruiting
  • Avance Clinical TrialsRecruiting
  • Cura Clinical ResearchRecruiting
  • Integrative Skin Science and ResearchRecruiting
  • University of California at Davis Medical CenterRecruiting
  • Clinical Science InstituteRecruiting
  • Cura Clinical Research Sherman OaksRecruiting
  • Velocity Clinical Research - DenverRecruiting
  • Academic Alliance in Dermatology - Saint Petersburg OfficeRecruiting
  • Life Clinical TrialsRecruiting
  • Palm Beach Dermatology GroupRecruiting
  • Angels Clinical Research InstituteRecruiting
  • Direct Helpers Research CenterRecruiting
  • Glick Skin InstituteRecruiting
  • Savin Medical Group LLCRecruiting
  • Miami Clinical ResearchRecruiting
  • Optimal Research Sites, LLCRecruiting
  • Clinical Associates of Orlando Limited Liability CompanyRecruiting
  • Clinical Research InvestmentsRecruiting
  • Advanced Medical Research PCRecruiting
  • Divine Dermatology and Aesthetics, LLCRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • Velocity Clinical Research - BoiseRecruiting
  • NorthShore University HealthSystem Clinical Trials CenterRecruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • Southern Indiana Clinical TrialsRecruiting
  • The Indiana Clinical Trials Center PCRecruiting
  • Kentucky Advanced Medical Research LLCRecruiting
  • Industrial Medicine Associates Clinical Research Advanced Dermatology CareRecruiting
  • Derm Associates, PCRecruiting
  • Oakland Hills DermatologyRecruiting
  • Henry Ford Medical Center - New Center OneRecruiting
  • Onyx Clinical ResearchRecruiting
  • Saint Louis UniversityRecruiting
  • Somnos Clinical ResearchRecruiting
  • Skin Cancer and Dermatology InstituteRecruiting
  • Allcutis ResearchRecruiting
  • Yeshiva University - Montefiore Medical CenterRecruiting
  • Ace Clinical TrialsRecruiting
  • Empire DermatologyRecruiting
  • Forest Hills Dermatology GroupRecruiting
  • Optima ResearchRecruiting
  • Apex DermatologyRecruiting
  • Epic Medical Research - OklahomaRecruiting
  • Lynn Health Science InstituteRecruiting
  • Dermatology and Aesthetics of OklahomaRecruiting
  • Dermatology Research Center of Oklahoma, PLLCRecruiting
  • Essential Medical Research, LLCRecruiting
  • Velocity Clinical Research - Grants PassRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Paddington Testing Company IncRecruiting
  • Medical University of South CarolinaRecruiting
  • National Allergy and Asthma Research, LLCRecruiting
  • Coastal Pediatric ResearchRecruiting
  • US Dermatology Partners Cedar ParkRecruiting
  • Studies in DermatologyRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Tranquil Clinical ResearchRecruiting
  • Sante Clinical ResearchRecruiting
  • sms Clinical Research Limited Liability CompanyRecruiting
  • Texas Dermatology and Laser SpecialistsRecruiting
  • Tanner ClinicRecruiting
  • Northwest Clinical Research CenterRecruiting
  • Hopital ErasmeRecruiting
  • Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
  • Dermatologie MaldegemRecruiting
  • Clínica IBIS - Medicina, Reumatologia e Dermatologia LTDARecruiting
  • Irmandade da Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital de Base de Sao Jose do Rio PretoRecruiting
  • IBPClin Instituto Brasil de Pesquisa ClinicaRecruiting
  • Lynderm Research IncRecruiting
  • Allergy Research Canada IncorporatedRecruiting
  • XLR8 Medical Research, IncorporatedRecruiting
  • Skinsense Medical ResearchRecruiting
  • Nanyang First Peoples HospitalRecruiting
  • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of MedicineRecruiting
  • Peking University Peoples HospitalRecruiting
  • Hunan Childrens HospitalRecruiting
  • Hopital Prive d AntonyRecruiting
  • CHRU Brest Hôpital MorvanRecruiting
  • Hôpital Saint-JosephRecruiting
  • Centre Hospitalier Universitaire de Rennes - Hopital PontchaillouRecruiting
  • Centre Hospitalier Universitaire de Rouen - Hôpital Charles NicolleRecruiting
  • Centre Hospitalier Universitaire de Toulouse, Hopital LarreyRecruiting
  • Fachklinik Bad BentheimRecruiting
  • Rosenpark Research GmbHRecruiting
  • Universitaetsklinikum DresdenRecruiting
  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am MainRecruiting
  • Velocity Clinical ResearchRecruiting
  • Johannes Gutenberg Universitaet MainzRecruiting
  • Athens Naval HospitalRecruiting
  • Athens General Childrens Hospital Panagioti And Aglaia KyriakouRecruiting
  • Thoracic General Hospital Of Athens SotiriaRecruiting
  • Ippokratio General Hospital of ThessalonikiRecruiting
  • Derma-B Egeszsegugyi es Szolgaltato KftRecruiting
  • Somogy Megyei Kaposi Mor Oktato KorhazRecruiting
  • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di TorinoRecruiting
  • Central ClinicRecruiting
  • Miyata Dermatology ClinicRecruiting
  • Matsuo ClinicRecruiting
  • Asahikawa City HospitalRecruiting
  • Takagi Dermatological Clinic BranchRecruiting
  • Yoshimura Child ClinicRecruiting
  • Katahira Dermatology Urology ClinicRecruiting
  • Nomura Dermatology ClinicRecruiting
  • Yokohama City Minato Red Cross HospitalRecruiting
  • Jouzan Hihuka Hinyoukika ClinicRecruiting
  • Suizenji Dermatology ClinicRecruiting
  • Yoshioka Dermatology ClinicRecruiting
  • Dermatology and Ophthalmology Kume ClinicRecruiting
  • Hamamatsu University HospitalRecruiting
  • NTT Medical Center TokyoRecruiting
  • Korea University Ansan HospitalRecruiting
  • Nowon Eulji Medical Center, Eulji UniversityRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • National Medical CenterRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • The Catholic Univ of Korea Seoul St Marys HospitalRecruiting
  • Chung-Ang University HospitalRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Ewha Womans University Seoul HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical CenterRecruiting
  • AppleTreeClinics Network SpzooRecruiting
  • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum MedyczneRecruiting
  • Alergo-Med Specjalistyczna Przychodnia Lekarska SpzooRecruiting
  • Klinika Osipowicz and Turkowski Sp zooRecruiting
  • High Med Przychodnia SpecjalistycznaRecruiting
  • Royalderm Agnieszka NawrockaRecruiting
  • Clinical Research of Puerto RicoRecruiting
  • Dr. Leventer Centre: Clinică Dermatologie BucureștiRecruiting
  • Derma ClujRecruiting
  • Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"Recruiting
  • Hospital Sant Joan de DeuRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario La PazRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: Dose 1

Arm B: Dose 2

Arm C: Placebo

Arm D: Open-Label Dose 1

Arm Description

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.

Outcomes

Primary Outcome Measures

Achievement of vIGA-AD 0/1 at Week 24
Achievement of EASI 75 at Week 24

Secondary Outcome Measures

Achievement of EASI 75 at Week 16
Achievement of a vIGA-AD 0/1 at Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric 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 (EASI 90) at Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Achievement of a vIGA-AD Score of 1 with presence of only barely perceptible erythema or vIGA-AD Score of 0 at Week 24
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 of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Subjects with Baseline DLQI ≥ 4 (Children's Dermatology Life Quality Index [CDLQI] in Subjects < 16 Years of Age at Screening)
Change From Baseline in DLQI or CDLQI Score at Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (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 Sleep Disturbance NRS Score at Week 24
Achievement of a 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 a 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 a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Subjects with Baseline SCORAD Score ≥ 8.7

Full Information

First Posted
January 20, 2023
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05704738
Brief Title
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)
Acronym
ROCKET-ASTRO
Official Title
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
September 18, 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 and combination therapy treatment in adolescent subjects.

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
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Dose 1
Arm Type
Experimental
Arm Description
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).
Arm Title
Arm B: Dose 2
Arm Type
Experimental
Arm Description
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Arm Title
Arm C: Placebo
Arm Type
Experimental
Arm Description
Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Arm Title
Arm D: Open-Label Dose 1
Arm Type
Experimental
Arm Description
Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Achievement of vIGA-AD 0/1 at Week 24
Time Frame
Baseline and Week 24
Title
Achievement of EASI 75 at Week 24
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Achievement of EASI 75 at Week 16
Time Frame
Baseline and Week 16
Title
Achievement of a vIGA-AD 0/1 at Week 16
Time Frame
Baseline and Week 16
Title
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Subjects with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Time Frame
Baseline and 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 and Week 24
Title
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Time Frame
Baseline and Week 24
Title
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a vIGA-AD Score of 1 with presence of only barely perceptible erythema or vIGA-AD Score of 0 at Week 24
Time Frame
Baseline and Week 24
Title
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Time Frame
Baseline to Week 16
Title
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Time Frame
Baseline to Week 24
Title
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16
Time Frame
Baseline to Week 16
Title
Change From Baseline in SCORAD Itch VAS Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Subjects with Baseline DLQI ≥ 4 (Children's Dermatology Life Quality Index [CDLQI] in Subjects < 16 Years of Age at Screening)
Time Frame
Baseline and Week 24
Title
Change From Baseline in DLQI or CDLQI Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Subjects with Baseline POEM Score ≥ 4
Time Frame
Baseline and Week 24
Title
Change From Baseline in POEM Score at Week 24
Time Frame
Baseline to Week 24
Title
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a 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 and Week 24
Title
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Subjects with Baseline HADS-depression Subscale Score ≥ 8
Time Frame
Baseline and Week 24
Title
Change From Baseline in HADS-depression Subscale Score at Week 24
Time Frame
Baseline to Week 24
Title
Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Subjects with Baseline SCORAD Score ≥ 8.7
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 12 to < 18 years at Day 1. Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent. Body weight ≥ 40 kg at screening. History of inadequate response to TCS of medium to higher potency (with or without TCI). EASI score ≥ 12 at initial screening. EASI score ≥ 16 at Day 1. vIGA-AD score ≥ 3. ≥10% body surface area of AD involvement. Worst pruritus NRS ≥ 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 Non-biologic, non-targeted systemic immunosuppressants Phototherapy Oral or Topical 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 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
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
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
Arkansas Research Trials, LLC
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Dermatology Clinical Research Inc
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Avance Clinical Trials
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Individual Site Status
Recruiting
Facility Name
Cura Clinical Research
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California at Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Cura Clinical Research Sherman Oaks
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Recruiting
Facility Name
Academic Alliance in Dermatology - Saint Petersburg Office
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
Life Clinical Trials
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
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
Angels Clinical Research Institute
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Glick Skin Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
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
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimal Research Sites, LLC
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Associates of Orlando Limited Liability Company
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Investments
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Divine Dermatology and Aesthetics, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Individual Site Status
Recruiting
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706-1345
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem Clinical Trials Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Indiana Clinical Trials
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
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
Kentucky Advanced Medical Research LLC
City
Murray
State/Province
Kentucky
ZIP/Postal Code
42071
Country
United States
Individual Site Status
Recruiting
Facility Name
Industrial Medicine Associates Clinical Research Advanced Dermatology Care
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Name
Derm Associates, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Oakland Hills Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center - New Center One
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
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Name
Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Cancer and Dermatology Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Name
Allcutis Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
Yeshiva University - Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Ace Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11211
Country
United States
Individual Site Status
Recruiting
Facility Name
Empire Dermatology
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11374
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
Apex Dermatology
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research - Oklahoma
City
Chickasha
State/Province
Oklahoma
ZIP/Postal Code
73018
Country
United States
Individual Site Status
Recruiting
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology and Aesthetics of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
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
Velocity Clinical Research - Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
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
Paddington Testing Company Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
National Allergy and Asthma Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Recruiting
Facility Name
US Dermatology Partners Cedar Park
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Name
Studies in Dermatology
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Tranquil Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Individual Site Status
Recruiting
Facility Name
Sante Clinical Research
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Individual Site Status
Recruiting
Facility Name
sms Clinical Research Limited Liability Company
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
Tanner Clinic
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Dermatologie Maldegem
City
Maldegem
ZIP/Postal Code
9990
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clínica IBIS - Medicina, Reumatologia e Dermatologia LTDA
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41820-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
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
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Allergy Research Canada Incorporated
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2H 1H5
Country
Canada
Individual Site Status
Recruiting
Facility Name
XLR8 Medical Research, Incorporated
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8T 1E6
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
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
Hunan Childrens Hospital
City
Changsha
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Name
Hopital Prive d Antony
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Brest Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint-Joseph
City
Marseille Cedex 8
ZIP/Postal Code
13285
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
ZIP/Postal Code
48455
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
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Gutenberg Universitaet Mainz
City
Mainz
ZIP/Postal Code
55101
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
Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
City
Athens
ZIP/Postal Code
11527
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
Ippokratio General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Name
Derma-B Egeszsegugyi es Szolgaltato Kft
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
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
Miyata Dermatology Clinic
City
Matsudo-shi
State/Province
Chiba
ZIP/Postal Code
271-0092
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
Asahikawa City Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takagi Dermatological Clinic Branch
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yoshimura Child Clinic
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
674-0068
Country
Japan
Individual Site Status
Recruiting
Facility Name
Katahira Dermatology Urology Clinic
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nomura Dermatology Clinic
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City Minato Red Cross Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jouzan Hihuka Hinyoukika Clinic
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-0066
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suizenji Dermatology Clinic
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0950
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yoshioka Dermatology Clinic
City
Neyagawa-shi
State/Province
Osaka
ZIP/Postal Code
572-0838
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dermatology and Ophthalmology Kume Clinic
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamamatsu University Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital
City
Ansansi, Gyeonggido
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Medical Center
City
Seoul
ZIP/Postal Code
04564
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic Univ of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Seoul Hospital
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Name
AppleTreeClinics Network Spzoo
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Individual Site Status
Recruiting
Facility Name
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
City
Lodz
ZIP/Postal Code
91-495
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
Klinika Osipowicz and Turkowski Sp zoo
City
Warszawa
ZIP/Postal Code
00-716
Country
Poland
Individual Site Status
Recruiting
Facility Name
High Med Przychodnia Specjalistyczna
City
Warszawa
ZIP/Postal Code
01-817
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
Clinical Research of Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Dr. Leventer Centre: Clinică Dermatologie București
City
Bucharest
ZIP/Postal Code
011216
Country
Romania
Individual Site Status
Recruiting
Facility Name
Derma Cluj
City
Cluj-Napoca
ZIP/Postal Code
400105
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"
City
Cluj-Napoca
ZIP/Postal Code
400431
Country
Romania
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
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

Learn more about this trial

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

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