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A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

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, Eczema, Rocatinlimab, KHK4083

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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS of medium or higher potency (with or without 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 TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Sites / Locations

  • The University of Alabama at BirminghamRecruiting
  • Medical Dermatology SpecialistsRecruiting
  • Southwest Skin SpecialistsRecruiting
  • US Dermatology Partners Sun City WestRecruiting
  • Arkansas Research Trials, LLCRecruiting
  • Kern Research IncRecruiting
  • Keck Medicine of University of Southern CaliforniaRecruiting
  • Wallace Medical Group IncRecruiting
  • Antelope Valley Clinical TrialsRecruiting
  • University of California at Davis Medical CenterRecruiting
  • Kaiser Permanente South Sacramento Medical CenterRecruiting
  • Acclaim Clinical ResearchRecruiting
  • Kaiser Permanente Medical Center - OaklandRecruiting
  • Kaiser Permanente Medical Center - San FranciscoRecruiting
  • Synergy Dermatology
  • TrueBlue Clinical ResearchRecruiting
  • Olympian Clinical Research - TampaRecruiting
  • Atlanta Dermatology, Vein and Research Center, PCRecruiting
  • Divine Dermatology and Aesthetics, LLCRecruiting
  • NorthShore University HealthSystemRecruiting
  • DS ResearchRecruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • Dermatology and Skin Cancer Center LeawoodRecruiting
  • Industrial Medicine Associates Clinical Research Advanced Dermatology CareRecruiting
  • University of Michigan Medical CenterRecruiting
  • Oakland Hills DermatologyRecruiting
  • Somnos Clinical ResearchRecruiting
  • Skin Specialists PCRecruiting
  • Vivida DermatologyRecruiting
  • Las Vegas Clinical TrialsRecruiting
  • Schweiger Dermatology Group, PC Research DivisionRecruiting
  • Albuquerque Clinical Trials IncorporatedRecruiting
  • Chear Center LLCRecruiting
  • Accellacare of WilmingtonRecruiting
  • Bexley Dermatology ResearchRecruiting
  • Velocity Clinical Research IncRecruiting
  • Paddington Testing Company IncRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Health ConceptsRecruiting
  • US Dermatology Partners JollyvilleRecruiting
  • Newco 3A Research LLCRecruiting
  • Sante Clinical ResearchRecruiting
  • Texas Dermatology Research CenterRecruiting
  • Virginia Dermatology and Skin Cancer CenterRecruiting
  • Cinme - Centro de Investigaciones MetabolicasRecruiting
  • Framingham Centro MedicoRecruiting
  • Buenos Aires Skin S.A.Recruiting
  • Fundacion CIDEARecruiting
  • CARE- Centro de Alergia y Enfermedades RespiratoriasRecruiting
  • Psoriahue Medicina Interdisciplinaria SRLRecruiting
  • Centro de Investigaciones Clínicas del Instituto Especialidades de la Salud RosarioRecruiting
  • Emeritus Research SydneyRecruiting
  • Westmead HospitalRecruiting
  • The Skin CentreRecruiting
  • Princess Alexandra HospitalRecruiting
  • Veracity Clinical ResearchRecruiting
  • Emeritus Research MelbourneRecruiting
  • Medizinische Universitaet GrazRecruiting
  • Medizinische Universitaet InnsbruckRecruiting
  • Landeskrankenhaus SalzburgRecruiting
  • Dermatology Research Institute IncorporatedRecruiting
  • RejuvenationRecruiting
  • Alberta Derma Surgery CentreRecruiting
  • Enverus Medical ResearchRecruiting
  • Wiseman Dermatology Research Inc.Recruiting
  • SKiN HealthRecruiting
  • Centricity Research LondonRecruiting
  • Dr. S. K. Siddha Medicine Professional CorporationRecruiting
  • Allergy Research Canada IncorporatedRecruiting
  • North Bay Dermatology CentreRecruiting
  • Dermatology Ottawa Research CentreRecruiting
  • JRB Research IncorporatedRecruiting
  • The Centre for DermatologyRecruiting
  • North York Research Inc.Recruiting
  • Toronto Research Centre IncRecruiting
  • Alliance Clinical TrialsRecruiting
  • Clinique de Dermatologie RosemontRecruiting
  • Innovaderm Research IncRecruiting
  • Saskatoon Dermatology CentreRecruiting
  • DIEX Recherche QuebecRecruiting
  • Centre de Recherche Saint-LouisRecruiting
  • Nanyang First Peoples HospitalRecruiting
  • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of MedicineRecruiting
  • Peking University Peoples HospitalRecruiting
  • Hopital Prive d AntonyRecruiting
  • Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint AndréRecruiting
  • CHRU Brest Hôpital MorvanRecruiting
  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude HuriezRecruiting
  • Centre Hospitalier de Bretagne Sud - Hopital du ScorffRecruiting
  • Hôpital La TimoneRecruiting
  • Cabinet du Docteur Ruer-Mulard MireilleRecruiting
  • Centre Hospitalier Universitaire Archet 2Recruiting
  • Hopital Saint LouisRecruiting
  • Hopital Bichat Claude BernardRecruiting
  • Polyclinique de CourlancyRecruiting
  • Centre Hospitalier Universitaire de Rennes - Hopital PontchaillouRecruiting
  • Centre Hospitalier Universitaire de Rouen - Hôpital Charles NicolleRecruiting
  • CHU Saint Etienne Hopital NordRecruiting
  • Hopital d instruction des armees sainte anneRecruiting
  • Universitaetsklinikum FrankfurtRecruiting
  • Universitaetsmedizin Goettingen - Georg-August-UniversitaetRecruiting
  • TFS Trial Form Support GmbHRecruiting
  • MensingDerma research GmbHRecruiting
  • Hautaerzte Zentrum HannoverRecruiting
  • Universitaetsmedizin MainzRecruiting
  • Beldio Research GmbHRecruiting
  • Hautmedizin SaarRecruiting
  • 401 General Military Hospital Of AthensRecruiting
  • Andreas Syngros Hospital Of Venereal And Dermatological DiseasesRecruiting
  • University General Hospital of HeraklionRecruiting
  • General Hospital Of Nea Ionia Konstantopouleio PatisionRecruiting
  • Geniko Nosokomeio Peiraia TzaneioRecruiting
  • Ippokratio General Hospital of ThessalonikiRecruiting
  • Trial Pharma KftRecruiting
  • Csalogany Orvosi KozpontRecruiting
  • Clinexpert KftRecruiting
  • Obudai Egeszsegugyi Centrum KftRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Bugat Pal KorhazRecruiting
  • Somogy Varmegyei Kaposi Mor Oktato KorhazRecruiting
  • DermaMed Research KftRecruiting
  • Allergo-Derm Bakos KftRecruiting
  • Obudai Egeszsegugyi Centrum KftRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • IRCCS Istituto Clinico HumanitasRecruiting
  • Fukui Dermatology ClinicRecruiting
  • Ekihigashi Dermatology Allergy ClinicRecruiting
  • Takagi Dermatological Clinic BranchRecruiting
  • Medical Corporation Kojinkai Sapporo Skin ClinicRecruiting
  • Katahira Dermatology Urology ClinicRecruiting
  • Kosugi Dermatology ClinicRecruiting
  • Nomura Dermatology ClinicRecruiting
  • Jouzan Hihuka Hinyoukika ClinicRecruiting
  • Suizenji Dermatology ClinicRecruiting
  • Yoshioka Dermatology ClinicRecruiting
  • JA Shizuoka Kohseiren Enshu HospitalRecruiting
  • Mildix Skin ClinicRecruiting
  • Naoko Dermatology ClinicRecruiting
  • NTT Medical Center TokyoRecruiting
  • Yamate Dermatological ClinicRecruiting
  • Hospital Sultan IsmailRecruiting
  • Hospital Raja Permaisuri BainunRecruiting
  • Hospital Pulau PinangRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Hospital Kuala LumpurRecruiting
  • University Malaya Medical CentreRecruiting
  • Bravis ZiekenhuisRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Dermapolis Medical Dermatology Center dr n med Edyta GebskaRecruiting
  • GynCentrum Spzoo NZOZ Holsamed - Oddzial LiberoRecruiting
  • AppleTreeClinics Network SpzooRecruiting
  • Ip Clinic Sp zooRecruiting
  • DermMedica SpzooRecruiting
  • Doctor Samuel Sanchez PSCRecruiting
  • Theramed Healthcare SRLRecruiting
  • Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"Recruiting
  • Spitalul Clinic Judetean MuresRecruiting
  • National Skin CentreRecruiting
  • Maxderm, s.r.o.Recruiting
  • Univerzitna nemocnica Bratislava - Nemocnica Stare MestoRecruiting
  • Fakultna nemocnica s poliklinikou JA Reimana PresovRecruiting
  • Univerzitetni klinicni center LjubljanaRecruiting
  • Univerzitetni Klinicni Center MariborRecruiting
  • Hospital Clinic i Provincial de BarcelonaRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Hospital Universitario BasurtoRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Complexo Hospitalario Universitario de PontevedraRecruiting
  • Inselspital BernRecruiting
  • Hopitaux Universitaires de GeneveRecruiting
  • Centre Hospitalier Universitaire VaudoisRecruiting
  • Kantonsspital Sankt GallenRecruiting
  • Universitaetsspital ZuerichRecruiting
  • Ankara Bilkent Sehir HastanesiRecruiting
  • Istanbul Universitesi Tip FakultesiRecruiting
  • Acibadem Altunizade HastanesiRecruiting
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Dermatoloji Anabilim DaliRecruiting
  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma MerkeziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rocatinlimab Dose 1 + TCS/TCI

Rocatinlimab Dose 2 + TCS/TCI

Placebo + TCS/TCI

Arm Description

Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.

Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Outcomes

Primary Outcome Measures

Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24

Secondary Outcome Measures

Achievement of EASI 75 at Week 16
Achievement of 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 Participants 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 Participants 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 Dermatology Life Quality Index (DLQI) Score at Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response at Week 24
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants 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 ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants 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 Sleep Disturbance NRS Score at Week 24
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Achievement of a ≥ 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7

Full Information

First Posted
February 2, 2023
Last Updated
October 18, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05724199
Brief Title
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Acronym
ROCKET-SHUTTLE
Official Title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
December 12, 2024 (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 coprimary objectives of the study are to: evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

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, Eczema, Rocatinlimab, KHK4083

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rocatinlimab Dose 1 + TCS/TCI
Arm Type
Experimental
Arm Description
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
Arm Title
Rocatinlimab Dose 2 + TCS/TCI
Arm Type
Experimental
Arm Description
Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
Arm Title
Placebo + TCS/TCI
Arm Type
Placebo Comparator
Arm Description
Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Time Frame
Baseline, Week 24
Title
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Achievement of EASI 75 at Week 16
Time Frame
Baseline, Week 16
Title
Achievement of vIGA-AD 0/1 at Week 16
Time Frame
Baseline, 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 Participants 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 Participants 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 (EASI 90) at Week 24
Time Frame
Baseline, Week 24
Title
Change from Baseline in Dermatology Life Quality Index (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
Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response at Week 24
Time Frame
Baseline, Week 24
Title
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Time Frame
Baseline, Week 24
Title
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Time Frame
Baseline, Week 24
Title
Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants 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 ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4
Time Frame
Baseline, Week 24
Title
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants 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 Sleep Disturbance NRS Score at Week 24
Time Frame
Baseline, Week 24
Title
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
Time Frame
Baseline, Week 24
Title
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression 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
Change From Baseline in HADS-depression Subscale Score at Week 24
Time Frame
Baseline, Week 24
Title
Achievement of a ≥ 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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS of medium or higher potency (with or without 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 TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or 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
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Skin Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
US Dermatology Partners Sun City West
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
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
Kern Research Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck Medicine of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Wallace Medical Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
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
Kaiser Permanente South Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Name
Acclaim Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Medical Center - Oakland
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy Dermatology
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Individual Site Status
Terminated
Facility Name
TrueBlue Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympian Clinical Research - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Dermatology, Vein and Research Center, PC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Individual Site Status
Recruiting
Facility Name
Divine Dermatology and Aesthetics, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
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
Dermatology and Skin Cancer Center Leawood
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
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
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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
Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Specialists PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas Clinical Trials
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Name
Schweiger Dermatology Group, PC Research Division
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Clinical Trials Incorporated
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Chear Center LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research Inc
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
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
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
US Dermatology Partners Jollyville
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Newco 3A Research LLC
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
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
Texas Dermatology Research Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75025
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Dermatology and Skin Cancer Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Buenos Aires Skin S.A.
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1054
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion CIDEA
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1121
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CARE- Centro de Alergia y Enfermedades Respiratorias
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1414
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Psoriahue Medicina Interdisciplinaria SRL
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Clínicas del Instituto Especialidades de la Salud Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Emeritus Research Sydney
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Emeritus Research Melbourne
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Incorporated
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Rejuvenation
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
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
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
SKiN Health
City
Coburg
State/Province
Ontario
ZIP/Postal Code
K9A 4J9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 2C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr. S. K. Siddha Medicine Professional Corporation
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
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
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
JRB Research Incorporated
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
North York Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Centre Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alliance Clinical Trials
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique de Dermatologie Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1Y 3L1
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
Saskatoon Dermatology Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7T 0G3
Country
Canada
Individual Site Status
Recruiting
Facility Name
DIEX Recherche Quebec
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
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
Hopital Prive d Antony
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
Cedex
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
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Bretagne Sud - Hopital du Scorff
City
Lorient Cedex
ZIP/Postal Code
56322
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital La Timone
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Cabinet du Docteur Ruer-Mulard Mireille
City
Martigues
ZIP/Postal Code
13500
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Polyclinique de Courlancy
City
Reims
ZIP/Postal Code
51100
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
CHU Saint Etienne Hopital Nord
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital d instruction des armees sainte anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Goettingen - Georg-August-Universitaet
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Individual Site Status
Recruiting
Facility Name
MensingDerma research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hautaerzte Zentrum Hannover
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Individual Site Status
Recruiting
Facility Name
Beldio Research GmbH
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hautmedizin Saar
City
Merzing
ZIP/Postal Code
66663
Country
Germany
Individual Site Status
Recruiting
Facility Name
401 General Military Hospital Of Athens
City
Athens
ZIP/Postal Code
11525
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 Heraklion
City
Heraklion
ZIP/Postal Code
71500
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital Of Nea Ionia Konstantopouleio Patision
City
Nea Ionia
ZIP/Postal Code
14233
Country
Greece
Individual Site Status
Recruiting
Facility Name
Geniko Nosokomeio Peiraia Tzaneio
City
Piraeus
ZIP/Postal Code
18536
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
Trial Pharma Kft
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Csalogany Orvosi Kozpont
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
DermaMed Research Kft
City
Oroshaza
ZIP/Postal Code
5900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fukui Dermatology Clinic
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
454-0803
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ekihigashi Dermatology Allergy Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-0013
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
Medical Corporation Kojinkai Sapporo Skin Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
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
Kosugi Dermatology Clinic
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-0063
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
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
JA Shizuoka Kohseiren Enshu Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mildix Skin Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Naoko Dermatology Clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
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
Yamate Dermatological Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0075
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Georgetown
State/Province
Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth Hospital
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Bravis Ziekenhuis
City
Bergen op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
City
Katowice
ZIP/Postal Code
40-600
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
Ip Clinic Sp zoo
City
Lodz
ZIP/Postal Code
90-752
Country
Poland
Individual Site Status
Recruiting
Facility Name
DermMedica Spzoo
City
Wroclaw
ZIP/Postal Code
51-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Doctor Samuel Sanchez PSC
City
Caguas
ZIP/Postal Code
00727-9507
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Theramed Healthcare SRL
City
Brasov
ZIP/Postal Code
500112
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
Spitalul Clinic Judetean Mures
City
Targu Mures
ZIP/Postal Code
540613
Country
Romania
Individual Site Status
Recruiting
Facility Name
National Skin Centre
City
Singapore
ZIP/Postal Code
308205
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Maxderm, s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica s poliklinikou JA Reimana Presov
City
Presov
ZIP/Postal Code
081 81
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitetni klinicni center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Univerzitetni Klinicni Center Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Basurto
City
Bilbao
State/Province
País Vasco
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hopitaux Universitaires de Geneve
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Sankt Gallen
City
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Zuerich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Acibadem Altunizade Hastanesi
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
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 Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

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