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A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

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, Rocatinlimab, AMG 451, Eczema

Eligibility Criteria

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

Inclusion Criteria: Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 14 days. Exclusion Criteria: Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

Sites / Locations

  • Cahaba Dermatology and Skin Health CenterRecruiting
  • Medical Dermatology SpecialistsRecruiting
  • Alliance Dermatology and Mohs CenterRecruiting
  • Arkansas Research Trials, LLCRecruiting
  • Kern Research IncRecruiting
  • West Coast Research LLCRecruiting
  • California Dermatology and Clinical Research InstituteRecruiting
  • Antelope Valley Clinical TrialsRecruiting
  • Long Beach Research Institute, LLCRecruiting
  • Dermatology Research AssociatesRecruiting
  • University of California at Davis Medical CenterRecruiting
  • Saint Jude Clinical ResearchRecruiting
  • Direct Helpers Research CenterRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • The Indiana Clinical Trials Center PCRecruiting
  • Options Research Group LLCRecruiting
  • Dermatology and Skin Cancer Center LeawoodRecruiting
  • Kentucky Advanced Medical Research LLCRecruiting
  • Revival Research Institute LLCRecruiting
  • Jubilee Clinical Research IncRecruiting
  • Skin Cancer and Dermatology InstituteRecruiting
  • Wilmington Dermatology CenterRecruiting
  • Bexley Dermatology ResearchRecruiting
  • Essential Medical Research, LLCRecruiting
  • Velocity Clinical Research IncRecruiting
  • Paddington Testing Company IncRecruiting
  • DermDox Dermatology, LLCRecruiting
  • Cumberland Skin CenterRecruiting
  • Newco 3A Research LLCRecruiting
  • Texas Dermatology Research CenterRecruiting
  • Texas Dermatology and Laser SpecialistsRecruiting
  • The Alfred HospitalRecruiting
  • Doctor Chih-Ho Hong Medical IncorporatedRecruiting
  • Enverus Medical ResearchRecruiting
  • Wiseman Dermatology Research Inc.Recruiting
  • CCA Medical Research CorporationRecruiting
  • SimcoDerm Medical and Surgical Dermatology CentreRecruiting
  • LEADER researchRecruiting
  • DermEdge Research IncorporatedRecruiting
  • Dr. S. K. Siddha Medicine Professional CorporationRecruiting
  • Allergy Research Canada IncorporatedRecruiting
  • North Bay Dermatology CentreRecruiting
  • The Centre for Clinical Trials IncRecruiting
  • The Centre for DermatologyRecruiting
  • Alliance Clinical TrialsRecruiting
  • XLR8 Medical Research, IncorporatedRecruiting
  • Innovaderm Research IncRecruiting
  • Miyata Dermatology ClinicRecruiting
  • International University of Health and Welfare Narita HospitalRecruiting
  • Matsuo ClinicRecruiting
  • Asahikawa City HospitalRecruiting
  • Kaji Dermatology ClinicRecruiting
  • Suizenji Dermatology ClinicRecruiting
  • Rakuwakai Otowa HospitalRecruiting
  • Osaka Habikino Medical CenterRecruiting
  • Dermatology and Ophthalmology Kume ClinicRecruiting
  • JA Shizuoka Kohseiren Enshu HospitalRecruiting
  • Mita Dermatology ClinicRecruiting
  • NTT Medical Center TokyoRecruiting
  • Shirasaki Dermatology ClinicRecruiting
  • Korea University Ansan HospitalRecruiting
  • The Catholic University of Korea Incheon St Marys HospitalRecruiting
  • Inha University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • The Catholic University of Korea Seoul St Marys HospitalRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

ARM A: Dose 1 to Dose 1

ARM B: Dose 2 to Dose 2

ARM C: Dose 1 or Dose 2 to Placebo

ARM D: Placebo to Placebo

ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1

Arm Description

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W).

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.

Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, or ROCKET-SHUTTLE who received placebo will be randomized to receive placebo Q4W.

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET-ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab studies ROCKET-VOYAGER or ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events

Secondary Outcome Measures

Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1 Response Among Participants Achieving vIGA-AD 0/1 Response at Day 1
Maintaining vIGA-AD 0/1 and Presence of Barely Perceptible Erythema or No Erythema Response Among Participants Achieving vIGA-AD 0/1 With Additional Assessments of Morphology Response at Day 1
Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1
Maintaining vIGA-AD 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD 0/1 Response and EASI 75 Response at Day 1
Percent Change From Parent Study Baseline in EASI Score Among Participants Achieving EASI 75 Response at Day 1
Maintaining ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus Numerical Rating Scale (NRS) Score
Among Participants Achieving ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Day 1

Full Information

First Posted
May 22, 2023
Last Updated
October 9, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05882877
Brief Title
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Acronym
ROCKET-ASCEND
Official Title
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
March 5, 2027 (Anticipated)
Study Completion Date
March 5, 2027 (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 primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A: Dose 1 to Dose 1
Arm Type
Experimental
Arm Description
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W).
Arm Title
ARM B: Dose 2 to Dose 2
Arm Type
Experimental
Arm Description
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.
Arm Title
ARM C: Dose 1 or Dose 2 to Placebo
Arm Type
Placebo Comparator
Arm Description
Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.
Arm Title
ARM D: Placebo to Placebo
Arm Type
Placebo Comparator
Arm Description
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, or ROCKET-SHUTTLE who received placebo will be randomized to receive placebo Q4W.
Arm Title
ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1
Arm Type
Experimental
Arm Description
Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET-ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab studies ROCKET-VOYAGER or ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451, KHK4083
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events
Time Frame
Up to 116 weeks
Secondary Outcome Measure Information:
Title
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1 Response Among Participants Achieving vIGA-AD 0/1 Response at Day 1
Time Frame
Up to 104 weeks
Title
Maintaining vIGA-AD 0/1 and Presence of Barely Perceptible Erythema or No Erythema Response Among Participants Achieving vIGA-AD 0/1 With Additional Assessments of Morphology Response at Day 1
Time Frame
Up to 104 weeks
Title
Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1
Time Frame
Up to 104 weeks
Title
Maintaining vIGA-AD 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD 0/1 Response and EASI 75 Response at Day 1
Time Frame
Up to 104 weeks
Title
Percent Change From Parent Study Baseline in EASI Score Among Participants Achieving EASI 75 Response at Day 1
Time Frame
Up to 104 weeks
Title
Maintaining ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus Numerical Rating Scale (NRS) Score
Description
Among Participants Achieving ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Day 1
Time Frame
Up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 14 days. Exclusion Criteria: Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology and Skin Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Dermatology and Mohs Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
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
West Coast Research LLC
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Individual Site Status
Recruiting
Facility Name
California Dermatology and Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Research Institute, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
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
Saint Jude Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
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
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
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
Options Research Group LLC
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
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
Kentucky Advanced Medical Research LLC
City
Murray
State/Province
Kentucky
ZIP/Postal Code
42071
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Jubilee Clinical Research Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Cancer and Dermatology Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Individual Site Status
Recruiting
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
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 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
DermDox Dermatology, LLC
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Skin Center
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Name
Newco 3A Research LLC
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
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
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Doctor Chih-Ho Hong Medical Incorporated
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
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
CCA Medical Research Corporation
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Individual Site Status
Recruiting
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEADER research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
DermEdge Research Incorporated
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
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
The Centre for Clinical Trials Inc
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
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
Alliance Clinical Trials
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
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
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
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
International University of Health and Welfare Narita Hospital
City
Narita-shi
State/Province
Chiba
ZIP/Postal Code
286-8520
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
Kaji Dermatology Clinic
City
Nonoichi-shi
State/Province
Ishikawa
ZIP/Postal Code
921-8801
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
Rakuwakai Otowa Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Habikino Medical Center
City
Habikino-shi
State/Province
Osaka
ZIP/Postal Code
583-8588
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
JA Shizuoka Kohseiren Enshu Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mita Dermatology Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
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
Shirasaki Dermatology Clinic
City
Takaoka-shi
State/Province
Toyama
ZIP/Postal Code
933-0871
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
The Catholic University of Korea Incheon St Marys Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
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
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
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
Ajou University Hospital
City
Suwon-si, Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
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 Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

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