A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Atopic DermatitisThe primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
12 and up
Participation 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 28 days.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
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.
Study Location
Stratica Dermatology
Stratica DermatologyEdmonton, Alberta
Canada
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Interior Dermatology Centre
Interior Dermatology CentreKelowna, British Columbia
Canada
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Wiseman Dermatology Research Incorporated
Wiseman Dermatology Research IncorporatedWinnipeg, Manitoba
Canada
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SKiN Health
SKiN HealthCoburg, Ontario
Canada
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Triple A Lab
Triple A LabHamilton, Ontario
Canada
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Dr SK Siddha Medicine Professional Corporation
Dr SK Siddha Medicine Professional CorporationNewmarket, Ontario
Canada
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The Centre for Clinical Trials Inc
The Centre for Clinical Trials IncOakville, Ontario
Canada
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The Centre for Dermatology
The Centre for DermatologyRichmond Hill, Ontario
Canada
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Toronto Research Centre Inc
Toronto Research Centre IncToronto, Ontario
Canada
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Alliance Clinical Trials
Alliance Clinical TrialsWaterloo, Ontario
Canada
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Clinique Medicale Saint Louis
Clinique Medicale Saint LouisQuebec City, Quebec
Canada
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Laser Rejuvenation Clinics Edmonton D T Incorporated
Laser Rejuvenation Clinics Edmonton D T IncorporatedEdmonton, Alberta
Canada
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Skin Physicians Dermatology
Skin Physicians DermatologyEdmonton, Alberta
Canada
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Winnipeg Clinic Dermatology Research
Winnipeg Clinic Dermatology ResearchWinnipeg, Manitoba
Canada
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SimcoDerm Medical and Surgical Dermatology Centre
SimcoDerm Medical and Surgical Dermatology CentreBarrie, Ontario
Canada
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LEADER Research
LEADER ResearchHamilton, Ontario
Canada
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DermEdge Research Incorporated
DermEdge Research IncorporatedMississauga, Ontario
Canada
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Canadian Dermatology Centre
Canadian Dermatology CentreNorth York, Ontario
Canada
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SKiN Centre for Dermatology
SKiN Centre for DermatologyPeterborough, Ontario
Canada
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North York Research Incorporated
North York Research IncorporatedToronto, Ontario
Canada
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Evidence Based Medical Educator Inc
Evidence Based Medical Educator IncToronto, Ontario
Canada
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Innovaderm Research Inc
Innovaderm Research IncMontreal, Quebec
Canada
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Dermatology Research Institute Incorporated
Dermatology Research Institute IncorporatedCalgary, Alberta
Canada
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Alberta Derma Surgery Centre
Alberta Derma Surgery CentreEdmonton, Alberta
Canada
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Doctor Chih-Ho Hong Medical Incorporated
Doctor Chih-Ho Hong Medical IncorporatedSurrey, British Columbia
Canada
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Karma Clinical Trials
Karma Clinical TrialsSaint John's, Newfoundland and Labrador
Canada
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Kingsway Clinical Research
Kingsway Clinical ResearchEtobicoke, Ontario
Canada
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Centricity Research London Victoria
Centricity Research London VictoriaLondon, Ontario
Canada
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Allergy Research Canada Incorporated
Allergy Research Canada IncorporatedNiagara Falls, Ontario
Canada
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JRB Research Incorporated
JRB Research IncorporatedOttawa, Ontario
Canada
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York Dermatology Clinic and Research Centre
York Dermatology Clinic and Research CentreRichmond Hill, Ontario
Canada
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FACET Dermatology
FACET DermatologyToronto, Ontario
Canada
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XLR8 Medical Research, Incorporated
XLR8 Medical Research, IncorporatedWindsor, Ontario
Canada
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Skinsense Medical Research
Skinsense Medical ResearchSaskatoon, Saskatchewan
Canada
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Beacon Dermatology
Beacon DermatologyCalgary, Alberta
Canada
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Vida Clinical Research
Vida Clinical ResearchEdmonton, Alberta
Canada
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Enverus Medical Research
Enverus Medical ResearchSurrey, British Columbia
Canada
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CCA Medical Research Corp
CCA Medical Research CorpAjax, Ontario
Canada
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Guelph Dermatology Research
Guelph Dermatology ResearchGuelph, Ontario
Canada
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Lynderm Research Inc
Lynderm Research IncMarkham, Ontario
Canada
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Dermatology Ottawa Research Centre
Dermatology Ottawa Research CentreOttawa, Ontario
Canada
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North Bay Dermatology Centre
North Bay Dermatology CentreNorth Bay, Ontario
Canada
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Oak Ridges Aesthetics Centre
Oak Ridges Aesthetics CentreRichmond Hill, Ontario
Canada
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Research Toronto
Research TorontoToronto, Ontario
Canada
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Clinique de Dermatologie Rosemont
Clinique de Dermatologie RosemontMontreal, Quebec
Canada
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Saskatoon Dermatology Centre
Saskatoon Dermatology CentreSaskatoon, Saskatchewan
Canada
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- Study Sponsored By
- Amgen
- Participants Required
- More Information
- Study ID:
NCT05882877