A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 17, 2025

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
• • Satisfy all ISA specific inclusion criteria
• • Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
• • Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA
• Exclusion Criteria:
• • Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
• • Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
• • Meets any exclusion criteria within the pertinent ISA