A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Official record

Identifier

NCT06788509

Recruiting locations

countries

AustraliaBelgiumFranceGeorgiaGreeceIsraelJapanMoldovaPolandSouth KoreaSpainTaiwanUkraineUnited Kingdom

Interventions studied

JNJ-75348780JNJ-67856633JNJ-54179060JNJ-64264681JNJ-74856665JNJ-70218902JNJ-64619178JNJ-80948543JNJ-87801493

Lead sponsor

Janssen Research & Development, LLC

Target enrolment

120 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Enrolling by invitation

First posted

Jan 23, 2025

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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