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Clinical trialNCT04408625Active, not recruitingPhase 1/PHASE2Interventional

Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

SponsorPrevail TherapeuticsEnrollment35Frontotemporal Dementia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Prince Alfred Hospital, Brain & Mind Research Institute, 94 Mallet Street

    Camperdown, New South Wales, Australia

Belgium
  • Uz Leuven, Neurologie Herestraat 49

    Leuven, Belgium

France
  • Ap-Hm Hôpital de la Timone

    Saint-Pierre, Marseille, France

  • Centre Mémoire de Ressources

    Lille, France

  • Le Ber, Institut Du Cerveau Et de la Moelle Epinière

    Paris, France

Spain
  • Hospital Clinic de Barcelona, Villaroel 170 Servicio de Neurología

    Barcelona, Spain

  • Hospital Universitario de Donostia, Servicio de Neurologia, Consultas Externas Neurologia, San Sebastian, Guipúzcoa

    Donostia / San Sebastian, Spain

United Kingdom
  • University College London,queen Square, Dementia Research Building, London,

    London, United Kingdom

United States
  • K2 Medical Research-Maitland

    Maitland, Florida, United States

  • Ppd Phase 1 Clinic, 100 West Gore Street, Suite 202

    Orlando, Florida, United States

  • Lahey Hospital & Medical Center, 41 Burlington Mall Road

    Burlington, Massachusetts, United States

  • Hospital of the University of Pennsylvania, 3 West Gates Building, 3400 Spruce Street

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

LY3884963Methylprednisolone →Optional PrednisoneOptional Sirolimus
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Nov 2020
Primary completion
30 Nov 2029
Completion
30 Nov 2029
Last update posted
16 Jul 2026
Registered enrollment
35
Registry id
NCT04408625
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.