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

Study acronym: PROCLAIM
StatusActive, Not Recruiting
PhasePhase 1/2
Started2020-11-09
View 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.

Amendment record

Amended 19 times since 2020-05-28; most recent filed 2026-07-14. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-07-14
Amendment Study Status v19
2026-04-28
Amendment Study Status v18
2026-02-05
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v17
2025-12-08
Amendment Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
2025-03-14
Amendment Study Status, Contacts/Locations v15
2024-12-05
Amendment Study Status v14
2024-10-17
Amendment Study Status, Contacts/Locations v13
2024-07-18
Amendment Study Status, Study Design, Contacts/Locations v12
2024-05-22
Amendment Study Status, Contacts/Locations, References v11
2024-01-15
Amendment Study Status, Contacts/Locations v10
2023-11-07
Amendment Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
2023-09-15
Amendment Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v8
2023-04-05
Amendment Study Status, Contacts/Locations v7
2022-07-01
Amendment Study Status, Eligibility, Contacts/Locations v6
2022-03-02
Amendment Study Status, Contacts/Locations v5
2021-08-18
Amendment Study Status, Contacts/Locations v4
2021-05-13
Amendment Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
2020-09-01
Amendment Study Status v2
2020-08-27
Amendment Not Yet Recruiting→Recruiting Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
2020-05-28
Original filing
Trial Details
NCT Number NCT04408625
Lead Sponsor Prevail Therapeutics
Collaborators: Eli Lilly and Company
Conditions Frontotemporal Dementia
Enrollment 35 participants
Start Date 2020-11-09
Primary Completion 2029-11-30 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16