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Monoclonal Antibodies

LY3884961 for Gaucher Disease

Hospital Universitario Ramon y Cajal, Calle Colmenar Viejo Km 9100, Madrid, Spain

Targeting 2 different conditionsLY3884961Phase 1 & 2RecruitingResearch Sponsored by Prevail Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of suboptimal response to ERT or SRT.

Age 18-65 years inclusive at the time of informed consent.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up5 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is a Phase 1/2, multicenter, open-label study of LY3884961, which is being evaluated for safety and tolerability in adults with peripheral manifestations of GD. Up to 3 dose levels of LY3884961 will be assessed in 3 dose-finding cohorts of 3 patients, and then up to 6 patients may be enrolled into an expansion cohort. For each enrolled patient, the study will last approximately 5 years, including up to a 45-day screening period. During the first 18 months after dosing, subjects will be evaluated for the effects of LY3884961 on safety, tolerability, immun

Eligible Conditions

Gaucher Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You did not respond well to enzyme replacement therapy (ERT) or substrate reduction therapy (SRT).

Select...

You are between 18 and 65 years old when you agree to take part in the study.

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Your bi-allelic GBA1 mutations need to be confirmed by a central authority.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Discontinuation of enzyme replacement therapy (ERT)/substrate reduction therapy (SRT)

GCase levels in blood

GluSph levels in blood

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LY3884961Experimental Treatment1 Intervention

LY3884961 is an advanced therapy investigational medicinal product administered as a single intravenous infusion.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prevail TherapeuticsLead Sponsor

3 Previous Clinical Trials

58 Total Patients Enrolled

1 Trials studying Gaucher Disease

15 Patients Enrolled for Gaucher Disease

Eli Lilly and CompanyIndustry Sponsor

2,565 Previous Clinical Trials

3,181,000 Total Patients Enrolled

1 Trials studying Gaucher Disease

15 Patients Enrolled for Gaucher Disease

Sarah Neuhaus, DOStudy DirectorPrevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Media Library

Gaucher Disease Clinical Trial 2023: LY3884961 Highlights & Side Effects. Trial Name: NCT05487599 — Phase 1 & 2

LY3884961 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487599 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is an individual such as myself eligible for participation in this trial?

"To be eligible for the clinical trial, applicants must have Gaucher Disease and between 18-50 years of age. There is capacity to include around 15 patients in the study."

Answered by AI

Is registration for this experiment currently taking place?

"According to the clinicaltrials.gov page, this trial is not actively looking for participants at the moment, despite originally being posted on August 1st 2022 and lastly updated a month later. However, there are 15 other studies that are currently open for recruitment."

Answered by AI