Lya Provider Hub

CT-LYA-178 Trial Detail

LYA-Neuro 3 | Phase 3 | Primary completion met

Protocol: LYA-178-P3

NCT: NCT05699874

Enrollment: 520/520

Protocol and Endpoints

Evidence and design details for provider screening conversations.

Sponsor

Lya Neuroscience Development

Adults with relapsing neurologic disease and recent clinical or MRI activity.

Primary: Annualized relapse rate

Secondary: MRI lesion burden change

Secondary: Confirmed disability progression

Safety and Contact Pathways

How provider teams route scientific, safety, and site feasibility questions.

Infusion observation protocol required for first two doses

Pre-dose lab and neurologic screening at each visit

Protocol Clarifications

Owner: Medical Science Liaison

Channel: MSL request

Enrollment Support

Owner: Site activation lead

Channel: secure email

Data Capture

Owner: Clinical data manager

Channel: portal task

Inclusion Highlights

Quick pre-screen items before referral.

Relapse within prior 12 months or MRI activity

Neurology specialist oversight

Baseline functional score documented

Exclusion Highlights

Common reasons candidates are ruled out.

Progressive-only phenotype

Recent investigational exposure within washout

Contraindicated comorbidity profile

Referral Workflow

Provider-to-site handoff sequence.

Step 1

Provider flags candidate from relapse review

Step 2

Research nurse confirms key criteria

Step 3

Neurology PI performs final sign-off

Visit Timeline

Operational schedule used by coordinators and referring sites.

Screening (Day -30 to -1)

Eligibility, MRI, baseline function

Dosing (Protocol schedule)

Infusion and monitoring

Closeout (Month 12)

Endpoint capture and extension decision

Capture Trial Coordination Info

Add real referral and screening data from your site.

Add Trial Candidate

Track referral-ready candidates and next screening step.

Add Site Feasibility Note

Document site capacity, start-up blockers, or activation needs.