Lya Provider Hub

CT-LYA-244 Trial Detail

LYA-Immuno 2 | Phase 4 | Active, not recruiting

Protocol: LYA-244-P4

NCT: NCT05741092

Enrollment: 978/1200

Protocol and Endpoints

Evidence and design details for provider screening conversations.

Sponsor

Lya Immunology Medical Affairs

Adults with moderate to severe autoimmune disease receiving routine practice treatment.

Primary: 24-month persistence rate

Secondary: Serious infection incidence

Exploratory: Patient-reported disease control and productivity

Safety and Contact Pathways

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

Quarterly safety review board oversight

Treatment interruption criteria standardized across sites

Registry Onboarding

Owner: RWE Operations

Channel: portal request

Safety Escalation

Owner: Drug safety team

Channel: 24/7 hotline

Data Quality

Owner: Outcomes analytics

Channel: ticket

Inclusion Highlights

Quick pre-screen items before referral.

Adult diagnosis confirmed by specialist

Initiating or continuing LYA-Immuno 2 per label

Ability to complete digital follow-up surveys

Exclusion Highlights

Common reasons candidates are ruled out.

Concurrent participation in interventional biologic trial

Active severe infection at enrollment

Referral Workflow

Provider-to-site handoff sequence.

Step 1

Provider identifies eligible ongoing-care patients

Step 2

Coordinator sends digital consent workflow

Step 3

Registry team validates data completeness

Visit Timeline

Operational schedule used by coordinators and referring sites.

Enrollment (Day 0)

Consent, baseline disease activity

Routine follow-up (Every 8 weeks)

Persistence and safety collection

Long-term (Up to month 24)

Outcome trend and therapy continuity

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.