NCT05002777

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (LUMINA 2)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A. Participants who complete Part A and are deemed eligible for Part B can continue in the Core Part B period followed by an Extended Part B period for up to 253 weeks. There will be a 7-day safety follow-up period after receiving the last dose of study medication either in Part A (for those not eligible for Part B or early terminated) or Part B. In addition, each participant will be asked to attend an EOT-Core Part B visit when the last participant completes 52 weeks in Core Part B. The Extended Part B period will last for up to 253 weeks.

Conditions

• Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions

Type	Name	Description
DRUG	rilzabrutinib	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2021-12-07
• Primary completion: 2024-05-23
• Completion: 2029-12-31
• First posted: 2021-08-12
• Last updated: 2025-05-21

Locations

27 sites across 9 countries: United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study