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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509441-13-00

Acronym

ACT17209

Enrollment

Registered

2024-02-27

Start date

2022-01-31

Completion date

Unknown

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Warm autoimmune hemolytic anemia

Brief summary

Proportion of participants with overall hemoglobin response, Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response

Detailed description

Proportion of participants with durable hemoglobin response, Median time from baseline to first hemoglobin response, Frequency of rescue therapy (any wAIHA-directed therapy other than predniso[lo]ne or transfusion) received, Change from baseline in FACIT-Fatigue scale score, Safety assessments

Interventions

DRUGRilzabrutinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants with overall hemoglobin response, Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response	—

Secondary

Measure	Time frame
Proportion of participants with durable hemoglobin response, Median time from baseline to first hemoglobin response, Frequency of rescue therapy (any wAIHA-directed therapy other than predniso[lo]ne or transfusion) received, Change from baseline in FACIT-Fatigue scale score, Safety assessments	—

Countries

Denmark, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026