Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05073458
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary warm AIHA.
* Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to receive or tolerate other therapies.
* Hemoglobin ≥ 6.5 to \< 10 g/dL with symptoms of anemia at screening.
* FACIT-F score ≤ 43 at screening.
* Willingness to avoid pregnancy or fathering children.
* Willingness to receive PJP prophylaxis.
* Further inclusion criteria apply.
Exclusion Criteria:
* Women who are pregnant, breastfeeding or who are planning a pregnancy.
* Diagnosis of other types of AIHA (CAD, cold agglutinin syndrome, mixed-type AIHA or paroxysmal cold hemoglobinuria).
* Secondary warm AIHA from any cause or diagnosis of Evans syndrome.
* Splenectomy less than 3 months before randomization.
* Participants with a history or ongoing significant illness as assessed by the investigator.
* Participants with a current of medical history of a malignancy within the past 5 years except basal or squamous cell skin cancer that has been removed and considered cured, or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
* Participants know to be infected with HIV, Hepatitis B, or hepatitis C.
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine.
* Participants with laboratory values outside of the protocol defined ranges.
* Further exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05073458
Study Brief:
Protocol Section:
NCT05073458