INCA000585-201_Phase 2a Study of Tafasitamab in Adults with Autoimmune Blood Cell Disorders
Research type
Research Study
Full title
A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
IRAS ID
1012879
Contact name
Aaron Packman
Contact email
Sponsor organisation
Incyte Corporation
Research summary
This Study is being done to find out if tafasitamab is safe and how it works in people with long lasting ITP or wAIHA who have had prior treatment. The Study participation will last for approximately 52 weeks. This includes the 28-day screening period, 8 visits for infusion of the study drug tafasitamab treatment, and 40 weeks of less frequent visits, a total of 21 visits to the Study Site. Some visit days will be longer than others depending on what is happening at that visit. After signing the Participant Information Sheet and Informed Consent Form, participants will have tests and procedures, so the Study Doctor can confirm eligibility to participate. Many of these tests and procedures are likely to be part of regular care and may be done even if it turns out that they don't take part in the Study. Tests or procedures recently performed, may not have to be repeated.
Treatment starts after the Study Doctor reviews the results of tests and procedures to confirms participants qualify. Participants will receive the tafasitamb treatment and have visits to the Study Site. The list of tests and procedures to be performed in each visit is part of the PIS.
You will have an end-of-treatment visit after you take your last dose.
Follow-up happens every 4 weeks after you have completed the treatment phase.
In Follow up participants will have a visit at the study site or at-home nursing visits, so the Study Doctor can check their health and for any side effects. To reduce the burden of frequent on-site visits, at-home blood collection may be conducted via home nursing for non-clinic (Laboratory only) visits. After 52 weeks the participation ends.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0294
Date of REC Opinion
10 Nov 2025
REC opinion
Further Information Favourable Opinion