A Phase 1/2 interventional study of veltuzumab in Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Autoimmune, sponsored by Gilead Sciences. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Gilead Sciences · Phase 1/2, Interventional, and Treatment
This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
The goal of current treatment guidelines for most patients with chronic adult ITP is to maintain platelet levels above 30 x 109/L. The conventional first-line therapy is corticosteroids with or without intravenous immunoglobulins, but many patients relapse when steroids are tapered. Standard therapy then is splenectomy, but patients with refractory ITP who do not respond require further therapy. Unfortunately, immunosuppressive agents or other available treatments typically produce only short-term responses. Because of the lack of medical options after first-line therapy, the target population for this first study of anti-CD20 immunotherapy with hA20 are adult patients with chronic ITP who failed at least one standard ITP therapy (i.e., received at least one standard ITP therapy and now present with platelet levels below 30 x 109/L).
In autoimmune disease, rituximab as well as other anti-CD20 antibodies currently being considered for commercialization have focused on a different dosing schedule in rheumatoid arthritis, and use fixed dosages rather than variable doses based on body surface area. In addition, recent studies of these newer anti-CD20 antibodies in rheumatoid arthritis have reported that lower doses indeed appear effective when administered twice, 2 weeks apart. Based upon these considerations, patients in this study will receive hA20 twice, 2 weeks apart, and administered at one of 3 dose levels.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
See full protocol for exclusion criteria or contact study staff for details
veltuzumab is a humanized CD20 antibody administered subcutaneously.
Biological: veltuzumab
hA20 will be administered intravenously in two doses over two weeks
Also known as: IMMU-106, hA20, humanized anti-CD20
Primary - Safety
Hematology laboratory results and adverse events will be followed closely for one year.
Time frame: 1 year
Secondary - Efficacy
Platelet responses will be followed for up to 5 years.
Time frame: 5 years
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gilead Sciences