Purpose of this Study
We are doing this study to find out if an experimental drug called mezagitamab (the study drug) is a safe and effective option for people with chronic primary immune thrombocytopenia (ITP). We want to know if adding the study drug to someone's current treatment has any benefit.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with chronic primary immune thrombocytopenia
- Were diagnosed at least 12 months ago
- Have evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for ITP
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to either take the study drug or a placebo (inactive substance with no drug in it). You will have a 2-in-3 chance of getting the study drug. Both the study drug and placebo are given as a subcutaneous injection (shots under the skin).
You will get a dose of the study drug and placebo once per week for 2 8-week periods of time. Between these two dosing periods, you will take an 8-week break and not get any doses of the study drug/placebo.
At the end of the study, you may have the option to continue participating in an extension study.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia
Principal Investigator
Ara
Metjian
Protocol Number
PRO00116960
NCT ID
NCT06722235
Phase
III
Enrollment Status
Pending Open to Enrollment