A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant has been diagnosed with ITP that has persisted for at least 12 months.
The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count ≥50,000/μL.
The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
The participant has a mean platelet count of less than (<)30,000/μL.
Disqualifiers
The participant has secondary ITP.
The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
The participant has had a splenectomy.
The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Trial design
Design model
Parallel
Treatments tested in this trial
Mezagitamab
DrugMezagitamab injection administered SC.
Placebo
DrugMezagitamab-matching placebo injection administered SC.
Treatment groups
171 Participants
are divided into 2 treatment groupsGroup A: MezagitamabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Durable Platelet Response
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
Time frame
Up to Week 24Secondary outcomes
1
Cumulative Number of Weeks With a Platelet Count of ≥50,000/μL
The cumulative number of weeks in which the platelet count is ≥50,000/μL through Week 24.
Time frame
Up to Week 242
Time to First Platelet Count ≥50,000/μL
Time frame
Up to Week 243
Cumulative Number of Weeks With a Platelet Count of ≥30,000/μL
The cumulative number of weeks in which the platelet count is ≥30,000/μL, and at least doubled from baseline through Week 24.
Time frame
Up to Week 244
Percentage of Participants With Complete Platelet Response
Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits through Week 24.
Time frame
Up to Week 24 Source ClinicalTrials.gov