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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
171
Mezagitamab injection administered SC.
Mezagitamab placebo-matching injection administered SC.
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, United States
RECRUITINGRocky Mountain Cancer Center
Denver, Colorado, United States
WITHDRAWNGeorgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
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 24
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 24
Time to First Platelet Count ≥50,000/μL
Time frame: Up to Week 24
The 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 24
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
Percentage of Participants with Platelet Response at Week 16
Platelet response is defined as a platelet count ≥50,000/μL before investigational medicinal product (IMP) administration at the Week 16 visit.
Time frame: Week 16
Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24
ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. The 6-item symptoms domain is scored from 0 to 100, with higher scores representing improvement of symptoms.
Time frame: Weeks 16 and 24
Percentage of Participants Receiving Rescue Therapy
Time frame: Up to Week 24
Percentage of Participants with Bleeding Events
Bleeding events are defined as Grade ≥2 in the skin domain, or Grade ≥1 in the mucosal domain, or Grade ≥1 in the organ domain, in the immune thrombocytopenia-specific bleeding assessment tool (ITP-BAT) through Week 24.
Time frame: Up to Week 24
Serum Concentration of Mezagitamab During and After Intervention
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
Number of Participants with Anti-drug Antibodies (ADA)
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
Change in ADA Titers Over Time
Time frame: Up to Day 169
Number of Participants with Neutralizing ADA
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 169
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Iowa
Iowa City, Iowa, United States
RECRUITINGUniversity Of Louisville Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGAmerican Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITING...and 102 more locations