Recruiting NCT06722235

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Phase III Interventional Immune Thrombocytopenic Purpura (ITP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Mezagitamab, Placebo.
Who it may be relevant to: Registry conditions: Immune Thrombocytopenic Purpura (ITP). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Bulgaria, China, Croatia +13
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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).

Interventions

Drug Mezagitamab
Mezagitamab injection administered SC.
Drug Placebo
Mezagitamab-matching placebo injection administered SC.

Primary outcome measures

Percentage of Participants With Durable Platelet Response [Time frame: Up to Week 24]

Secondary outcome measures (12)

Cumulative Number of Weeks With a Platelet Count of ≥50,000/μL [Time frame: Up to Week 24]
Time to First Platelet Count ≥50,000/μL [Time frame: Up to Week 24]
Cumulative Number of Weeks With a Platelet Count of ≥30,000/μL [Time frame: Up to Week 24]
Percentage of Participants With Complete Platelet Response [Time frame: Up to Week 24]
Percentage of Participants With Platelet Response at Week 16 [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 [Time frame: Weeks 16 and 24]
Change from Baseline in Physical Fatigue (Item 10) Score of the ITP-PAQ at Weeks 16 and 24 [Time frame: Weeks 16 and 24]
Percentage of Participants Receiving Rescue Therapy [Time frame: Up to Week 24]
Percentage of Participants With Bleeding Events [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]

Eligibility criteria

Inclusion criteria

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.
If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.

Exclusion criteria

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).
History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies:

The last dose was received within 6 months before screening.
The last dose was received between 6 and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.
The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.
The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.
The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation.

Other protocol defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 25 centers

Genesis Cancer and Blood Institute - SCRI — Hot Springs
USC Norris Comprehensive Cancer Center - Keck Medicine of USC — Los Angeles
University of California San Diego Center for Bleeding and Clotting Disorders — San Diego
Rocky Mountain Cancer Center — Denver
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center — Washington D.C.
Emory University — Atlanta
Innovative Hematology, Inc. — Indianapolis
The University of Iowa — Iowa City
… and 17 more centers

China · 16 centers

Peking Union Medical College Hospital — Beijing
Guangdong Provincial People's Hospital — Guangzhou
The First Affiliated Hospital of Guangxi Medical University — Nanning
The First Hospital of Hebei Medical University — Shijiazhuang
Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
Henan Cancer Hospital — Zhengzhou
The First Affiliated Hospital of Soochow University - Shizijie Campus — Suzhou
The First Affiliated Hospital of Nanchang University - Donghu Campus — Nanchang
… and 8 more centers

Japan · 13 centers

Chiba Aoba Municipal Hospital — Chuo-ku
Chibaken Saiseikai Narashino Hospital — Narashino-shi
National Hospital Organization Mito Medical Center — Ibaraki
Yokohama City University Medical Center — Yokohama
Tohoku University Hospital — Sendai
Kansai Medical University Hospital — Hirakata-shi
Hematology Ohta Clinic,Shinsaibashi — Osaka
… and 6 more centers

Italy · 11 centers

Azienda Ospedaliera Universitaria Federico II — Naples
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma — Rome
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi — Catania
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda — Milan
Fondazione IRCCS San Gerardo Dei Tintori — Monza
A.O.U. Maggiore della Carita — Novara
Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome
… and 3 more centers

Australia · 10 centers

Canberra Hospital — Garran
Concord Repatriation General Hospital — Concord
St George Hospital — Kogarah
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centr — Liverpool
Westmead Hospital — Westmead
Peter MacCallum Cancer Centre — Melbourne
Monash University - Australian Centre for Blood Diseases (ACBD) — Melbourne
The Alfred Hospital — Melbourne
… and 2 more centers

United Kingdom · 10 centers