A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Conditions

• Immune Thrombocytopenic Purpura (ITP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mezagitamab — DRUG
  Mezagitamab injection administered SC.
• Placebo — DRUG
  Mezagitamab-matching placebo injection administered SC.

Study Details

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).

Key Dates

First listed

Dec 9, 2024

Start date

Feb 27, 2025

Status verified

Aug 2026

Primary completion

Mar 16, 2028

Completion

Mar 16, 2028

Study Design

Enrollment

171 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mezagitamab
  Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
• Placebo Comparator: Placebo
  Participants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.

Primary Outcome Measure

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

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (25)

Find similar trials in Hot Springs, AR

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