Trials / Recruiting
RecruitingNCT06722235
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 171 (estimated)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mezagitamab | Mezagitamab injection administered SC. |
| DRUG | Placebo | Mezagitamab placebo-matching injection administered SC. |
Timeline
- Start date
- 2025-02-27
- Primary completion
- 2027-12-28
- Completion
- 2027-12-28
- First posted
- 2024-12-09
- Last updated
- 2026-04-08
Locations
112 sites across 16 countries: United States, Australia, Bulgaria, China, Croatia, France, Greece, Hong Kong, Italy, Japan, Netherlands, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06722235. Inclusion in this directory is not an endorsement.