NCT05150340

A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)

A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects With Primary Immunodeficiency Diseases (PID)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to check how much TAK-771 stays in their blood over time, side effect from the study treatment or TAK-771, how much TAK-771 participants can receive without getting side effects from it, and if TAK-771 improves symptoms of primary immunodeficiency diseases (PID). This will help the study sponsor (Takeda) to work out the best dose to give people in the future. The participants will be treated with TAK-771 for totally 27 or 30 weeks. Treatment period is consist of two periods called Epoch 1 and Epoch 2. In Epoch 1, different groups of participants will receive lower to higher doses of TAK-771 for 3 to 6 weeks. The study doctors will check for side effects from each dose of TAK-771. In Epoch 2, participants will receive TAK-771 once a 3 or 4 weeks until the end of 24 weeks. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 3, or 4 weeks).

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
DRUG	TAK-771	Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Timeline

• Start date: 2022-01-24
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2021-12-09
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

12 sites across 1 country: Japan