TAK-771 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
14Chronic inflammatory demyelinating polyneuropathy2
65Primary immunodeficiency2

14. Chronic inflammatory demyelinating polyneuropathy


Clinical trials : 167 Drugs : 158 - (DrugBank : 38) / Drug target genes : 13 - Drug target pathways : 23
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05084053
(ClinicalTrials.gov)
December 7, 202110/10/2021A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese SubjectsChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP);Multifocal Motor Neuropathy (MMN)Drug: TAK-771TakedaNULLRecruiting18 YearsN/AAll21Phase 3Japan
2JPRN-jRCT2051210110
07/12/202114/10/2021A Study of TAK-771 in Japanese Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese Subjects Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMCohort 1: TAK-771 for CIDP Participants
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.

Cohort 2: TAK-771 for MMN Participants
TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.
Nishizawa AtsushiNULLRecruiting>= 18age oldNot applicableBoth21Phase 3Japan

65. Primary immunodeficiency


Clinical trials : 482 Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031210457
24/01/202227/11/2021A 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) Primary Immunodeficiency Diseases (PID)Epoch 1: TAK-771 Ramp up Period
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI will be increased from 1/3 of full dose to full dose in 3 weeks for participants who will receive TAK-771 once every 3 week, or from 1/4 of full dose to full dose in 6 weeks for participants who will receive TAK-771 once every 4 week.

Epoch 2: TAK-771 Treatment Period
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24.
Nishizawa AtsushiNULLRecruiting>= 2age oldNot applicableBoth15Phase 3Japan
2NCT05150340
(ClinicalTrials.gov)
January 24, 202224/11/2021A 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)Primary Immunodeficiency Diseases (PID)Drug: TAK-771TakedaNULLRecruiting2 YearsN/AAll15Phase 3Japan