TAK-881-3001

Recruiting

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

Clinicaltrials.gov

EU CTIS

#2022-502095-23-01

The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to [>=]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than [<]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.

Interventional Phase 2/Phase 3 clinical trial.

What medical conditions are being studied?

Primary Immunodeficiency Diseases (PID)

What is the clinical trial testing?

TAK-881, HYQVIA

How many participants are being enrolled?

Are placebos part of the clinical trial?

When is the clinical trial being conducted?

Oct 2023 - Sep 2026

How long is participation in the clinical trial?

Participants aged more than and equal to (>=)16 years will be in this study for up to 38 weeks and participants aged 2 to less than (<) 16 years will be in this study for up to 22 weeks.

Sexes

All

Age

2+ Years

Healthy volunteers?

Must be 2 years or older at the time of screening.

Must have been diagnosed with primary humoral immunodeficiency.

Must have received regular IVIG or HYQVIA over a period of at least 12 weeks prior to screening.

Must have serum trough level of immunoglobulin (IgG) more than (>) 5 grams per liter (g/L) at least 1 documented time within 12 weeks prior to screening and at screening.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) of total IgG with TAK-881 and HYQVIA in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Secondary outcome measures

Annualized Rate of all Infections in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Annualized Rate of Episodes of Fever in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Time to First ASBI in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Duration of Infections in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Days Lost From School, Work, Daycare, or to Perform Normal Daily Activities Due To Infection and/or their treatment or other Illnesses [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Days on Antibiotics in Participants [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Hospitalizations With Indications (Infection or other Illnesses) [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Days of Hospitalization [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Acute Physician Visits Due to Infection or Other Illnesses [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Maximum Concentration (Cmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Time to Maximum Concentration (Tmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Terminal half-life (t1/2) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Apparent Clearance (CL/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Apparent Volume of Distribution (Vz/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

AUC0-tau; ss Per Week (AUC0-tau; ss/week) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch]

Maximum Concentration (Cmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

Time to Maximum Concentration (Tmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

Terminal half-life (t1/2) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

Apparent Clearance (CL/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

Apparent Volume of Distribution (Vz/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

AUC0-tau; ss Per Week (AUC0-tau; ss/week) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD [Time Frame: 3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)]

Trough Level of Total IgG in Participants Aged 2 to <16 Years and >=16 Years with PIDD [Time Frame: Up to 27 Weeks (2 to <16 years) and 51 Weeks (>=16 years)]

Trough Level of IgG Subclasses in Participants Aged 2 to <16 Years and >=16 Years with PIDD [Time Frame: Up to 27 Weeks (2 to <16 years) and 51 Weeks (>=16 years)]

Trough Level of Antigen Specific IgG Antibodies in Participants Aged >=16 Years with PIDD [Time Frame: Up to 51 Weeks]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)]

Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Number of Participants With Positive Binding Antibodies (Titer Greater than and equal to [>=] 1:160) and With Positive Neutralizing Antibodies to rHuPH20 [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Duration of Infusions (minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Monthly Infusion (minutes/month) Time at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Number of Infusions Sites (Needle Sticks) per Infusion at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Number of Infusions Sites (Needle Sticks) per Month at Full Dose With Both TAK-881 and HYQVIA in all Participant [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Maximum Infusion Rate per Site (mL/hour/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]

Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants [Time Frame: From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)]