A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Biological: TAK-881Biological: HYQVIA
- Registration Number
- NCT05755035
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
The study consists of a screening epoch, a ramp-up epoch (if needed) and treatment epochs. Participants who have been receiving conventional subcutaneous intravenous immunoglobin G (cIGSC) or intravenous immunoglobulin G (IGIV) before the study, will enter a ramp-up epoch which will start 1, 2, 3 or 4 weeks after the last cIGSC or IGIV pre study dose before screening. Participants who have already been receiving HYQVIA treatment before the study, will directly enter the treatment epochs after screening. Participants aged greater than or equal to \[\>=\]16 years will be randomized at a 1:1 ratio to one of the following treatment sequences: either TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881. Each participant aged \>=16 years will complete both crossover epochs. Pediatric participants aged 2 to less than \[\<\]16 years will complete a single arm treatment with the study drug (TAK-881 only).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1) HYQVIA Participants aged \>=16 years will receive 6 or 8 infusions at full doses of TAK-881 followed by HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (applicable for participants pre-treated with HYQVIA). Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2) HYQVIA Participants aged \>=16 years will receive 6 or 8 infusions at full doses of HYQVIA followed by TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (applicable for participants pre-treated with HYQVIA). Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2) TAK-881 Participants aged \>=16 years will receive 6 or 8 infusions at full doses of HYQVIA followed by TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (applicable for participants pre-treated with HYQVIA). Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1) TAK-881 Participants aged \>=16 years will receive 6 or 8 infusions at full doses of TAK-881 followed by HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (applicable for participants pre-treated with HYQVIA). Single Arm Treatment Epoch: TAK-881 TAK-881 Pediatric participants aged 2 to \<16 years will receive 6 or 8 infusions at full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their prestudy IgG treatment (applicable for participants pre-treated with HYQVIA).
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method Annualized Rate of all Infections in Participants Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Annualized Rate of Episodes of Fever in Participants Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Duration of Infections in Participants 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 Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Number of Days on Antibiotics in Participants Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Time to First ASBI in Participants Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Apparent Clearance (CL/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD 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 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 Trough Level of Total IgG in Participants Aged 2 to <16 Years and >=16 Years with PIDD 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 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 Up to 51 Weeks Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs 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 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 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 From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years) Maximum Concentration (Cmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD 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 Monthly Infusion (minutes/month) Time at Full Dose With Both TAK-881 and HYQVIA in all Participants From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years) Number of Hospitalizations With Indications (Infection or other Illnesses) Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Number of Acute Physician Visits Due to Infection or Other Illnesses Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Time to Maximum Concentration (Tmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD 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 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 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 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) Number of Participants With Positive Binding Antibodies (Titer Greater than and equal to [>=] 1:160) and With Positive Neutralizing Antibodies to rHuPH20 From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years) Number of Days of Hospitalization Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Apparent Volume of Distribution (Vz/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD 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 TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD 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 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) Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years) Number of Infusions Sites (Needle Sticks) per Month at Full Dose With Both TAK-881 and HYQVIA in all Participant From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years) Apparent Volume of Distribution (Vz/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD 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 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) Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants 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 From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
Trial Locations
- Locations (41)
University of California Irvine Medical Center
🇺🇸Irvine, California, United States
Allergy and Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
National Jewish Medical And Research Center
🇺🇸Denver, Colorado, United States
University of South Florida
🇺🇸Saint Petersburg, Florida, United States
Rush University Medical Center - University Cardiovascular Surgeons
🇺🇸Chicago, Illinois, United States
Louisiana State University Health Science Center-New Orleans
🇺🇸New Orleans, Louisiana, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Duke Asthma, Allergy and Airway Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Nationwide Childrens Hospital
🇺🇸Columbus, Ohio, United States
Allergy Partners of North Texas
🇺🇸Dallas, Texas, United States
Children's Hospital Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)
🇨🇿Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne - ICRC
🇨🇿Brno, Czechia
Fakultni Nemocnice Ostrava (FNO)
🇨🇿Ostrava-Poruba, Czechia
Fakultni Nemocnice v Motole
🇨🇿Prague, Czechia
Aarhus Universitetshospital
🇩🇰Aarhus, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
University Hospital Carl Gustav Carus
🇩🇪Dresden, Germany
Universitatsklinikum Freiburg -Centrum für Chronische Immundefizienz - CCI
🇩🇪Freiburg, Germany
Universitaetsklinikum Tuebingen (UKT)
🇩🇪Tuebingen, Germany
Maastricht Universitair Medisch Centrum (MUMC), Academic Hospital Maastricht
🇳🇱Maastricht, Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht)
🇳🇱Utrecht, Netherlands
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli
🇵🇱Lublin, Lubelskie, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka
🇵🇱Warsaw, Mazowieckie, Poland
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII
🇵🇱Gdansk, Pomorskie, Poland
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
NUDCH (National Institute of Children's Diseases)
🇸🇰Bratislava, Slovakia
OKIA, s.r.o
🇸🇰Kosice, Slovakia
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin
🇸🇰Martin, Slovakia
Hospital Sant Joan de Deu Barcelona
🇪🇸Esplugues De Llobregat, Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
University Hospital La Paz
🇪🇸Madrid, Spain
Central Georgia Infectious Disease Consultants
🇺🇸Macon, Georgia, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
Tanner Clinic
🇺🇸Murray, Utah, United States