Brief Summary
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).
The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.
Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.
Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
Brief Title
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Detailed Description
The study consists of two Epochs: Epoch 1 and Epoch 2. In Epoch 1 eligible participants will have the opportunity to receive TAK-881 for a minimum of 6 months. After 6 months in study TAK-881-3002, the results of the anti-rHuPH20 binding antibody assay from either study TAK-881-3001 (NCT05755035) or study TAK-881-3002 (Epoch 1) will be used to determine the next steps in the study:
* Epoch 1: Participants with an anti-rHuPH20 antibody titer less than \[\<\] 1:160 will complete the EOS visit on the day of the first non-investigational product (IP) infusion following Study Visit Week 25.
* Epoch 2: Participants with an anti-rHuPH20 antibody titer greater than or equal to \[\>=\] 1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or study TAK-881-3002 (Epoch 1), will continue with an additional two years of TAK-881 treatment and undergo safety follow-up and will complete the EOS visit on the day of the first non-IP infusion following study Visit Week 121.
* Epoch 1: Participants with an anti-rHuPH20 antibody titer less than \[\<\] 1:160 will complete the EOS visit on the day of the first non-investigational product (IP) infusion following Study Visit Week 25.
* Epoch 2: Participants with an anti-rHuPH20 antibody titer greater than or equal to \[\>=\] 1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or study TAK-881-3002 (Epoch 1), will continue with an additional two years of TAK-881 treatment and undergo safety follow-up and will complete the EOS visit on the day of the first non-IP infusion following study Visit Week 121.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+1-877-825-3327
Central Contact Email
medinfoUS@takeda.com
Completion Date
Completion Date Type
Estimated
Conditions
Primary Immunodeficiency Diseases (PID)
Eligibility Criteria
Inclusion Criteria
Participants who meet ALL of the following criteria are eligible for this study:
* Participant must have completed Study TAK-881-3001 (NCT05755035).
* Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
* Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.
Exclusion Criteria
* Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study.
* New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study.
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 \[NCT05755035\]).
* Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
* Participant is a family member or employee of the investigator or the investigator's site staff.
* Women of childbearing potential who meet any one of the following criteria:-
1. Participant has a positive pregnancy test.
2. Participant does not agree to employ a highly effective form of contraception for the duration of the study.
* If female, participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
Participants who meet ALL of the following criteria are eligible for this study:
* Participant must have completed Study TAK-881-3001 (NCT05755035).
* Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
* Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.
Exclusion Criteria
* Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study.
* New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study.
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 \[NCT05755035\]).
* Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
* Participant is a family member or employee of the investigator or the investigator's site staff.
* Women of childbearing potential who meet any one of the following criteria:-
1. Participant has a positive pregnancy test.
2. Participant does not agree to employ a highly effective form of contraception for the duration of the study.
* If female, participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
Inclusion Criteria
Inclusion Criteria
Participants who meet ALL of the following criteria are eligible for this study:
* Participant must have completed Study TAK-881-3001 (NCT05755035).
* Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
* Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.
Participants who meet ALL of the following criteria are eligible for this study:
* Participant must have completed Study TAK-881-3001 (NCT05755035).
* Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
* Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
2 Years
NCT Id
NCT06076642
Org Class
Industry
Org Full Name
Takeda
Org Study Id
TAK-881-3002
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)
Primary Outcomes
Outcome Measure
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
Outcome Time Frame
Up to Week 121
Secondary Ids
Secondary Id
2023-505946-24-00
Secondary Outcomes
Outcome Time Frame
Up to Week 121
Outcome Measure
Annualized Rate of all Infections
Outcome Time Frame
Up to Week 121
Outcome Measure
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Outcome Time Frame
Up to Week 121
Outcome Measure
Annualized Rate of Episodes of Fever
Outcome Time Frame
Up to Week 121
Outcome Measure
Time to First ASBI
Outcome Time Frame
Up to Week 121
Outcome Measure
Duration of Infections
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20
Outcome Time Frame
Up to Week 121
Outcome Measure
Trough Level of Total IgG
Outcome Time Frame
Up to Week 121
Outcome Measure
Doses of TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Treatment Interval of TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Infusions Per Month With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Infusions Sites (Needle Sticks) per Month With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Infusions Sites (Needle Sticks) per infusion With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Duration of Infusions (minutes) With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Monthly Infusion Time (minutes/month) With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With Investigational Medical Device Using TAK-881
Outcome Time Frame
Up to Week 121
Outcome Measure
Infusion Volume per Site (milliliter/site) With Investigational Medical Device Using TAK-881
Outcome Description
Physical location includes site/infusion center or home.
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Participants who have Infusions of TAK-881 at Physical Location
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881
Outcome Description
TSQM-9 is a 9-item, validated, self-administered instrument to assess participants satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The item scores of each of the 3 domains are summed and transformed to create a total score of 0 (extremely dissatisfied) to 100 (extremely satisfied). Higher score indicates greater satisfaction in that domain.
Outcome Time Frame
From Week 13 up to Week 121
Outcome Measure
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years
Outcome Description
The EQ-5D-5L is a validated, self-administered assessment of overall health designed by the EuroQol Group. The instrument consists of two components: the EQ-5D descriptive system and the standard vertical EQ visual analogue scale (EQ-VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has five response categories: no problems, slight problems, some or moderate problems, severe problems, or extreme problems. Participants will be asked to describe their health state that day by choosing one of 5 responses that reflect the levels of severity for each of the 5 dimensions. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. Higher score indicates best health status.
Outcome Time Frame
From Baseline up to Week 121
Outcome Measure
Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years
Outcome Description
The disease-specific treatment preference questionnaire is a self-administered, non-validated scale to assess participant preference for various attributes of IgG therapy and accompanying devices, such as ease of use of administration of TAK-881 complexity of administration, and convenience. The questionnaire consists of two components. The first component asks participants to indicate the extent to which they like or dislike aspects of TAK-881, including treatment frequency, time, ease, convenience, and complexity. Each item has five response categories: like very much, like, no preference, dislike, and dislike very much. The second component is a single question asking whether they would choose to continue receiving treatment after the trial ends.
Outcome Time Frame
At Weeks 25 and 73
Outcome Measure
Treatment Preference Measured by a Disease-specific Questionnaire for Participants and the Investigational Medical Device Using TAK-881 in Participants Aged >=12 Years
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Days not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or their Treatment or Other Illnesses
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Days on Antibiotics
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Hospitalizations With Indications (Infection or other Illnesses)
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Days of Hospitalization
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Acute Physician Visits Due to Infection or Other Illnesses
Outcome Time Frame
Up to Week 121
Outcome Measure
Infusion Preparation Time For TAK-881 by HCP
Outcome Time Frame
Up to Week 121
Outcome Measure
Infusion Preparation Time For TAK-881 by Participants/Caregiver
Outcome Time Frame
Up to Week 121
Outcome Measure
Number of Participants With Adverse Events (AEs) Related to the Investigational Medical Device
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Arye Rubinstein
Investigator Email
arye.rubinstein@einsteinmed.edu