A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

Phase 3

Recruiting

• Conditions: Primary Immunodeficiency Diseases (PID)
• Interventions: Biological: TAK-881; Device: SC Investigational Needle Sets

• Registration Number: NCT06076642
• Lead Sponsor: Takeda

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Study Start: 2024-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2029-01-15
• Study Completion: 2029-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-881	TAK-881	Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 subcutaneous (SC) infusion using investigational needle sets at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer \>=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.
TAK-881	SC Investigational Needle Sets	Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 subcutaneous (SC) infusion using investigational needle sets at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer \>=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Up to Week 121
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs	Up to Week 121

Secondary Outcome Measures

Name	Time	Method
Trough Level of Total IgG	Up to Week 121
Doses of TAK-881	Up to Week 121
Treatment Interval of TAK-881	Up to Week 121
Number of Infusions Per Month With Investigational Medical Device Using TAK-881	Up to Week 121
Number of Infusions Sites (Needle Sticks) per Month With Investigational Medical Device Using TAK-881	Up to Week 121
Number of Acute Physician Visits Due to Infection or Other Illnesses	Up to Week 121
Time to First ASBI	Up to Week 121
Duration of Infections	Up to Week 121
Number of Infusions Sites (Needle Sticks) per infusion With Investigational Medical Device Using TAK-881	Up to Week 121
Treatment Preference Measured by a Disease-specific Questionnaire for Participants and the Investigational Medical Device Using TAK-881 in Participants Aged >=12 Years	At Weeks 25 and 73	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.
Number of Participants With Adverse Events (AEs) Related to the Investigational Medical Device	Up to Week 121
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)	Up to Week 121
Duration of Infusions (minutes) With Investigational Medical Device Using TAK-881	Up to Week 121
Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With Investigational Medical Device Using TAK-881	Up to Week 121
Infusion Preparation Time For TAK-881 by Participants/Caregiver	Up to Week 121
Annualized Rate of all Infections	Up to Week 121
Annualized Rate of Episodes of Fever	Up to Week 121
Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20	Up to Week 121
Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years	From Baseline up to Week 121	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.
Number of Hospitalizations With Indications (Infection or other Illnesses)	Up to Week 121
Number of Days of Hospitalization	Up to Week 121
Monthly Infusion Time (minutes/month) With Investigational Medical Device Using TAK-881	Up to Week 121
Infusion Volume per Site (milliliter/site) With Investigational Medical Device Using TAK-881	Up to Week 121
Number of Participants who have Infusions of TAK-881 at Physical Location	Up to Week 121	Physical location includes site/infusion center or home.
Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881	Up to Week 121
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years	From Week 13 up to Week 121	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.
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	Up to Week 121
Number of Days on Antibiotics	Up to Week 121
Infusion Preparation Time For TAK-881 by HCP	Up to Week 121

Trial Locations

Locations (2)

Sneeze, Wheeze, & Itch Associates, LLC; 🇺🇸 Normal, Illinois, United States

Central Georgia Infectious Disease Consultants; 🇺🇸 Macon, Georgia, United States