A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
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Epoch 1: Participants with an anti-rHuPH20 antibody titer less than [<] 1:160 will complete the EOS visit at the next scheduled IgG infusion following study visit Week 25.
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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 at the next scheduled IgG infusion following study Visit Week 121.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAK-881 Epoch 1: Participants with anti-rHuPH20 antibody titer <1:160 at all-time points during study TAK-881-3001 and study TAK-881-3002 will receive TAK-881 subcutaneous (SC) infusion 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. |
Biological: TAK-881
Participants will receive SC infusion of TAK-881.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- Annualized Rate of all Infections [Up to Week 121]
- Annualized Rate of Acute Serious Bacterial Infections (ASBIs) [Up to Week 121]
- Annualized Rate of Episodes of Fever [Up to Week 121]
- Time to First ASBI [Up to Week 121]
- Duration of Infections [Up to Week 121]
- Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20 [Up to Week 121]
- 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 TAK-881 [Up to Week 121]
- Number of Infusions Sites (Needle Sticks) per Month With TAK-881 [Up to Week 121]
- Number of Infusions Sites (Needle Sticks) per infusion With TAK-881 [Up to Week 121]
- Duration of Infusions (minutes) With TAK-881 [Up to Week 121]
- Monthly Infusion Time (minutes/month) With TAK-881 [Up to Week 121]
- Maximum Infusion Rate per Site (milliliter/hour/site) With TAK-881 [Up to Week 121]
- Infusion Volume per Site (milliliter/site) With 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.
- 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.
- Treatment Preference Measured by a Disease-specific Questionnaire 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 Days Lost From School, Work, Daycare, or to Perform Normal Daily Activities Due To Infection and/or their treatment or other Illnesses (non-Infection) [Up to Week 121]
- Number of Days on Antibiotics [Up to Week 121]
- Number of Hospitalizations With Indications (Infection or other Illnesses) [Up to Week 121]
- Number of Days of Hospitalization [Up to Week 121]
- Number of Acute Physician Visits (Office and Emergency Room) Due to Infection or Other Illnesses [Up to Week 121]
- Infusion Preparation Time For TAK-881 by Nurse/Pharmacist in Participant Aged >=16 Years [Up to Week 121]
Eligibility Criteria
Criteria
Inclusion Criteria
Participants who meet ALL of the following criteria are eligible for this study:
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Participant must have completed Study TAK-881-3001 (NCT05755035).
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If female of childbearing potential, the participant presents with a negative pregnancy test at screening and agrees to employ an acceptable form of contraception for the duration of the study.
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Participant/legally authorized representative is willing and able to comply with the requirements of the protocol.
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Participant/Participant's legally authorized representative has provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated informed consent form (ICF) and/or eConsent, if available), and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria
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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.
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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.
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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]).
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Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
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Participant is a family member or employee of the investigator or the investigator's site staff.
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If female, Participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Takeda
- Takeda Development Center Americas, Inc.
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-881-3002
- 2023-505946-24