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TAK-919

Phase 1

Coronavirus Disease (COVID-19) | Monoclonal antibody | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: May 3, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04677660A Study of TAK-919 in Healthy Japanese Adults (COVID-19)PHASE1 COMPLETED 200Jan 7, 2021Feb 22, 2022May 3, 20232 Japan
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Study Endpoints
Primary Endpoints
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Up to Day 7 (6 subsequent days after first vaccination on Day 1)

Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Up to Day 35 (6 subsequent days after second vaccination on Day 29)

Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Up to Day 7 (6 subsequent days after first vaccination on Day 1)

Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.

Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Up to Day 35 (6 subsequent days after second vaccination on Day 29)

Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.

Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination
Up to Day 29 (28 days after first vaccination on Day 1)

Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.

Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination
Up to Day 57 (28 days after second vaccination on Day 29)

Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.

Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57
Day 1 up to Day 57

Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.

Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57
Day 1 up to Day 57

MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.

Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
Day 1 up to Day 57

Only unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination was reported in this outcome measure.

Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57
Day 1 up to Day 57

Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 57 was reported in this outcome measure.

Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57
Day 1 up to Day 57
Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57
At Day 57

GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 spike (S) protein.

Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
At Day 57

The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
At Day 57

SCR was defined as percentage of participants with a change from below limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ, OR, greater than or equal to (\>=) 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Secondary Endpoints
Percentage of Participants With SAE Throughout the Trial
Day 1 up to Day 394
Percentage of Participants With MAAEs Throughout the Trial
Day 1 up to Day 394
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial
Day 1 up to Day 394
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
TAK-919EXPERIMENTALTAK-919 0.5 mL, intramuscular injection in the upper arm
PlaceboPLACEBO_COMPARATORTAK-919 Matching Placebo, intramuscular injection in the upper arm
Interventions
NameTypeDescription
TAK-919BIOLOGICALTAK-919 intramuscular injection
PlaceboBIOLOGICALPlacebo intramuscular injection
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Healthy Japanese male and female participants. 2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow up. Exclusion Criteria: 1. Participants who received any other SARS-CoV-2 or other experimental novel c...

Countries:Japan
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