Trial Outcomes & Findings for Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts (NCT NCT05432388)

Last Updated: 2026-06-12

Results Overview

Responder rate was defined as the percentage of participants tolerating a single dose of \>= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Week 4

Results posted on

2026-06-12

Participant Flow

Participants took part in 22 investigative sites in United States.

The study consisted of a screening period of approximately 4 weeks.

Participant milestones

Participant milestones
Measure	LOU064 10 mg LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Overall Study STARTED	19	19	18	10	10
Overall Study Pharmacodynamic (PD) Analysis Set	19	17	17	7	9
Overall Study COMPLETED	15	18	16	9	8
Overall Study NOT COMPLETED	4	1	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LOU064 10 mg LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Overall Study Physician Decision	1	0	0	0	1
Overall Study Protocol Deviation	2	0	1	0	0
Overall Study Withdrawal by Subject	0	1	0	0	1
Overall Study Technical Problems	1	0	1	1	0

Baseline Characteristics

Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LOU064 10 mg n=19 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=19 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=18 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=10 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=10 Participants Placebo was administered orally twice per day, on Days 1 through 28.	Total n=76 Participants Total of all reporting groups
Age, Continuous	24.8 years STANDARD_DEVIATION 7.41 • n=9 Participants	27.8 years STANDARD_DEVIATION 9.93 • n=27 Participants	23.6 years STANDARD_DEVIATION 3.33 • n=267 Participants	21.4 years STANDARD_DEVIATION 3.34 • n=265 Participants	25.0 years STANDARD_DEVIATION 8.88 • n=568 Participants	24.9 years STANDARD_DEVIATION 7.38 • n=22 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	5 Participants n=27 Participants	5 Participants n=267 Participants	5 Participants n=265 Participants	4 Participants n=568 Participants	28 Participants n=22 Participants
Sex: Female, Male Male	10 Participants n=9 Participants	14 Participants n=27 Participants	13 Participants n=267 Participants	5 Participants n=265 Participants	6 Participants n=568 Participants	48 Participants n=22 Participants
Race/Ethnicity, Customized White	13 Participants n=9 Participants	15 Participants n=27 Participants	12 Participants n=267 Participants	8 Participants n=265 Participants	7 Participants n=568 Participants	55 Participants n=22 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=9 Participants	2 Participants n=27 Participants	3 Participants n=267 Participants	1 Participants n=265 Participants	0 Participants n=568 Participants	7 Participants n=22 Participants
Race/Ethnicity, Customized Asian	3 Participants n=9 Participants	1 Participants n=27 Participants	3 Participants n=267 Participants	1 Participants n=265 Participants	1 Participants n=568 Participants	9 Participants n=22 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	2 Participants n=568 Participants	5 Participants n=22 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Participants in the pharmacodynamic (PD) analysis set from the arms ¨LOU064 10 mg¨, ¨LOU064 25 mg¨, ¨LOU064 100 mg¨ and ¨Placebo¨ who had an available value and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=15 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=7 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms	40.0 percentage of participants	50.0 percentage of participants	86.7 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.

Responder rate was defined as the percentage of participants tolerating a single dose of \>= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=15 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=7 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms	33.3 percentage of participants	43.8 percentage of participants	80.0 percentage of participants	100.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Responder rate was defined as the percentage of participants tolerating a single dose of \>= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=15 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=7 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms	6.7 percentage of participants	43.8 percentage of participants	46.7 percentage of participants	33.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Participants in the pharmacodynamic (PD) analysis set from the arms ¨Placebo+LOU064 25 mg¨ and ¨Placebo¨ who had an available value and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=6 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=7 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo	100.0 percentage of participants	0.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 4 weeks

Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 3000 mg during the DBPCFC conducted at one month, will be categorized as 4 levels: None, Mild, Moderate, Severe.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=15 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=16 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=7 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC Mild	5 participants	4 participants	7 participants	2 participants	1 participants
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC None	0 participants	3 participants	1 participants	0 participants	0 participants
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC Moderate	8 participants	8 participants	7 participants	3 participants	6 participants
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC Severe	2 participants	1 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Day 25 pre-dose and Day 31 (End of Study)

Population: Participants in the pharmacodynamic (PD) analysis set with an available value for the outcome measure. The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.

IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=19 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=17 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=7 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=9 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Change From Baseline of Peanut-specific IgE (Including Peanut Components) Day 25 pre-dose	2.220 kU/L Interval -0.32 to 35.43	1.020 kU/L Interval -4.21 to 92.94	2.015 kU/L Interval -117.1 to 143.3	5.800 kU/L Interval -0.46 to 86.2	11.100 kU/L Interval -31.0 to 85.5
Change From Baseline of Peanut-specific IgE (Including Peanut Components) Day 31 (End of Study)	2.080 kU/L Interval -5.94 to 49.0	0.400 kU/L Interval -12.45 to 129.25	1.500 kU/L Interval -9.14 to 66.5	5.655 kU/L Interval -0.44 to 196.0	11.000 kU/L Interval -16.8 to 70.5

SECONDARY outcome

Timeframe: Baseline, Day 25 pre-dose and Day 31 (End of Study)

IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=19 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=17 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=7 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=9 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components) Day 25 pre-dose	0.010 mg/L Interval -0.22 to 1.75	0.000 mg/L Interval -0.46 to 0.22	0.000 mg/L Interval -1.52 to 1.23	0.000 mg/L Interval -0.22 to 0.06	0.000 mg/L Interval -0.22 to 1.62
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components) Day 31 (End of Study)	0.020 mg/L Interval -0.27 to 1.64	-0.020 mg/L Interval -0.83 to 0.41	0.000 mg/L Interval -1.57 to 0.4	-0.005 mg/L Interval -0.22 to 0.51	0.000 mg/L Interval -0.17 to 1.87

SECONDARY outcome

Timeframe: Baseline, Day 26

An allergen specific skin prick test (SPT) is a commonly used diagnostic tool. In this study a titration SPT using peanut allergen provided additional information on the impact of Bruton's tyrosine kinase (BTK) suppression on skin mast cells. Skin reactions were recorded after 15 minutes of applying allergen to the pricked location. The size of the wheel and flare (the longest diameter and the midpoint orthogonal diameter) at each site were recorded.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=16 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=16 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=7 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo n=7 Participants Placebo was administered orally twice per day, on Days 1 through 28.
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters	-0.54 mm Standard Deviation 2.999	-1.09 mm Standard Deviation 1.879	-1.16 mm Standard Deviation 3.042	-0.61 mm Standard Deviation 1.926	2.46 mm Standard Deviation 5.200

SECONDARY outcome

Timeframe: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.

Population: The PK analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received LOU064 and had no protocol deviations that impacted the PK data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.

Cmax is the maximum (peak) observed blood concentration of LOU064 after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=17 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Maximum Observed Blood Concentration (Cmax) of LOU064 Day 25	30.5 ng/mL Standard Deviation 16.6	40.2 ng/mL Standard Deviation 22.9	133 ng/mL Standard Deviation 76.5	71.0 ng/mL Standard Deviation 34.7	—
Maximum Observed Blood Concentration (Cmax) of LOU064 Day 8	28.2 ng/mL Standard Deviation 20.3	44.3 ng/mL Standard Deviation 25.6	172 ng/mL Standard Deviation 107	—	—

SECONDARY outcome

Timeframe: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.

AUClast is the area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LOU064. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=17 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Area Under Blood Concentration-time Curve (AUClast) of LOU064 Day 8	43.5 h*ng/mL Standard Deviation 21.0	87.2 h*ng/mL Standard Deviation 56.3	308 h*ng/mL Standard Deviation 155	—	—
Area Under Blood Concentration-time Curve (AUClast) of LOU064 Day 25	44.0 h*ng/mL Standard Deviation 19.9	82.9 h*ng/mL Standard Deviation 57.5	261 h*ng/mL Standard Deviation 145	135 h*ng/mL Standard Deviation 56.4	—

SECONDARY outcome

Timeframe: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.

AUCtau is the area under the plasma concentration-time curve. Estimation of AUCtau values required extrapolation of the concentration-time profile from the last measured time-point at 4 h to the end of dosing interval at 12 h post-dose. In some cases, this extrapolation was not possible. For this reason, the number of participants with measurable AUCtau values was less when compared to those with AUClast. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=14 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=12 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=10 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=5 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064 Day 8	50.1 h*ng/mL Standard Deviation 20.7	91.9 h*ng/mL Standard Deviation 55.6	350 h*ng/mL Standard Deviation 176	—	—
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064 Day 25	48.7 h*ng/mL Standard Deviation 22.3	70.0 h*ng/mL Standard Deviation 41.8	250 h*ng/mL Standard Deviation 159	157 h*ng/mL Standard Deviation 65.1	—

SECONDARY outcome

Timeframe: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.

Tmax is the time to reach maximum (peak) of LOU064 blood concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.

Outcome measures

Outcome measures
Measure	LOU064 10 mg n=17 Participants LOU064 10 mg was administered orally twice per day, on Days 1 through 28.	LOU064 25 mg n=16 Participants LOU064 25 mg was administered orally twice per day, on Days 1 through 28.	LOU064 100 mg n=15 Participants LOU064 100 mg was administered orally twice per day, on Days 1 through 28.	Placebo + LOU064 25 mg n=6 Participants Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.	Placebo Placebo was administered orally twice per day, on Days 1 through 28.
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064 Day 8	0.542 hours Interval 0.5 to 3.0	1.00 hours Interval 0.5 to 2.2	1.00 hours Interval 0.52 to 2.0	—	—
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064 Day 25	0.817 hours Interval 0.5 to 2.0	1.00 hours Interval 0.5 to 2.0	1.00 hours Interval 0.5 to 2.0	0.967 hours Interval 0.5 to 1.3	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants in the pharmacodynamic (PD) analysis set with available values for the outcome measure. The PD analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.