A Phase 2 interventional study of LOU064 and placebo in Allergy, Peanut, sponsored by Novartis Pharmaceuticals. Completed at 24 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
This was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 76 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
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.
Drug: LOU064 · Drug: placebo
Placebo was administered orally twice per day, on Days 1 through 28.
Drug: placebo
oral tablets
Also known as: remibrutinib
oral tablets
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
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.
Time frame: Week 4
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
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.
Time frame: Week 4
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
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.
Time frame: Week 4
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
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.
Time frame: Week 4
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
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.
Time frame: 4 weeks
Change From Baseline of Peanut-specific IgE (Including Peanut Components)
IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Time frame: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Time frame: Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
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.
Time frame: Baseline, Day 26
Maximum Observed Blood Concentration (Cmax) of LOU064
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.
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Blood Concentration-time Curve (AUClast) of LOU064
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.
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
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.
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
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.
Time frame: Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
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.
Time frame: 4 weeks
Participants took part in 22 investigative sites in United States.
| Milestone | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| Started | 19 | 19 | 18 | 10 | 10 |
| Pharmacodynamic (pd) analysis set | 19 | 17 | 17 | 7 | 9 |
| Completed | 15 | 18 | 16 | 9 | 8 |
| Not completed | 4 | 1 | 2 | 1 | 2 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol deviation | 2 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Technical problems | 1 | 0 | 1 | 1 | 0 |
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.
| percentage of participants | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo |
|---|---|---|---|---|
| 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 | 50.0 | 86.7 | 0.0 |
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.
| percentage of participants | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| 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 | 43.8 | 80.0 | 100.0 | 0.0 |
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.
| percentage of participants | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| 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 | 43.8 | 46.7 | 33.3 | 0.0 |
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.
| percentage of participants | Placebo + LOU064 25 mg | Placebo |
|---|---|---|
| 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 | 0.0 |
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.
| participants | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| None | 0 | 3 | 1 | 0 | 0 |
| Mild | 5 | 4 | 7 | 2 | 1 |
| Moderate | 8 | 8 | 7 | 3 | 6 |
| Severe | 2 | 1 | 1 | 1 | 0 |
IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
| kU/L | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| Day 25 pre-dose | 2.220 (-0.32 to 35.43) | 1.020 (-4.21 to 92.94) | 2.015 (-117.10 to 143.30) | 5.800 (-0.46 to 86.20) | 11.100 (-31.00 to 85.50) |
| Day 31 (End of Study) | 2.080 (-5.94 to 49.00) | 0.400 (-12.45 to 129.25) | 1.500 (-9.14 to 66.50) | 5.655 (-0.44 to 196.00) | 11.000 (-16.80 to 70.50) |
IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
| mg/L | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| Day 25 pre-dose | 0.010 (-0.22 to 1.75) | 0.000 (-0.46 to 0.22) | 0.000 (-1.52 to 1.23) | 0.000 (-0.22 to 0.06) | 0.000 (-0.22 to 1.62) |
| Day 31 (End of Study) | 0.020 (-0.27 to 1.64) | -0.020 (-0.83 to 0.41) | 0.000 (-1.57 to 0.40) | -0.005 (-0.22 to 0.51) | 0.000 (-0.17 to 1.87) |
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.
| mm | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters | -0.54 ± 2.999 | -1.09 ± 1.879 | -1.16 ± 3.042 | -0.61 ± 1.926 | 2.46 ± 5.200 |
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.
| ng/mL | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg |
|---|---|---|---|---|
| Day 8 | 28.2 ± 20.3 | 44.3 ± 25.6 | 172 ± 107 | — |
| Day 25 | 30.5 ± 16.6 | 40.2 ± 22.9 | 133 ± 76.5 | 71.0 ± 34.7 |
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.
| h*ng/mL | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg |
|---|---|---|---|---|
| Day 8 | 43.5 ± 21.0 | 87.2 ± 56.3 | 308 ± 155 | — |
| Day 25 | 44.0 ± 19.9 | 82.9 ± 57.5 | 261 ± 145 | 135 ± 56.4 |
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.
| h*ng/mL | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg |
|---|---|---|---|---|
| Day 8 | 50.1 ± 20.7 | 91.9 ± 55.6 | 350 ± 176 | — |
| Day 25 | 48.7 ± 22.3 | 70.0 ± 41.8 | 250 ± 159 | 157 ± 65.1 |
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.
| hours | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg |
|---|---|---|---|---|
| Day 8 | 0.542 (0.500 to 3.00) | 1.00 (0.500 to 2.20) | 1.00 (0.520 to 2.00) | — |
| Day 25 | 0.817 (0.500 to 2.00) | 1.00 (0.500 to 2.00) | 1.00 (0.500 to 2.00) | 0.967 (0.500 to 1.30) |
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.
| Participants | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo |
|---|---|---|---|---|---|
| None | 0 | 3 | 1 | 0 | 0 |
| Mild | 5 | 4 | 7 | 2 | 1 |
| Moderate | 8 | 8 | 7 | 3 | 6 |
| Severe | 2 | 1 | 1 | 1 | 0 |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 58 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LOU064 10 mg | 0/19 (0%) | 0/19 (0%) | 10/19 (52.6%) |
| LOU064 25 mg | 0/19 (0%) | 0/19 (0%) | 8/19 (42.1%) |
| LOU064 100 mg | 0/18 (0%) | 0/18 (0%) | 6/18 (33.3%) |
| Placebo + LOU064 25 mg (Placebo Period) | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Placebo + LOU064 25 mg (LOU064 Period) | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Placebo | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Total | 0/76 (0%) | 0/76 (0%) | 38/76 (50%) |
| Event | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg (Placebo Period) | Placebo + LOU064 25 mg (LOU064 Period) | Placebo | Total |
|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/19 | 0/19 | 0/18 | 0/10 | 2/10 | 1/10 | 3/76 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 | 0/18 | 0/10 | 2/10 | 0/10 | 3/76 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 | 1/18 | 0/10 | 1/10 | 2/10 | 5/76 |
| PharyngitisInfections and infestations | 0/19 | 2/19 | 0/18 | 0/10 | 0/10 | 0/10 | 2/76 |
| HeadacheNervous system disorders | 1/19 | 2/19 | 0/18 | 1/10 | 0/10 | 1/10 | 5/76 |
| Abdominal discomfortGastrointestinal disorders | 0/19 | 0/19 | 1/18 | 1/10 | 0/10 | 0/10 | 2/76 |
| NauseaGastrointestinal disorders | 0/19 | 0/19 | 0/18 | 1/10 | 0/10 | 1/10 | 2/76 |
| VomitingGastrointestinal disorders | 1/19 | 0/19 | 0/18 | 0/10 | 1/10 | 0/10 | 2/76 |
| FatigueGeneral disorders | 0/19 | 1/19 | 0/18 | 0/10 | 0/10 | 1/10 | 2/76 |
| PyrexiaGeneral disorders | 0/19 | 0/19 | 0/18 | 0/10 | 0/10 | 1/10 | 1/76 |
| Age, Continuous(years) | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 24.8 ± 7.41 | 27.8 ± 9.93 | 23.6 ± 3.33 | 21.4 ± 3.34 | 25.0 ± 8.88 | 24.9 ± 7.38 |
| Sex: Female, Male(Participants) | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 9 | 5 | 5 | 5 | 4 | 28 |
| Male | 10 | 14 | 13 | 5 | 6 | 48 |
| Race/Ethnicity, Customized(Participants) | LOU064 10 mg | LOU064 25 mg | LOU064 100 mg | Placebo + LOU064 25 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| White | 13 | 15 | 12 | 8 | 7 | 55 |
| Black or African American | 1 | 2 | 3 | 1 | 0 | 7 |
| Asian | 3 | 1 | 3 | 1 | 1 | 9 |
| Multiple | 2 | 1 | 0 | 0 | 2 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Studies of the drug tested here: Remibrutinib