Atopic Dermatitis
Conditions
Brief summary
The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug cocktail representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderate to- severe atopic dermatitis (AD).
Interventions
DRUGNemolizumab
Nemolizumab 30 mg will be administered as SC injections.
DRUGCYP 450 Substrates
CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic atopic dermatitis (AD) for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit * Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at both the screening and baseline visits * IGA score \>= 3 (based on the Investigator's Global Assessment \[IGA\] scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits * AD involvement \>=10 percent (%) of body surface area (BSA) at both the screening and baseline visits * Peak (maximum) pruritus numeric rating scale (PP NRS) score of at least 4.0 at both the screening and baseline visit * Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (topical corticosteroid \[TCS\] with or without topical calcineurin inhibitor \[TCI\])
Exclusion criteria
* Body weight less than (\<) 45 kilogram (kg) * Participants meeting 1 or more of the following criteria at screening or baseline: (a) Had an exacerbation of asthma requiring hospitalization in the preceding 12 months; (b) Reporting asthma that has not been well-controlled in the previous 3 months; (c) Asthma Control Test (ACT) \<= 19 (for those with a history of asthma); (d) Peak expiratory flow \< 80% of the predicted value * Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis * Cutaneous infection within 1 week prior to the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks prior to the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Participants may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods * Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period * Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit * Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to Screening * Known active or latent tuberculosis * Treatment with Biologics and their biosimilars within 8 weeks from Screening * Use of Phototherapy or tanning beds within 4 weeks from Screening * Use of medication known as inducer, inhibitor, or competitive substrate of one or more of the following cytochrome (CYP) enzymes: CYP3A4/5, CYP2C19, CYP2C9, CYD2D6, and CYP1A2 within 2 weeks from Screening * Treatment with Midazolam, Omeprazole, Warfarin Sodium, Metoprolol Tartrate within 2 weeks from Screening * History of hypersensitivity or intolerance to CYP substrates and their excipients * Participants for whom administration of the CYP substrates provided in this study is contraindicated or medically inadvisable * Participants with international normalized ratio (INR) \> 1.5 * Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to baseline: Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice, cranberries or cranberry juice; Vegetables from the mustard green family (eg, broccoli, kale); Charbroiled meats; Beverages, foods, or drugs containing caffeine * History of or current confounding skin condition * Current smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose | AUC (0-infinity) was defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) was the last observed measurable (non-BQL) concentration; and lambda(z) was apparent terminal elimination rate constant. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Change in AUC(0-infinity) of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported. |
| Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose | AUC (0-last) was defined as AUC from time 0 to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Change of AUC(0-last) of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported. |
| Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose | Cmax was defined as the maximum observed plasma concentration. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Cmax of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) | Up to 24 weeks | An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly. |
Countries
Bulgaria, United States
Participant flow
Recruitment details
The study was conducted at 2 sites in the United States and Bulgaria from 08 December 2021 to 07 June 2023.
Pre-assignment details
A total of 48 participants were screened, out of which 17 participants were enrolled in this study and 16 participants received at least 1 dose of nemolizumab.
Participants by arm
| Arm | Count |
|---|---|
| CYP 450 Substrates Plus Nemolizumab Participants received a single oral dose of selected, commercially available, CYP450-S (caffeine 100 mg, warfarin sodium 10 mg, midazolam 2 mg, omeprazole 20 mg, and metoprolol tartrate 100 mg) on Day 1. After a 1-week washout period, participants received a 60 mg loading dose of nemolizumab via 2 consecutive SC 30-mg injections at the Week 1 visit, followed by a single 30-mg injection Q4W at Week 5 and Week 9. Participants received a second oral dosing of CYP450-S at Week 10. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | CYP 450 Substrates Plus Nemolizumab |
|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 7.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
AUC (0-infinity) was defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) was the last observed measurable (non-BQL) concentration; and lambda(z) was apparent terminal elimination rate constant. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Change in AUC(0-infinity) of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported.
Time frame: Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose
Population: Analysis was performed on the per-protocol population, which included all participants who completed the treatment period without any major protocol deviations or any other event that could render the probe drugs plasma concentration-time profiles unreliable. Here, number analyzed signifies the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 932 hour*microgram per liter | Standard Deviation 851 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 20268 hour*microgram per liter | Standard Deviation 5261 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 822 hour*microgram per liter | Standard Deviation 698 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 27.7 hour*microgram per liter | Standard Deviation 1.6 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 27064 hour*microgram per liter | Standard Deviation 16807 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 29.6 hour*microgram per liter | Standard Deviation 15 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 25281 hour*microgram per liter | Standard Deviation 15146 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 976 hour*microgram per liter | Standard Deviation 715 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 845 hour*microgram per liter | Standard Deviation 792 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 20399 hour*microgram per liter | Standard Deviation 4153 |
Comparison: Caffeinep-value: 0.578990% CI: [79.57, 112.45]Mixed Models Analysis
Comparison: Metoprolol Tartratep-value: 0.946890% CI: [83.66, 117.96]Mixed Models Analysis
Comparison: Midazolamp-value: 0.136490% CI: [99.14, 117.24]Mixed Models Analysis
Comparison: Omeprazolep-value: 0.191590% CI: [82.85, 102.44]Mixed Models Analysis
Comparison: Warfarin Sodiump-value: 0.505990% CI: [97.41, 106.12]Mixed Models Analysis
Primary
Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
AUC (0-last) was defined as AUC from time 0 to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Change of AUC(0-last) of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported.
Time frame: Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose
Population: Analysis was performed on the per-protocol population, which included all participants who completed the treatment period without any major protocol deviations or any other event that could render the probe drugs plasma concentration-time profiles unreliable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 25294 hour*microgram per liter | Standard Deviation 15633 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 803 hour*microgram per liter | Standard Deviation 666 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 892 hour*microgram per liter | Standard Deviation 825 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 26.5 hour*microgram per liter | Standard Deviation 12.4 |
| Before Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 18034 hour*microgram per liter | Standard Deviation 4100 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 18068 hour*microgram per liter | Standard Deviation 3470 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 23805 hour*microgram per liter | Standard Deviation 13334 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 820 hour*microgram per liter | Standard Deviation 742 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 28.5 hour*microgram per liter | Standard Deviation 13.9 |
| After Nemolizumab Injections | Change in Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 796 hour*microgram per liter | Standard Deviation 718 |
Comparison: Caffeinep-value: 0.666590% CI: [80.72, 113.75]Mixed Models Analysis
Comparison: Metoprolol Tartratep-value: 0.931690% CI: [83.43, 117.83]Mixed Models Analysis
Comparison: Midazolamp-value: 0.137190% CI: [99.12, 117.13]Mixed Models Analysis
Comparison: Omeprazolep-value: 0.096290% CI: [78.72, 99.85]Mixed Models Analysis
Comparison: Warfarin Sodiump-value: 0.680790% CI: [97.45, 104.29]Mixed Models Analysis
Primary
Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment
Cmax was defined as the maximum observed plasma concentration. Probe drugs included Caffeine, Metoprolol Tartrate, Midazolam, Omeprazole and Warfarin Sodium. Cmax of each of the 5 probe drugs before (Baseline) and after 9-week nemolizumab treatment is reported.
Time frame: Baseline (before nemolizumab injection, at Week 0) and Week 10 (after nemolizumab injection): Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose
Population: Analysis was performed on the per-protocol population, which included all participants who completed the treatment period without any major protocol deviations or any other event that could render the probe drugs plasma concentration-time profiles unreliable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 200 micrograms per liter | Standard Deviation 131 |
| Before Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 374 micrograms per liter | Standard Deviation 205 |
| Before Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 12.8 micrograms per liter | Standard Deviation 5.31 |
| Before Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 695 micrograms per liter | Standard Deviation 159 |
| Before Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 3922 micrograms per liter | Standard Deviation 1563 |
| After Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Warfarin Sodium | 651 micrograms per liter | Standard Deviation 174 |
| After Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Caffeine | 3688 micrograms per liter | Standard Deviation 1512 |
| After Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Metoprolol Tartrate | 187 micrograms per liter | Standard Deviation 114 |
| After Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Midazolam | 11.8 micrograms per liter | Standard Deviation 4.09 |
| After Nemolizumab Injections | Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment | Omeprazole | 349 micrograms per liter | Standard Deviation 290 |
Comparison: Caffeinep-value: 0.343190% CI: [77.3, 107.63]Mixed Models Analysis
Comparison: Metoprolol Tartratep-value: 0.427790% CI: [74.33, 111.53]Mixed Models Analysis
Comparison: Midazolamp-value: 0.496390% CI: [82.8, 108.52]Mixed Models Analysis
Comparison: Omeprazolep-value: 0.193190% CI: [75.08, 103.7]Mixed Models Analysis
Comparison: Warfarin Sodiump-value: 0.29690% CI: [82.51, 104.69]Mixed Models Analysis
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs)
An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.
Time frame: Up to 24 weeks
Population: Analysis was performed on the safety population. The safety population included all participants who received at least 1 dose of nemolizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Before Nemolizumab Injections | Number of Participants With Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) | TEAEs | 0 Participants |
| Before Nemolizumab Injections | Number of Participants With Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) | AESIs | 0 Participants |
| Before Nemolizumab Injections | Number of Participants With Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) | SAEs | 0 Participants |