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This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab With Auto-Injector (AI) | Experimental | Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters [cm]) apart with AI on Day 0 (injection day). |
|
| Nemolizumab With Dual Chamber Syringe (DCS) | Experimental | Participants received a 60-mg dose of nemolizumab as 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemolizumab | Drug | Nemolizumab with Auto-Injector (AI). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Nemolizumab | Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab | AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab | AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site 7024 | Tempe | Arizona | 85283 | United States | ||
| Galderma Investigational Site 7023 |
A total of 192 participants were randomized in two treatment group. 96 participants received nemolizumab with auto-injector (AI) and remaining 96 participants received nemolizumab with dual chamber syringe (DCS).
The study was conducted at 2 sites in United States from 11 August 2022 to 08 December 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemolizumab With Auto-Injector (AI) | Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters [cm]) apart with AI on Day 0 (injection day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2022 | Nov 13, 2024 |
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| Nemolizumab |
| Drug |
Nemolizumab with Dual-Chamber Syringe (DCS). |
|
| Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab | AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab | Tmax was defined as the time taken to reach the maximum observed serum concentration. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| Half-life (t1/2) of Nemolizumab | t1/2 is defined as time required for the concentration of the drug to reach half of its original value. | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab | ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result. | Pre-dose, Day 29 and 85 post-dose |
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| FG001 | Nemolizumab With Dual Chamber Syringe (DCS) | Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nemolizumab With AI | Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day). |
| BG001 | Nemolizumab With DCS | Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Nemolizumab | Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab. | Analysis was performed on pharmacokinetics (PK) population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
|
|
| ||||||||||||||||||||||||||||
| Primary | Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab | AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration. | Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms*day per milliliter | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab | AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method. | Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms*day per milliliter | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab | AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method. | Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. | Posted | Mean | Standard Deviation | micrograms*day per milliliter | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab | Tmax was defined as the time taken to reach the maximum observed serum concentration. | Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. | Posted | Median | Full Range | days | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Half-life (t1/2) of Nemolizumab | t1/2 is defined as time required for the concentration of the drug to reach half of its original value. | Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab | ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result. | Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Pre-dose, Day 29 and 85 post-dose |
|
From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nemolizumab With AI | Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0. | 0 | 96 | 0 | 96 | 41 | 96 |
| EG001 | Nemolizumab With DCS | Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0. | 0 | 96 | 0 | 96 | 54 | 96 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lip pruritus | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Palatal disorder | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Procedural failure | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Bacterial test | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Procedural anxiety | Psychiatric disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 08179615000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2023 | Jul 24, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612881 | nemolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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