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The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants must have a documented history of inadequate response to topical AD medication(s). Approximately 200 participants were randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity Investigator Global Assessment (IGA) (IGA = 3, moderate; IGA = 4, severe). The study consisted of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab | Experimental | Participants received a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) was administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12. |
|
| Placebo | Placebo Comparator | Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemolizumab | Drug | Nemolizumab was administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) | Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 international unit per milliliter (IU/mL); or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported. | At Week 16 (4 weeks post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) | Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as >= 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 IU/mL; or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination Anti tetanus IgG concentrations < 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (Site#9922) | Phoenix | Arizona | 85018 | United States | ||
| Galderma Investigational Site (Site#8873) |
A total of 242 participants were randomized and out of which only 234 received treatment in the study.
The study was conducted at 42 sites in United states from 05 Mar 2020 to 07 Jul 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemolizumab | Participants received a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2022 | Apr 23, 2025 |
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| Placebo | Drug | Placebo was administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12. |
|
| At Week 16 (4 weeks post-vaccination) |
| Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 | Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay. | At Week 16 |
| Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 | Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay. | At Week 16 |
| Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16 | Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as >= 4-fold increase in SBA reciprocal titer from baseline (using non-imputed values), at Week 16 (4 weeks postvaccination) were reported. | At Week 16 |
| Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16 | Percentage of participants with a positive SBA response to MenC polysaccharide, defined as SBA reciprocal titer >= 8, at Week 16 were reported. Immune response to meningococcal vaccination was determined by measuring functional antibody responses using an SBA assay. | At Week 16 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Galderma Investigational Site (Site#8447) | Fort Smith | Arkansas | 72916 | United States |
| Galderma Investigational Site (Site#8831) | Anaheim | California | 92801 | United States |
| Galderma Investigational Site (Site#8854) | Canoga Park | California | 91303 | United States |
| Galderma Investigational Site (Site#8578) | Cerritos | California | 90703 | United States |
| Galderma Investigational Site (Site#8791) | Fresno | California | 93720 | United States |
| Galderma Investigational Site (Site#8845) | Huntington Beach | California | 92647 | United States |
| Galderma Investigational Site (Site#8833) | Inglewood | California | 90301 | United States |
| Galderma Investigational Site 2 (Site#8833) | Inglewood | California | 90301 | United States |
| Galderma Investigational Site (Site#8858) | Long Beach | California | 90806 | United States |
| Galderma Investigational Site (Site#8130) | Los Angeles | California | 90045 | United States |
| Galderma Investigational Site (Site#8813) | Los Angeles | California | 90057 | United States |
| Galderma Investigational Site (Site#8837) | Pomona | California | 91767 | United States |
| Galderma Investigational Site (SIte#8870) | Boca Raton | Florida | 33433 | United States |
| Galderma Investigational Site (Site#8786) | Clearwater | Florida | 33765 | United States |
| Galderma Investigational Site (Site#8792) | Doral | Florida | 33122 | United States |
| Galderma Investigational Site (Site#8391) | Hialeah | Florida | 33013 | United States |
| Galderma Investigational Site (Site#8836) | Jacksonville | Florida | 32256 | United States |
| Galderma Investigational Site (Site#8850) | Margate | Florida | 33063 | United States |
| Galderma Investigational Site (Site#8851) | Miami | Florida | 33135 | United States |
| Galderma Investigational Site (Site#9921) | Miami Lakes | Florida | 33014 | United States |
| Galderma Investigational Site (Site#8840) | Ocoee | Florida | 34761 | United States |
| Galderma Investigational Site (Site#8788) | Orlando | Florida | 32801 | United States |
| Galderma Investigational Site (Site#8213) | Ormond Beach | Florida | 32174 | United States |
| Galderma Investigational Site (Site#8856) | Ormond Beach | Florida | 32174 | United States |
| Galderma Investigational Site (Site#8856) | Ormond Beach | Florida | 33174 | United States |
| Galderma Investigational Site (Site#8843) | Sweetwater | Florida | 33172 | United States |
| Galderma Investigational Site (Site#8764) | Tampa | Florida | 33613 | United States |
| Galderma Investigational Site 2 (Site#8816) | Tampa | Florida | 33613 | United States |
| Galderma Investigational Site (Site#8839) | Tampa | Florida | 33615 | United States |
| Galderma Investigational Site (Site#8739) | Normal | Illinois | 61761 | United States |
| Galderma Investigational Site (Site#8142) | Indianapolis | Indiana | 46250 | United States |
| Galderma Investigational Site (Site#8532) | Overland Park | Kansas | 66215 | United States |
| Galderma Investigational Site (Site#8812) | Metairie | Louisiana | 70005 | United States |
| Galderma Investigational Site (Site#8793) | Towson | Maryland | 21204 | United States |
| Galderma Investigational Site (Site#8033) | Clinton Township | Michigan | 48038-1137 | United States |
| Galderma Investigational Site (Site#8129) | Fort Gratiot | Michigan | 48059 | United States |
| Galderma Investigational Site (Site#8849) | Troy | Michigan | 48084 | United States |
| Galderma Investigational Site (Site#8876) | Bridgeton | Missouri | 63044 | United States |
| Galderma Investigational Site (Site#8847) | Las Vegas | Nevada | 89118 | United States |
| Galderma Investigational Site (Site#8848) | Las Vegas | Nevada | 89144 | United States |
| Galderma Investigational Site 2 (Site#8864) | Las Vegas | Nevada | 89144 | United States |
| Galderma Investigational Site (Site#8420) | Portsmouth | New Hampshire | 03801 | United States |
| Galderma Investigational Site (Site#9924) | Raritan | New Jersey | 08869 | United States |
| Galderma Investigational Site (Site#8828) | Kew Gardens | New York | 11415 | United States |
| Galderma Investigational Site (Site#9919) | Raleigh | North Carolina | 27617 | United States |
| Galderma Investigational Site (Site#8795) | Shelby | North Carolina | 28150 | United States |
| Galderma Investigational Site (Site#8857) | Oklahoma City | Oklahoma | 73118 | United States |
| Galderma Investigational Site (Site#8841) | Medford | Oregon | 97504 | United States |
| Galderma Investigational Site (Site#8428) | Philadelphia | Pennsylvania | 19104 | United States |
| Galderma Investigational Site (Site#8353) | Yardley | Pennsylvania | 19067 | United States |
| Galderma Investigational Site (Site#8777) | Charleston | South Carolina | 29407 | United States |
| Galderma Investigational Site (Site#8200) | Goodlettsville | Tennessee | 37072 | United States |
| Galderma Investigational Site (Site#8846) | Austin | Texas | 78742 | United States |
| Galderma Investigational Site (Site#8855) | Beaumont | Texas | 77702 | United States |
| Galderma Investigational Site (Site#8245) | Dallas | Texas | 75231 | United States |
| Galderma Investigational Site (Site#8868) | Houston | Texas | 77004 | United States |
| Galderma Investigational Site (Site#8817) | Katy | Texas | 77494 | United States |
| Galderma Investigational Site (Site#8787) | Plano | Texas | 75093 | United States |
| Galderma Investigational Site (Site#8329) | San Antonio | Texas | 78229-3409 | United States |
| Galderma Investigational Site (Site#8003) | Webster | Texas | 77598 | United States |
| Galderma Investigational Site (Site#8844) | Orem | Utah | 84058 | United States |
| Galderma Investigational Site (Site#9935) | Springville | Utah | 84663 | United States |
| Placebo |
Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines at week 12. |
| Modified Intent to Treat (mITT) Population | Modified Intent-to-Treat (mITT) population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. |
|
| Safety Population | The Safety population consisted of all randomized subjects who received at least one administration of study drug. The treatment group assignment in this population was defined by the treatment actually received. This population was used for all the analyses of safety endpoints. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat Population (ITT) population consisted of all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nemolizumab | Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines. |
| BG001 | Placebo | Participants received a placebo (matching to Nemolizumab) via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines. |
| 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 | Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) | Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 international unit per milliliter (IU/mL); or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. | Posted | Number | Percentage of Participants | At Week 16 (4 weeks post-vaccination) |
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| Secondary | Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) | Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as >= 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 IU/mL; or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination Anti tetanus IgG concentrations < 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. | Posted | Number | Percentage of Participants | At Week 16 (4 weeks post-vaccination) |
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| Secondary | Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 | Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. | Posted | Number | Percentage of Participants | At Week 16 |
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| Secondary | Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 | Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. | Posted | Number | Percentage of Participants | At Week 16 |
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| Secondary | Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16 | Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as >= 4-fold increase in SBA reciprocal titer from baseline (using non-imputed values), at Week 16 (4 weeks postvaccination) were reported. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | At Week 16 |
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| Secondary | Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16 | Percentage of participants with a positive SBA response to MenC polysaccharide, defined as SBA reciprocal titer >= 8, at Week 16 were reported. Immune response to meningococcal vaccination was determined by measuring functional antibody responses using an SBA assay. | mITT population consisted of all randomized participants who received at least one dose of study drug and vaccine injection, had an evaluable vaccine response and did not receive any systemic rescue therapy prior to the post-vaccination vaccine response assessment. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | At Week 16 |
|
From Day 1 up to end of study (Week 24)
Safety Population included all randomized participants who received at least one administration of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nemolizumab | Participants received a loading dose of nemolizumab (60 mg) via 2 SC injections at baseline. Nemolizumab (30 mg) administered via a single SC injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines. | 0 | 119 | 0 | 119 | 44 | 119 |
| EG001 | Placebo | Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Participants also received single doses of Tdap and MCV4 vaccines. | 0 | 115 | 1 | 115 | 38 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Superficial inflammatory dermatosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Root canal infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peak expiratory flow rate decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urobilinogen urine increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Penis injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sweat gland tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vaccination site reaction | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | Galderma Research & Development, LLC | 817 961 5000 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2024 | Apr 23, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| 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 |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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 |
|
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| Participants |
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| Counts |
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| Participants |
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|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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