Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-5669 | Registry Identifier | ICTRP | |
| 2022-000260-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Injection solution Subcutaneous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Dupilumab at Weeks 12 and 24 | Blood samples were collected at specified timepoints to obtain dupilumab concentration. | Weeks 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dermatology of Miami Site Number : 8400015 | Coral Gables | Florida | 33146 | United States | ||
| Treasure Valley Medical Research Site Number : 8400019 |
Not provided
| Label | URL |
|---|---|
| PKM16982 Plain Language Results Summary | View source |
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
A total of 15 participants were enrolled in the study to receive dupilumab at 1 of 4 dose regimens based on the body weight and age.
This study was conducted at 10 sites in Canada, Japan and the United States. A total of 23 participants were screened from 25-Aug-2022 to 02-May-2024 of which 8 were screen failures mainly due to not meeting eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab 200 mg Q4W | Participants received dupilumab 200 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) with no loading dose in children aged >=2 years to <12 years with body weight >=5 kilograms (kg) and <15 kg from Day 1 up to 24 weeks. |
| FG001 | Dupilumab 300 mg Q4W |
| 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 31, 2023 | Nov 6, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks |
| Number of Participants With Anti-drug Antibodies (ADAs) to Dupilumab | Blood samples were collected at specified timepoints and ADA samples were assayed using validated methods. Treatment-emergent ADA response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing. Number of participants with treatment-emergent ADA response is presented. | From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks |
| Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24 | The C-DLQI assesses impact of skin disease on children's health-related quality of life (HRQoL) over the previous week, contains 10 questions related to symptoms feelings associated with disease, impact of disease on leisure, school or holidays, personal relationships, sleep, and side effects of treatment for the skin disease. All questions were scored on 4-point Likert scale:0 (not at all),1 (a little),2 (a lot),3 (very much). Total C-DLQI was calculated by summing the score of each question and ranged from 0 (no impact) to 30 (severe impact). Higher scores indicated poor HRQoL. Mean is presented. Baseline was defined as closest assessment to first study intervention administration on or prior to Day 1 but no later than Day 4. | Baseline (Day 1) and Week 24 |
| Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24 | The IDQOL questionnaire is completed by child's caregiver/guardian with a recall period of 7 days;consists of 10 questions focusing on life quality index (LQI) scored on 4-point Likert scale. An additional question on dermatitis severity is scored on a 5-point Likert scale (0 [none] to 4 [extremely severe]); it is not considered for calculating total IDQOL. For LQI, score ranges are as follows: Questions 1, 5 to 10: 0 (none) to 3 (all the time/very much). Question 2: 0 (happy), 1 (slightly fretful), 2 (very fretful),3 (always crying). Question 3: 0 (0-15 minutes), 1 (15 minutes-1 hour), 2 (1-2 hours),3 (>2 hours).Question 4: 0 (<1 hour), 1 (1-2 hours), 2 (3-4 hours),3 (>=5 hours). IDQOL total score is the sum of the score of each question of LQI, ranges from 0 (no impact) to 30 (maximum impact). Higher scores indicated poor HRQoL. Mean is presented. Baseline was defined as closest assessment to first study intervention administration on or prior to Day 1 but no later than Day 4. | Baseline (Day 1) and Week 24 |
| Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24 | A modified version of the UAS (mUAS) was used for the smaller body surface area of child and adolescent participants. The mUAS was derived from the sum of daily hives severity score (HSS) (ranging from 0 to 3 [0 = absent; 1 = mild {1 to <10 wheals/24 hours}; 2 = moderate: {10 to 30 wheals/24 hours}; and 3 = intense: {>30 wheals/24 hours or large confluent areas of wheals}]) and daily itch severity score (ISS) (ranging from 0 = none to 3 = intense). Daily mUAS total scores range from 0 to 6 (0 to 3 for ISS and 0 to 3 for HSS). Daily mUAS scores were summed over 7-day period to create total score ranging from 0 (no urticaria) to 42 (severe urticaria). Completion of mUAS7 was done by the child or parent(s)/caregiver(s)/legal guardian(s) for participants aged >=4 years and by parent(s)/caregiver(s) for participants aged <4 years. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | Baseline (Day -7 to Day 1) and Week 24 |
| Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 24 | The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | Baseline (Day -7 to Day 1) and Week 24 |
| Change From Baseline in Hive Severity Score Over 7 Days (HSS7) at Week 24 | The HSS7 score is the sum of daily HSS ranging from ranging from 0 to 3 (0 = absent; 1 = mild [1 to <10 wheals/24 hours]; 2 = moderate [10 to 30 wheals/24 hours]; and 3 = intense: [>30 wheals/24 hours or large confluent areas of wheals]) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | Baseline (Day -7 to Day 1) and Week 24 |
| Boise |
| Idaho |
| 83706 |
| United States |
| Washington University School of Medicine- Site Number : 8400004 | St Louis | Missouri | 63110 | United States |
| Boston Childrens Health Physicians Site Number : 8400017 | Hawthorne | New York | 10532 | United States |
| Columbia University Irving Medical Center Site Number : 8400003 | New York | New York | 10032 | United States |
| Childrens Hospital Medical Center of Akron- Site Number : 8400020 | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001 | Cincinnati | Ohio | 45229-3026 | United States |
| Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002 | Tulsa | Oklahoma | 74136 | United States |
| Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005 | Nashville | Tennessee | 37232 | United States |
| Investigational Site Number : 1240009 | Calgary | Alberta | T2W 4X9 | Canada |
| Investigational Site Number : 1240010 | Edmonton | Alberta | T5J 3S9 | Canada |
| Investigational Site Number : 1240007 | Hamilton | Ontario | L8S1G5 | Canada |
| Investigational Site Number : 1240001 | Montreal | Quebec | H4A 3J1 | Canada |
| Investigational Site Number : 3920001 | Yokohama | Kanagawa | 232-8555 | Japan |
| Investigational Site Number : 3920002 | Tsu | Mie-ken | 514-0125 | Japan |
Participants received dupilumab 300 mg SC injection Q4W with no loading dose in children aged >=2 years to <6 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| FG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| FG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection every 2 weeks (Q2W) with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all enrolled participants who took at least 1 dose of the study intervention, regardless of the amount of intervention administered.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab 200 mg Q4W | Participants received dupilumab 200 mg SC injection Q4W with no loading dose in children aged >=2 years to <12 years with body weight >=5 kg and <15 kg from Day 1 up to 24 weeks. |
| BG001 | Dupilumab 300 mg Q4W | Participants received dupilumab 300 mg SC injection Q4W with no loading dose in children aged >=2 years to <6 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| BG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| BG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
| BG004 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | 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 | Serum Concentration of Dupilumab at Weeks 12 and 24 | Blood samples were collected at specified timepoints to obtain dupilumab concentration. | The pharmacokinetic (PK) population included all enrolled and treated participants (safety population) with at least 1 post-baseline PK result. Only those participants with data collected at Weeks 12 or 24 are reported. | Posted | Mean | Standard Deviation | nanogram/milliliter | Weeks 12 and 24 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | The safety population included all enrolled participants who took at least 1 dose of the study intervention, regardless of the amount of intervention administered. | Posted | Count of Participants | Participants | From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) to Dupilumab | Blood samples were collected at specified timepoints and ADA samples were assayed using validated methods. Treatment-emergent ADA response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing. Number of participants with treatment-emergent ADA response is presented. | The ADA population included all enrolled participants treated with dupilumab with at least 1 post-baseline ADA result (positive, negative or inconclusive). | Posted | Count of Participants | Participants | From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24 | The C-DLQI assesses impact of skin disease on children's health-related quality of life (HRQoL) over the previous week, contains 10 questions related to symptoms feelings associated with disease, impact of disease on leisure, school or holidays, personal relationships, sleep, and side effects of treatment for the skin disease. All questions were scored on 4-point Likert scale:0 (not at all),1 (a little),2 (a lot),3 (very much). Total C-DLQI was calculated by summing the score of each question and ranged from 0 (no impact) to 30 (severe impact). Higher scores indicated poor HRQoL. Mean is presented. Baseline was defined as closest assessment to first study intervention administration on or prior to Day 1 but no later than Day 4. | The intent-to-treat (ITT) population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24 | The IDQOL questionnaire is completed by child's caregiver/guardian with a recall period of 7 days;consists of 10 questions focusing on life quality index (LQI) scored on 4-point Likert scale. An additional question on dermatitis severity is scored on a 5-point Likert scale (0 [none] to 4 [extremely severe]); it is not considered for calculating total IDQOL. For LQI, score ranges are as follows: Questions 1, 5 to 10: 0 (none) to 3 (all the time/very much). Question 2: 0 (happy), 1 (slightly fretful), 2 (very fretful),3 (always crying). Question 3: 0 (0-15 minutes), 1 (15 minutes-1 hour), 2 (1-2 hours),3 (>2 hours).Question 4: 0 (<1 hour), 1 (1-2 hours), 2 (3-4 hours),3 (>=5 hours). IDQOL total score is the sum of the score of each question of LQI, ranges from 0 (no impact) to 30 (maximum impact). Higher scores indicated poor HRQoL. Mean is presented. Baseline was defined as closest assessment to first study intervention administration on or prior to Day 1 but no later than Day 4. | The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24 | A modified version of the UAS (mUAS) was used for the smaller body surface area of child and adolescent participants. The mUAS was derived from the sum of daily hives severity score (HSS) (ranging from 0 to 3 [0 = absent; 1 = mild {1 to <10 wheals/24 hours}; 2 = moderate: {10 to 30 wheals/24 hours}; and 3 = intense: {>30 wheals/24 hours or large confluent areas of wheals}]) and daily itch severity score (ISS) (ranging from 0 = none to 3 = intense). Daily mUAS total scores range from 0 to 6 (0 to 3 for ISS and 0 to 3 for HSS). Daily mUAS scores were summed over 7-day period to create total score ranging from 0 (no urticaria) to 42 (severe urticaria). Completion of mUAS7 was done by the child or parent(s)/caregiver(s)/legal guardian(s) for participants aged >=4 years and by parent(s)/caregiver(s) for participants aged <4 years. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day -7 to Day 1) and Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 24 | The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day -7 to Day 1) and Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hive Severity Score Over 7 Days (HSS7) at Week 24 | The HSS7 score is the sum of daily HSS ranging from ranging from 0 to 3 (0 = absent; 1 = mild [1 to <10 wheals/24 hours]; 2 = moderate [10 to 30 wheals/24 hours]; and 3 = intense: [>30 wheals/24 hours or large confluent areas of wheals]) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. Mean is presented. Baseline was defined as sum of the 7 daily measurements obtained within the 7 days prior to first study intervention administration. | The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day -7 to Day 1) and Week 24 |
|
From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks
Analysis was performed on the safety population.
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 | Dupilumab 200 mg Q4W | Participants received dupilumab 200 mg SC injection Q4W with no loading dose in children aged >=2 years to <12 years with body weight >=5 kg and <15 kg from Day 1 up to 24 weeks. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Dupilumab 300 mg Q4W | Participants received dupilumab 300 mg SC injection Q4W with no loading dose in children aged >=2 years to <6 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. | 0 | 8 | 0 | 8 | 7 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Conjunctivitis Bacterial | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Hand-Foot-And-Mouth Disease | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Viral Rash | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Internal Haemorrhage | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Lip Swelling | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Swelling Face | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | #6 | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2024 | Nov 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| >=6 to <12 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Week 24 |
|
|
| OG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks.
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
| OG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
| Dupilumab 300 mg Q4W |
Participants received dupilumab 300 mg SC injection Q4W with no loading dose in children aged >=2 years to <6 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
Participants received dupilumab 300 mg SC injection Q4W with no loading dose in children aged >=2 years to <6 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG002 | Dupilumab 300 mg Q4W, 600 mg Loading Dose | Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|
| Dupilumab 300 mg Q4W, 600 mg Loading Dose |
Participants received dupilumab 300 mg SC injection Q4W with an initial 600 mg loading dose in children aged >=6 years to <12 years with body weight >=15 kg and <30 kg from Day 1 up to 24 weeks. |
| OG003 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | Participants received dupilumab 200 mg SC injection Q2W with an initial 400 mg loading dose in children aged >=2 years to <12 years with body weight >=30 kg and <60 kg from Day 1 up to 24 weeks. |
|
|