Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids) (NCT NCT05526521)

NCT ID: NCT05526521

Last Updated: 2025-11-25

Results Overview

Blood samples were collected at specified timepoints to obtain dupilumab concentration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

Weeks 12 and 24

Results posted on

2025-11-25

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	1	4	2	8
Overall Study COMPLETED	1	3	2	8
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=4 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=8 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Customized >=2 to <6 years	0 Participants n=45 Participants	4 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	4 Participants n=28448 Participants
Age, Customized >=6 to <12 years	1 Participants n=45 Participants	0 Participants n=12929 Participants	2 Participants n=6349 Participants	8 Participants n=4548 Participants	11 Participants n=28448 Participants
Sex: Female, Male Female	1 Participants n=45 Participants	2 Participants n=12929 Participants	2 Participants n=6349 Participants	6 Participants n=4548 Participants	11 Participants n=28448 Participants
Sex: Female, Male Male	0 Participants n=45 Participants	2 Participants n=12929 Participants	0 Participants n=6349 Participants	2 Participants n=4548 Participants	4 Participants n=28448 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants	2 Participants n=4548 Participants	4 Participants n=28448 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	1 Participants n=4548 Participants	1 Participants n=28448 Participants
Race (NIH/OMB) White	0 Participants n=45 Participants	4 Participants n=12929 Participants	1 Participants n=6349 Participants	4 Participants n=4548 Participants	9 Participants n=28448 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	1 Participants n=4548 Participants	1 Participants n=28448 Participants

PRIMARY outcome

Timeframe: Weeks 12 and 24

Population: 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.

Blood samples were collected at specified timepoints to obtain dupilumab concentration.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=8 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=3 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Serum Concentration of Dupilumab at Weeks 12 and 24 Week 12	91600 nanogram/milliliter Standard Deviation 23000	67700 nanogram/milliliter	105000 nanogram/milliliter	45800 nanogram/milliliter Standard Deviation 12400
Serum Concentration of Dupilumab at Weeks 12 and 24 Week 24	78500 nanogram/milliliter Standard Deviation 31600	116000 nanogram/milliliter	141000 nanogram/milliliter Standard Deviation 30100	51100 nanogram/milliliter Standard Deviation 20100

SECONDARY outcome

Timeframe: From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks

Population: The safety population included all enrolled participants who took at least 1 dose of the study intervention, regardless of the amount of intervention administered.

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=8 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=4 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	7 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks

Population: The ADA population included all enrolled participants treated with dupilumab with at least 1 post-baseline ADA result (positive, negative or inconclusive).

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=8 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=3 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Number of Participants With Anti-drug Antibodies (ADAs) to Dupilumab	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The intent-to-treat (ITT) population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported.

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=7 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24	-7.3 score on a scale Standard Deviation 4.3	-3.0 score on a scale	-6.0 score on a scale	-10.5 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported.

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.

Outcome measures

Outcome measures
Measure	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 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.	Dupilumab 300 mg Q4W n=1 Participants 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.	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.
Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24	—	—	-3.0 score on a scale	—

SECONDARY outcome

Timeframe: Baseline (Day -7 to Day 1) and Week 24

Population: The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported.

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=5 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=2 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24	-7.8 score on a scale Standard Deviation 6.6	-8.0 score on a scale	-21.4 score on a scale Standard Deviation 1.9	-2.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline (Day -7 to Day 1) and Week 24

Population: The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported.

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=5 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=2 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 24	-3.4 score on a scale Standard Deviation 3.2	-5.0 score on a scale	-9.6 score on a scale Standard Deviation 3.7	-1.6 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline (Day -7 to Day 1) and Week 24

Population: The ITT population included all enrolled participants. Only those participants with data collected at Baseline and Week 24 are reported.

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.

Outcome measures

Outcome measures
Measure	Dupilumab 200 mg Q2W, 400 mg Loading Dose n=5 Participants 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 200 mg Q4W n=1 Participants 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.	Dupilumab 300 mg Q4W n=2 Participants 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.	Dupilumab 300 mg Q4W, 600 mg Loading Dose n=2 Participants 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.
Change From Baseline in Hive Severity Score Over 7 Days (HSS7) at Week 24	-4.4 score on a scale Standard Deviation 3.6	-3.0 score on a scale	-11.8 score on a scale Standard Deviation 1.8	-1.2 score on a scale Standard Deviation 1.2

Adverse Events

Dupilumab 300 mg Q4W, 600 mg Loading Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dupilumab 200 mg Q2W, 400 mg Loading Dose

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Dupilumab 200 mg Q4W

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dupilumab 300 mg Q4W

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER