NCT03346434 (Liberty AD) is a Phase 2, PHASE3 clinical trial of Dupilumab in Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.

Who is sponsoring NCT03346434?

NCT03346434 is sponsored by Regeneron Pharmaceuticals.

What drugs are being tested in NCT03346434?

Interventions in NCT03346434: Dupilumab, Matching placebo.

What condition does NCT03346434 study?

NCT03346434 studies Dermatitis, Atopic.

Is NCT03346434 still recruiting?

NCT03346434 is currently completed. Last updated 28 July 2022.

Are results published for NCT03346434?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-28 · How we verify

NCT03346434: Liberty AD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

Completed Phase 2, PHASE3 Results posted Last updated 28 July 2022

What this trial tests

Phase 2, PHASE3 trial testing Dupilumab in Dermatitis, Atopic in 202 participants. Completed in 8 July 2021.

Timeline

30 November 2017

Primary endpoint
8 July 2021

8 July 2021

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	202
Start date	30 November 2017
Primary completion	8 July 2021
Estimated completion	8 July 2021
Sites	48 locations across United Kingdom, United States, Germany, Poland

Drugs / interventions tested

Dupilumab (DUPILUMAB) — full drug profile →
Matching placebo — full drug profile →

Conditions studied

Dermatitis, Atopic — all drugs for Dermatitis, Atopic →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

Adults 6 Months to 5, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Serum concentration of functional dupilumab was reported.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	25.2	± 7.44
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	49.8	± 11.3
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	20.1	± 6.81
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	46.1	± 11.1

Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in Milligrams per Liter/Milligrams per Kilogram (\[mg/L\]/\[mg/kg\]).

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	8.39	± 2.48
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	8.30	± 1.89
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	6.70	± 2.27
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	7.68	± 1.86

Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Tmax was obtained directly from the concentration versus time curve.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	1.97	1.87 – 7.82
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	1.95	1.75 – 3.08
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	2.10	1.80 – 7.99
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	1.92	1.72 – 3.02

Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Clast is the last measurable serum concentration of dupilumab.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	6.64	± 6.16
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	6.14	± 4.69
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	5.64	± 4.52
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	15.1	± 9.48

Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Tlast was defined as the last time point with a measurable serum concentration of dupilumab.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	14.8	6.79 – 28.0
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	26.5	15.0 – 32.0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	8.56	6.88 – 16.9
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	16.0	6.95 – 28.0

Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	198	± 125
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	622	± 184
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	123	± 86.0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	493	± 294

Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab Primary · Post-dose on Days 1, 3, 8, 18, and 29

Dose normalized AUClast was calculated by AUClast/dose.

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	66.0	± 41.6
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	104	± 30.6
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	41.0	± 28.7
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	82.1	± 48.9

Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Primary · Baseline up to Week 4

Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAEs included participants with both SAEs

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	3
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	2
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	7
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	7

Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale Primary · Baseline up to Week 4

Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.

Mild

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	1
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	2
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	4
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	5

Moderate

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	2
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	2
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	2

Severe

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	0
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	1
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	0

Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16 Primary · Week 16

The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. A negative change from baseline indicated improvement. Percentage of participants with IGA score of '0' or '1' is reported.

Group	Value	95% CI
Part B: Placebo + TCS	3.9	-0.42 – 8.21
Part B: Dupilumab 200 mg or 300 mg Q4W + TCS	27.7	18.45 – 38.62

Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 Primary · Week 16

The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicating the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline at Week 16.

Group	Value	95% CI
Part B: Placebo + TCS	10.7	3.65 – 17.74
Part B: Dupilumab 200 mg or 300 mg Q4W + TCS	53.0	41.74 – 64.07

Part A: Number of Participants With Serious TEAEs and Severe TEAEs Secondary · Baseline up to Week 4

Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Severe TEAE: significant impairment of functioning the participant is unable to carry out his or her usual activities.

Participants with serious TEAEs

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	1
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	1
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	0

Participants with severe TEAEs

Group	Value	95% CI
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg	0
Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg	0
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg	1
Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From day of first treatment up to Week 28 (end of study). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg

Serious: 1/10 (10%)

Deaths: 0/10

Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg

Serious: 0/10 (0%)

Deaths: 0/10

Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg

Serious: 1/10 (10%)

Deaths: 0/10

Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg

Serious: 0/10 (0%)

Deaths: 0/10

Part B: Placebo + TCS

Serious: 4/78 (5%)

Deaths: 0/78

Part B: Dupilumab 200 mg or 300 mg Q4W + TCS

Serious: 0/83 (0%)

Deaths: 0/83

Serious adverse events (6 terms)

Reaction	System	Part A: Cohort 1 (≥2 to <6…	Part A: Cohort 1 (≥2 to <6…	Part A: Cohort 2 (≥6 Month…	Part A: Cohort 2 (≥6 Month…	Part B: Placebo + TCS	Part B: Dupilumab 200 mg o…
Anaphylactic reaction	Immune system disorders	—	—	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—	—	—
Cellulitis staphylococcal	Infections and infestations	—	—	—	—	—	—
Dermatitis infected	Infections and infestations	—	—	—	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—	—	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Part A: Cohort 1 (≥2 to <6…	Part A: Cohort 1 (≥2 to <6…	Part A: Cohort 2 (≥6 Month…	Part A: Cohort 2 (≥6 Month…	Part B: Placebo + TCS	Part B: Dupilumab 200 mg o…
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—
Thrombocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—
Teething	Gastrointestinal disorders	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Anaphylactic reaction, Hypersensitivity, Cellulitis staphylococcal, Dermatitis infected, Staphylococcal bacteraemia, Dermatitis atopic.

Data from ClinicalTrials.gov NCT03346434 adverse events section.

Sponsor's own description

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.
Bieber T. · · 2022 · cited 421× · PMID 34417579 · DOI 10.1038/s41573-021-00266-6
Pathophysiology of atopic dermatitis: Clinical implications.
Kim J, Kim BE, Leung DYM. · · 2019 · cited 368× · PMID 30819278 · DOI 10.2500/aap.2019.40.4202
Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial.
Paller AS, Simpson EL, Siegfried EC, Cork MJ, et al · · 2022 · cited 193× · PMID 36116481 · DOI 10.1016/s0140-6736(22)01539-2
Biologics for Treatment of Atopic Dermatitis: Current Status and Future Prospect.
Ratchataswan T, Banzon TM, Thyssen JP, Weidinger S, et al · · 2021 · cited 102× · PMID 33685604 · DOI 10.1016/j.jaip.2020.11.034
Current Insights into Immunology and Novel Therapeutics of Atopic Dermatitis.
Kader HA, Azeem M, Jwayed SA, Al-Shehhi A, et al · · 2021 · cited 61× · PMID 34200009 · DOI 10.3390/cells10061392
A phase 2, open-label study of single-dose dupilumab in children aged 6 months to <6 years with severe uncontrolled atopic dermatitis: pharmacokinetics, safety and efficacy.
Paller AS, Siegfried EC, Simpson EL, Cork MJ, et al · · 2021 · cited 60× · PMID 32893393 · DOI 10.1111/jdv.16928
A review of dupilumab in the treatment of atopic diseases.
Thibodeaux Q, Smith MP, Ly K, Beck K, et al · · 2019 · cited 59× · PMID 30785362 · DOI 10.1080/21645515.2019.1582403
Dupilumab: Mechanism of action, clinical, and translational science.
McCann MR, Kosloski MP, Xu C, Davis JD, et al · · 2024 · cited 52× · PMID 39080841 · DOI 10.1111/cts.13899

Verify or expand the search:

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Currently open trials in the same condition.

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Other Regeneron Pharmaceuticals trials

Trials by the same sponsor.

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NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03346434 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 28 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03346434.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03346434: Liberty AD

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Dupilumab

Other recruiting trials for Dermatitis, Atopic

Other Regeneron Pharmaceuticals trials

Verify against primary sources