A study to assess the long-term safety and efficacy of dupilumab administered in patients =6 months to <18 year of age with atopic dermatitis (eczema)

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-001396-40-CZ
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-29
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 812

Inclusion Criteria

1. Male or female, =6 months to <18 years of age at the time of screening.
2. Participated in a prior dupilumab study in pediatric patients with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol.

NOTE: Other protocol defined Inclusion criteria apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 812
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who, during their participation in a prior dupilumab study, developed a serious adverse event (SAE) deemed related to study drug, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
2. Patients, who during their participation in a prior dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit.
4. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
5. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
6. Diagnosed active endoparasitic infections or at high risk of these infections
7. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study

Note: Other protocol defined Exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified