Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Korábbi kezelés

• Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
• Participants, who during the 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 medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient
• 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
• Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study
• Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study
• Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol.
  • Note: Other protocol defined Inclusion / Exclusion criteria may apply

Más betegség

• Diagnosed active endoparasitic infections or at high risk of these infections

Egyéb

• PFP Sub-study Only:
• Switched dupilumab doses within the past 12 weeks

• Participated in a prior dupilumab study in pediatric participants 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
• PFP Sub-Study Only:
• Age ≥2 to <12 years at time of screening
• Body weight ≥5 kg and <60 kg at time of screening
• Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol