Trial Search Results

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

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.

The secondary objectives of the study are:

- To assess the long-term efficacy of dupilumab in pediatric participants with AD

- To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab

Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to <12 years of age with AD

Co-Primary Objectives are:

- To evaluate the pharmacokinetic (PK) of dupilumab PFPs

- To evaluate the safety of dupilumab PFPs

Secondary Objective is:

- To evaluate the immunogenicity of dupilumab PFPs

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi

Stanford Investigator(s):

Intervention(s):

  • Drug: Dupilumab

Phase:

Phase 3

Eligibility


Key Inclusion Criteria:

   - 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

Key Exclusion Criteria:

   - 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

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

   - Severe concomitant illness(es) that, in the investigator's judgment, would adversely
   affect the participant's participation in the study

   - PFP Sub-study Only:

   - 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

   - Switched dupilumab doses within the past 12 weeks

   - 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

Ages Eligible for Study

6 Months - 17 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Dermatology Study
650-743-8520
Not Recruiting