Trial Search Results

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

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 severe atopic dermatitis (AD).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi

Stanford Investigator(s):

Intervention(s):

  • Drug: Dupilumab
  • Drug: Matching placebo

Phase:

Phase 2/Phase 3

Eligibility


Key Inclusion Criteria

   1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria at
   the screening visit

   2. Participants with documented recent history (within 6 months before the screening
   visit) of inadequate response to topical AD medication(s)

   3. IGA = 4 at screening and baseline visits

   4. EASI ≥21 at screening and baseline visits

   5. Body Surface Area (BSA) ≥15% at screening and baseline visits

Key Exclusion Criteria

   1. Participation in a prior dupilumab clinical study

   2. History of important side effects of medium potency topical corticosteroids (only
   applicable for part B of the study)

   3. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the
   baseline visit

   4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

   5. Active chronic or acute infection requiring treatment with systemic antibiotics,
   antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.

   6. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at
   the screening visit

   7. History of malignancy at any time before the baseline visit

   8. Diagnosed active endoparasitic infections or at high risk of these infections

   9. Severe concomitant illness(es) that, in the investigator's judgment, would adversely
   affect the patient's participation in the study

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Ages Eligible for Study

6 Months - 5 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia Tafoya
650-724-1982
Recruiting