An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
Optional Sub-Study:
The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.
The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
Key Inclusion Criteria:
Participation in a prior clinical trial of dupilumab for AD and met one of the following:
Willing and able to comply with all clinic visits and study-related procedures
Able to understand and complete study-related questionnaires
Provide signed informed consent
Optional Sub-Study:
Key Exclusion Criteria:
Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
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
Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
Optional Sub-Study:
1. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Ste-Foy, Quebec, Canada
Ste-Foy, Canada
Inashiki-gun, Ibaraki, Japan
Kamimashiki, Kumamoto, Japan
Bunkyo-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Suginami, Tokyo, Japan
Suginami, Tokyo, Japan
Shinagawa-ku, Japan