Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Participation in a prior clinical trial of dupilumab for AD and met one of the following:
1. Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols
2. Received study treatment in one the studies that have completed last patient, last visit irrespective of duration of participation, provided that patients completed with the instructions received during the study.
3. Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2) but could not be randomized due to randomization closure.
2. Willing and able to comply with all clinic visits and study-related procedures
3. Able to understand and complete study-related questionnaires
4. Provide signed informed consent
Optional Sub-Study:
1. Provide separate informed consent
2. Continuing in the treatment period of the main OLE study
3. Demonstrated compliance with dupilumab therapy, as defined in the protocol
You may not be if
1. 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.
2. 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.
3. 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.).
4. 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
5. 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
Clareo Health | Open-label Study of Dupilumab in Patients With Atopic Dermatitis
