Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01949311

2013-001449-15 (EudraCT Number)

R668-AD-1225

Details and patient eligibility

About

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.

Enrollment: 2,733 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.).

   *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.

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

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,733 participants in 1 patient group

Dupilumab

Experimental group

Description:

Participants will receive repeat doses of dupilumab

Treatment:

Drug: Dupilumab