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Open-label Study of Dupilumab in Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01949311
Recruitment Status : Active, not recruiting
First Posted : September 24, 2013
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is an open label extension study for patients who participated in placebo-controlled dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety (adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating Scale (NRS).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Dupilumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2678 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Actual Study Start Date : October 10, 2013
Estimated Primary Completion Date : April 6, 2022
Estimated Study Completion Date : April 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Participants will receive repeat doses of dupilumab
Drug: Dupilumab
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893




Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to week 160 ]
    The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs through the last study visit.


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAEs) of special interest [ Time Frame: Day 1 to week 160 ]
    Incidence and rate (events per patient-year) of SAEs of special interest

  2. Number of Adverse Events (AEs) of special interest [ Time Frame: Day 1 to week 160 ]
    Incidence and rate (events per patient-year) of AEs of special interest

  3. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit [ Time Frame: Day 1 to week 160 ]
    Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]

  4. Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  5. Proportion of patients with low disease activity state (eg, IGA ≤2) at each visit [ Time Frame: Day 1 to week 160 ]
  6. Change from baseline in EASI score at each visit [ Time Frame: Day 1 to week 160 ]
  7. Percent change from baseline in EASI score at each visit [ Time Frame: Day 1 to week 160 ]
  8. Proportion of patients with EASI-50 (≥50% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  9. Proportion of patients with EASI-90 (≥90% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  10. Change from baseline in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Day 1 to week 160 ]
    The Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), during a 1-week recall period.

  11. Percent change from baseline in Pruritus NRS [ Time Frame: Day 1 to week 160 ]
    The Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), during a 1-week recall period.

  12. Proportion of patients with improvement (reduction) of Pruritus NRS ≥3 from baseline [ Time Frame: Day 1 to week 160 ]
  13. Proportion of patients with improvement (reduction) of Pruritus NRS ≥4 from baseline [ Time Frame: Day 1 to week 160 ]
  14. Time to first remission (achieving IGA = 0 or 1) [ Time Frame: Day 1 to week 160 ]
  15. Time to first relapse (eg, IGA >2) after remission or to not achieving remission [ Time Frame: Day 1 to week 160 ]
  16. Time to first EASI-50/75/90 [ Time Frame: Day 1 to week 160 ]
  17. Proportion of patients requiring rescue treatment: Overall [ Time Frame: Day 1 to week 160 ]
  18. Proportion of patients requiring rescue treatment: Systemic treatment [ Time Frame: Day 1 to week 160 ]
  19. Proportion of patients requiring rescue treatment: Phototherapy [ Time Frame: Day 1 to week 160 ]
  20. Number of days on topical medication (per patient-year) [ Time Frame: Day 1 to week 160 ]
  21. Proportion of patients using topical medications over various periods during the study [ Time Frame: Day 1 to week 160 ]
  22. Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI) [ Time Frame: Day 1 to week 160 ]
    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL.

  23. Changes from baseline to prespecified time points through the end of the study: Patient Oriented Eczema Measure (POEM) [ Time Frame: Day 1 to week 160 ]
    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults (Charman 2004). The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL.

  24. Changes from baseline to prespecified time points through the end of the study: EuroQol-5D (EQ-5D) [ Time Frame: Day 1 to week 160 ]
    The EQ-5D as a measure of health-related QOL, defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 ordinal levels of severity: "no problem" (1), "some problems" (2), "severe problems" (3). Overall health state is defined as a 5-digit number.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949311


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Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01949311     History of Changes
Other Study ID Numbers: R668-AD-1225
2013-001449-15 ( EudraCT Number )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs