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Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639040
First Posted: July 12, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Condition Intervention Phase
Atopic Dermatitis Drug: Dupilumab Drug: Placebo (for Dupilumab) Other: Topical Corticosteroid (TCS) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to the end of study (up to Day 78) ]
    Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study [up to Day 78]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.


Other Outcome Measures:
  • Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF) [ Time Frame: Day 29 ]
    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.

  • Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4) [ Time Frame: Baseline up to Day 29 ]
    Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).

  • Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29 [ Time Frame: Day 29 ]
    IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).

  • Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF [ Time Frame: Baseline up to Day 29 ]
    IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.

  • Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF [ Time Frame: Baseline up to Day 29 ]
    EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.


Enrollment: 31
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo QW
Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
Drug: Placebo (for Dupilumab)
Placebo (for Dupilumab) once weekly (QW) for 4 weeks
Other: Topical Corticosteroid (TCS)
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Experimental: Dupilumab 300 mg QW
Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
Drug: Dupilumab
Dupilumab 300 mg once weekly (QW) for 4 weeks
Other Names:
  • REGN668
  • SAR231893
  • Dupixent
Other: Topical Corticosteroid (TCS)
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Male and female patients aged 18 years or older
  2. Chronic AD that had been present for at least 2 years

Exclusion Criteria:

  1. Prior treatment with Dupilumab
  2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
  3. AD lesions located on face, flexural, and genital areas
  4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
  5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  6. Treatment with an investigational drug within 8 weeks
  7. Known history of human immunodeficiency virus (HIV) infection
  8. Presence of certain laboratory abnormalities at the screening visit
  9. History of certain opportunistic infections or certain clinical parasite infections
  10. History of malignancy within 5 years before the baseline visit, with certain exceptions
  11. Pregnant or breast-feeding women
  12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
  13. History of alcohol or drug abuse within 2 years of the screening visit
  14. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
  Contacts and Locations
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): NCT01639040


Locations
Germany
Berlin, Germany
Dresden, Germany
Duelmen, Germany
Frankfurt, Germany
Gera, Germany
Langenau, Germany
Munster, Germany
Hungary
Szeged-Hungary, Hungary
Szolnok, Hungary
Poland
Gdansk, Poland
Lodz, Poland
Lublin, Poland
Warszawa, Poland
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Publications:
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01639040     History of Changes
Other Study ID Numbers: R668-AD-1121
First Submitted: July 9, 2012
First Posted: July 12, 2012
Results First Submitted: May 22, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases