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

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ClinicalTrials.gov Identifier: NCT01639040

Recruitment Status : Completed

First Posted : July 12, 2012

Results First Posted : October 13, 2017

Last Update Posted : October 13, 2017

Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Dupilumab Drug: Placebo (for Dupilumab) Other: Topical Corticosteroid (TCS)	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	31 participants
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
Study Start Date :	July 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Atopic dermatitis

MedlinePlus related topics: Eczema Steroids

Drug Information available for: Dupilumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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%

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior treatment with Dupilumab
Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
AD lesions located on face, flexural, and genital areas
Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Treatment with an investigational drug within 8 weeks
Known history of human immunodeficiency virus (HIV) infection
Presence of certain laboratory abnormalities at the screening visit
History of certain opportunistic infections or certain clinical parasite infections
History of malignancy within 5 years before the baseline visit, with certain exceptions
Pregnant or breast-feeding women
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
History of alcohol or drug abuse within 2 years of the screening visit
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 of Results:

Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suárez-Fariñas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.


Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01639040 History of Changes
Other Study ID Numbers:	R668-AD-1121
First Posted:	July 12, 2012 Key Record Dates
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 Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs

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