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

NCT01639040 | Completed Phase 2 Results DMC

• 1 other identifier: R668-AD-1121
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 13

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

  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.

  Baseline up to the end of study (up to Day 78)

Other Outcomes (5)

• Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)

  Day 29

• Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)

  Baseline up to Day 29

• Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29

  Day 29

Study Arms (2)

Placebo QW

EXPERIMENTAL

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); Other: Topical Corticosteroid (TCS)

Dupilumab 300 mg QW

EXPERIMENTAL

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; Other: Topical Corticosteroid (TCS)

Interventions

Dupilumab DRUG

Dupilumab 300 mg once weekly (QW) for 4 weeks

Also known as: REGN668, SAR231893, Dupixent

Dupilumab 300 mg QW

Placebo (for Dupilumab) DRUG

Placebo (for Dupilumab) once weekly (QW) for 4 weeks

Placebo QW

Topical Corticosteroid (TCS) OTHER

TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

Dupilumab 300 mg QW; Placebo QW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (13)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Dülmen, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Langenau, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Szeged-Hungary, Hungary

Location

Unknown Facility

Szolnok, Hungary

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Related Publications (1)

• Beck LA, Thaci 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, Suarez-Farinas 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.

  PMID: 25006719 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

This was a small safety study that was not adequately powered to assess efficacy.

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 13, 2017
• Results First Posted: October 13, 2017

Record last verified: 2017-05

Locations

PL (4); DE (7); HU (2)