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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01385657




Registration number
NCT01385657
Ethics application status
Date submitted
9/06/2011
Date registered
30/06/2011
Date last updated
26/02/2020

Titles & IDs
Public title
Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
R668-AD-1026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Dupilumab
Other interventions - Background treatment

Experimental: Placebo - Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22

Experimental: Dupilumab 150 mg - Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22

Experimental: Dupilumab 300 mg - Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22


Treatment: Drugs: Placebo
A total of 4 doses were administered.

Treatment: Drugs: Dupilumab
A total of 4 doses were administered.

Other interventions: Background treatment
Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) - An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study visit [Day 85]). Any TEAE included participants with both serious and non-serious AEs.
Timepoint [1] 0 0
Baseline up to end of study (up to Day 85)
Secondary outcome [1] 0 0
Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax) - Maximum Plasma Concentration of functional Dupilumab observed following the fourth (last) dose.
Timepoint [1] 0 0
Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Secondary outcome [2] 0 0
Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast) - Last Positive (Quantifiable) Concentration of Dupilumab.
Timepoint [2] 0 0
Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85
Secondary outcome [3] 0 0
Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast) - Mean time of last measurable concentration of Dupilumab in actual days.
Timepoint [3] 0 0
Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85

Eligibility
Key inclusion criteria
1. Male or female, 18 years or older;

2. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that
had been present for at least 3 years before the screening visit;

3. Eczema Area and Severity Index (EASI) score = 12 at the screening and baseline visits;

4. Investigator's Global Assessment (IGA) score = 3 at the screening and baseline visits;

5. = 10% body surface area (BSA) of AD involvement at the screening and baseline visits;

6. History of inadequate response to a stable (= 1 month) regimen of topical
corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before
the screening visit.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the
screening visit;

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if
known, whichever is longer, before the baseline visit;

3. Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;

4. Treatment with systemic corticosteroids within 4 weeks before the baseline visit;

5. Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week
before the baseline visit;

6. Systemic treatment for AD with an immunosuppressive/immunomodulating substance within
4 weeks before the baseline visit;

7. Chronic or acute infection requiring treatment with oral or IV antibiotics,
antivirals, or antifungals within 4 weeks before the screening visit or superficial
skin infections within 1 week before the screening visit;

8. Known history of human immunodeficiency virus (HIV) infection;

9. History of clinical parasite infection, other than treated trichomoniasis;

10. History of malignancy within 5 years before the baseline visit, with the following
exceptions: participants with a history of completely treated carcinoma in-situ of
cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;

11. Any medical or psychiatric condition which, in the opinion of the investigator or the
sponsor's medical monitor, would place the participant at risk, interfere with
participation in the study, or interfere with the interpretation of study results;

12. Pregnant or breast-feeding women;

13. Unwilling to use adequate birth control, if of reproductive potential and sexually
active.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- Woolloongabba
Recruitment hospital [3] 0 0
- Carlton
Recruitment hospital [4] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
- Carlton
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Niedersachsen
Country [2] 0 0
Germany
State/province [2] 0 0
Nordrhein-Westfalen
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Gera
Country [5] 0 0
Germany
State/province [5] 0 0
Munster
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Dunedin
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of repeated subcutaneous
(SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
Trial website
https://clinicaltrials.gov/show/NCT01385657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications