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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03738423




Registration number
NCT03738423
Ethics application status
Date submitted
8/11/2018
Date registered
13/11/2018
Date last updated
10/06/2022

Titles & IDs
Public title
Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to- Severe Atopic Dermatitis
Secondary ID [1] 0 0
2018-001544-64
Secondary ID [2] 0 0
R3500-AD-1805
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 - REGN3500
Treatment: Drugs - REGN3500-Matching Placebo

Experimental: Treatment 1 -

Experimental: Treatment 2 -

Experimental: Treatment 3 -

Experimental: Treatment 4 -

Experimental: Treatment 5 - Matching placebo


Treatment: Drugs: REGN3500
Administered subcutaneous (SC)

Treatment: Drugs: REGN3500-Matching Placebo
Administered subcutaneous (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [=] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [=] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (=90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (=90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of =2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of =2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [14] 0 0
Week 16
Secondary outcome [15] 0 0
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score =4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16
Timepoint [15] 0 0
Week 16
Secondary outcome [16] 0 0
Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score =4 Based on All Observed Values Regardless of Rescue Treatment at Week 16
Timepoint [16] 0 0
Week 16
Secondary outcome [17] 0 0
Time to Onset of Effect on Pruritus (=4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)
Timepoint [17] 0 0
Week 16
Secondary outcome [18] 0 0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16
Timepoint [18] 0 0
Week 16
Secondary outcome [19] 0 0
Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16
Timepoint [19] 0 0
Week 16
Secondary outcome [20] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16
Timepoint [20] 0 0
Up to week 16
Secondary outcome [21] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36
Timepoint [21] 0 0
Up to week 36
Secondary outcome [22] 0 0
Serum Concentration of Functional REGN3500
Timepoint [22] 0 0
Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36
Secondary outcome [23] 0 0
Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)
Timepoint [23] 0 0
Up to week 36

Eligibility
Key inclusion criteria
Key

1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit
2. Eczema Area and Severity Index (EASI) score =16 at the screening and baseline visits
3. IGA score =3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
4. =10% Body surface area (BSA) of AD involvement at the screening and baseline visits
5. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participation in a prior anti-Interleukin (IL)-33 medication clinical study
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
3. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-?), Janus kinase inhibitors, azathioprine, methotrexate, etc)
2. Phototherapy for AD
4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit
7. Known or suspected history of immunosuppression
8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/07/2020
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Regeneron Study Site - Kogarah
Recruitment hospital [2] 0 0
Regeneron Study Site - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Nachod
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha
Country [29] 0 0
Germany
State/province [29] 0 0
Bad Bentheim
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Frankfurt
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Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Hanau
Country [34] 0 0
Germany
State/province [34] 0 0
Ibbenburen
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Germany
State/province [36] 0 0
Lubeck
Country [37] 0 0
Germany
State/province [37] 0 0
Munchen
Country [38] 0 0
Germany
State/province [38] 0 0
Munster
Country [39] 0 0
Germany
State/province [39] 0 0
Tubingen
Country [40] 0 0
Germany
State/province [40] 0 0
Tuebingen
Country [41] 0 0
Germany
State/province [41] 0 0
Witten
Country [42] 0 0
Hungary
State/province [42] 0 0
Bekes
Country [43] 0 0
Hungary
State/province [43] 0 0
Hajdu-Bihar
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Japan
State/province [45] 0 0
Chuo
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Japan
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Hiroshima
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Shizuoka
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Japan
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Wakayama
Country [51] 0 0
Japan
State/province [51] 0 0
Yamanashi
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Bucheon-Si
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Busan
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Gyeonggi-do
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Korea, Republic of
State/province [55] 0 0
Incheon
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Poland
State/province [57] 0 0
Krakow
Country [58] 0 0
Poland
State/province [58] 0 0
Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Szczecin
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Spain
State/province [62] 0 0
Barakaldo
Country [63] 0 0
Spain
State/province [63] 0 0
Cordoba
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Santiago de Compostela
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Sheffield

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 primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD.

Secondary objectives are to:

* Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD
* Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD
* Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD
Trial website
https://clinicaltrials.gov/study/NCT03738423
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03738423