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Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

REGN3500

REGN3500-Matching Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Moderate, Severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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
Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
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 Exclusion Criteria:

Participation in a prior anti-Interleukin (IL)-33 medication clinical study
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
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-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc)
2. Phototherapy for AD
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit
Known or suspected history of immunosuppression
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Treatment 1

Treatment 2

Treatment 3

Treatment 4

Treatment 5

Arm Description

Matching placebo

Outcomes

Primary Outcome Measures

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

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing.

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.

Secondary Outcome Measures

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

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

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.

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

The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported.

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.

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

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). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders.

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

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). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported.

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). 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

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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 with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.

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

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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 with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.

Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)

Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16

BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children).

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16

Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36

AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported.

Serum Concentration of Functional REGN3500

Serum Concentration of Functional REGN3500 was reported.

Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)

Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint.

Full Information

NCT ID

NCT03738423

First Posted

November 8, 2018

Last Updated

May 16, 2022

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03738423

Brief Title

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy

Study Start Date

November 13, 2018 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

July 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Moderate, Severe

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment 1

Arm Type

Experimental

Arm Title

Treatment 2

Arm Type

Experimental

Arm Title

Treatment 3

Arm Type

Experimental

Arm Title

Treatment 4

Arm Type

Experimental

Arm Title

Treatment 5

Arm Type

Experimental

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

REGN3500

Intervention Description

Administered subcutaneous (SC)

Intervention Type

Drug

Intervention Name(s)

REGN3500-Matching Placebo

Intervention Description

Administered subcutaneous (SC)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 16

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Description

Time Frame

Week 16

Title

Description

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported.

Time Frame

Week 16

Title

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

Description

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

Time Frame

Week 16

Title

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

Description

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.

Time Frame

Week 16

Title

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

Description

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

Time Frame

Week 16

Title

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

Description

The EASI score was used to measure the severity and extent of 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. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported.

Time Frame

Week 16

Title

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

Description

The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported.

Time Frame

Week 16

Title

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16

Description

The EASI score was used to measure the severity and extent of AD and measures erythema, induration, 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. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported.

Time Frame

Week 16

Title

Description

Time Frame

Week 16

Title

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

Description

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). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported.

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

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

Description

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). 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

Time Frame

Week 16

Title

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

Description

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.

Time Frame

Week 16

Title

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

Description

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported.

Time Frame

Week 16

Title

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

Description

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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 with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders.

Time Frame

Week 16

Title

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

Description

Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your 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 with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported.

Time Frame

Week 16

Title

Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline)

Description

Time Frame

Week 16

Title

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

Description

Time Frame

Week 16

Title

Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16

Description

Time Frame

Week 16

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16

Description

Time Frame

Up to week 16

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36

Description

Time Frame

Up to week 36

Title

Serum Concentration of Functional REGN3500

Description

Serum Concentration of Functional REGN3500 was reported.

Time Frame

Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36

Title

Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA)

Description

Time Frame

Up to week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits 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 Exclusion Criteria: Participation in a prior anti-Interleukin (IL)-33 medication clinical study Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit 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: Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc) Phototherapy for AD Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit Known or suspected history of immunosuppression History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Note: Other protocol defined Inclusion/Exclusion Criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Study Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Regeneron Study Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Regeneron Study Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Regeneron Study Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Facility Name

Regeneron Study Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Regeneron Study Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Regeneron Study Site

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Regeneron Study Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Regeneron Study Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Regeneron Study Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Regeneron Study Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Regeneron Study Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Regeneron Study Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Regeneron Study Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Regeneron Study Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Regeneron Study Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Regeneron Study Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Regeneron Study Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Regeneron Study Site

City

Saint Joseph

State/Province

Michigan

ZIP/Postal Code

49085

Country

United States

Facility Name

Regeneron Study Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Regeneron Study Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Regeneron Study Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Regeneron Study Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28405

Country

United States

Facility Name

Regeneron Study Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Regeneron Study Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Regeneron Study Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Regeneron Study Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Regeneron Study Site

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Regeneron Study Site

City

Melbourne

ZIP/Postal Code

3002

Country

Australia

Facility Name

Regeneron Study Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Regeneron Study Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 1G5

Country

Canada

Facility Name

Regeneron Study Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Regeneron Study Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5N 1E3

Country

Canada

Facility Name

Regeneron Study Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 2G1

Country

Canada

Facility Name

Regeneron Study Site

City

Verdun

State/Province

Quebec

ZIP/Postal Code

H4G 3E7

Country

Canada

Facility Name

Regeneron Study Site

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Regeneron Study Site

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

Regeneron Study Site

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Regeneron Study Site

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Regeneron Study Site

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Regeneron Study Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Regeneron Study Site

City

Berlin

ZIP/Postal Code

12459

Country

Germany

Facility Name

Regeneron Study Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Regeneron Study Site

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Regeneron Study Site

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Facility Name

Regeneron Study Site

City

Ibbenburen

ZIP/Postal Code

49477

Country

Germany

Facility Name

Regeneron Study Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Regeneron Study Site

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Regeneron Study Site

City

Munchen

ZIP/Postal Code

80337

Country

Germany

Facility Name

Regeneron Study Site

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Regeneron Study Site

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Regeneron Study Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Regeneron Study Site

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

Regeneron Study Site

City

Oroshaza

State/Province

Bekes

ZIP/Postal Code

5900

Country

Hungary

Facility Name

Regeneron Study Site

City

Debrecen

State/Province

Hajdu-Bihar

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Regeneron Study Site

City

Budapest

ZIP/Postal Code

84-88

Country

Hungary

Facility Name

Regeneron Study Site

City

Chuo

ZIP/Postal Code

409-3898

Country

Japan

Facility Name

Regeneron Study Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Regeneron Study Site

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Regeneron Study Site

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Regeneron Study Site

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Regeneron Study Site

City

Shizuoka

ZIP/Postal Code

420-8630

Country

Japan

Facility Name

Regeneron Study Site

City

Shizuoka

ZIP/Postal Code

430-0929

Country

Japan

Facility Name

Regeneron Study Site

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Facility Name

Regeneron Study Site

City

Yamanashi

ZIP/Postal Code

400-8506

Country

Japan

Facility Name

Regeneron Study Site

City

Bucheon-Si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Gyeonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Regeneron Study Site

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Regeneron Study Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Regeneron Study Site

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Regeneron Study Site

City

Warszawa

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Regeneron Study Site

City

Warszawa

ZIP/Postal Code

02-953

Country

Poland

Facility Name

Regeneron Study Site

City

Wroclaw

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Regeneron Study Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Regeneron Study Site

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Regeneron Study Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Regeneron Study Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Regeneron Study Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Regeneron Study Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

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Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial