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

NCT03738423 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: R3500-AD-18052018-001544-64
• Study Type: interventional
• Target: 129
• Locations: 11 countries
• Sites: 89

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

Conditions

Atopic Dermatitis

Keywords

Moderate; Severe

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 16

• 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.

  Week 16

Secondary Outcomes (23)

• 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

  Week 16

• 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

  Week 16

• 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

  Week 16

• 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

  Week 16

• 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

  Week 16

Study Arms (5)

Treatment 1

EXPERIMENTAL

Drug: REGN3500; Drug: REGN3500-Matching Placebo

Treatment 2

EXPERIMENTAL

Drug: REGN3500; Drug: REGN3500-Matching Placebo

Treatment 3

EXPERIMENTAL

Drug: REGN3500; Drug: REGN3500-Matching Placebo

Treatment 4

EXPERIMENTAL

Drug: REGN3500; Drug: REGN3500-Matching Placebo

Treatment 5

EXPERIMENTAL

Matching placebo

Drug: REGN3500-Matching Placebo

Interventions

REGN3500 DRUG

Administered subcutaneous (SC)

Treatment 1; Treatment 2; Treatment 3; Treatment 4

REGN3500-Matching Placebo DRUG

Administered subcutaneous (SC)

Treatment 1; Treatment 2; Treatment 3; Treatment 4; Treatment 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (89)

Regeneron Study Site

Birmingham, Alabama, 35209, United States

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Phoenix, Arizona, 85006, United States

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Scottsdale, Arizona, 85259, United States

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Tucson, Arizona, 85718, United States

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Little Rock, Arkansas, 72205, United States

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Fountain Valley, California, 92708, United States

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Fremont, California, 94538, United States

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Oceanside, California, 92056, United States

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Sacramento, California, 95815, United States

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Santa Monica, California, 90404, United States

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Jacksonville, Florida, 32256, United States

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Macon, Georgia, 31217, United States

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Skokie, Illinois, 60077, United States

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Evansville, Indiana, 47714, United States

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Overland Park, Kansas, 66215, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40217, United States

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Louisville, Kentucky, 40241, United States

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Saint Joseph, Michigan, 49085, United States

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Minneapolis, Minnesota, 55402, United States

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Las Vegas, Nevada, 89148, United States

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Lebanon, New Hampshire, 03756, United States

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New York, New York, 10022, United States

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Wilmington, North Carolina, 28405, United States

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Cincinnati, Ohio, 45231, United States

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Norman, Oklahoma, 73071, United States

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North Charleston, South Carolina, 29420, United States

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San Antonio, Texas, 78218, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Norfolk, Virginia, 23502, United States

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Kogarah, 2217, Australia

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Melbourne, 3002, Australia

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Calgary, Alberta, T2G 1B1, Canada

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Hamilton, Ontario, L8S 1G5, Canada

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Hamilton, Ontario, L8S 4K1, Canada

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Toronto, Ontario, M5N 1E3, Canada

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Windsor, Ontario, N8X 2G1, Canada

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Verdun, Quebec, H4G 3E7, Canada

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Brno, 602 00, Czechia

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Náchod, 547 01, Czechia

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Ostrava, 702 00, Czechia

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Prague, 130 00, Czechia

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Bad Bentheim, 48455, Germany

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Berlin, 10117, Germany

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Berlin, 12459, Germany

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Frankfurt, 60590, Germany

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Hamburg, 20537, Germany

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Hanau, 63450, Germany

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Ibbenbueren, 49477, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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München, 80337, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Witten, 58453, Germany

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Orosháza, Bekes County, 5900, Hungary

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Debrecen, Hajdú-Bihar, 4032, Hungary

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Budapest, 84-88, Hungary

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Chūō, 409-3898, Japan

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Hiroshima, 734-8551, Japan

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Kanagawa, 252-0392, Japan

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Kyoto, 602-8566, Japan

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Kyoto, 606-8507, Japan

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Shizuoka, 420-8630, Japan

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Shizuoka, 430-0929, Japan

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Wakayama, 641-8510, Japan

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Yamanashi, 400-8506, Japan

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Krakow, 30-033, Poland

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Lodz, 90-436, Poland

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Szczecin, 71-434, Poland

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Warsaw, 01-817, Poland

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Warsaw, 02-953, Poland

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Wroclaw, 51-318, Poland

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Wroclaw, 51-685, Poland

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Bucheon-si, 14584, South Korea

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Busan, 49241, South Korea

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Gyeonggi-do, 16499, South Korea

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Incheon, 21431, South Korea

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Incheon, 21565, South Korea

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Seoul, 02841, South Korea

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Seoul, 06591, South Korea

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Seoul, 06973, South Korea

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Seoul, 07441, South Korea

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Barakaldo, 48903, Spain

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Córdoba, 14004, Spain

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Madrid, 28041, Spain

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Santiago de Compostela, 15706, Spain

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Sheffield, S10 2JF, United Kingdom

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MeSH Terms

Conditions

Dermatitis, Atopic; Lymphoma, Follicular

Interventions

itepekimab

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; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Limitations and Caveats

The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Participants discontinued study drug and transitioned into the post-treatment follow-up period. As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: November 13, 2018
• Primary Completion: March 13, 2020
• Study Completion: July 24, 2020
• Last Updated: June 10, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-05

Locations

AU (2); PL (7); KR (9); DE (13); ES (4); JP (9); CA (6); GB (1); CZ (4); HU (3); US (31)