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2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03736967
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD).

Secondary Objectives are to:

  • Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD
  • Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
  • Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: REGN3500 Drug: Dupilumab Drug: REGN3500 + Dupilumab Combo Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: REGN3500 Drug: REGN3500
Administered subcutaneous (SC) every 2 weeks (q2w)

Experimental: Dupilumab Drug: Dupilumab
Administered SC q2w
Other Names:
  • REGN668
  • Dupixent

Experimental: Combo Drug: REGN3500 + Dupilumab Combo
Administered SC q2w
Other Names:
  • REGN668
  • Dupixent

Experimental: Placebo Drug: REGN3500
Administered subcutaneous (SC) every 2 weeks (q2w)

Drug: Dupilumab
Administered SC q2w
Other Names:
  • REGN668
  • Dupixent

Drug: Placebo
Administered SC q2w




Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to week 16 ]
    EASI is a composite index with scores ranging from 0 to 72


Secondary Outcome Measures :
  1. Proportion of patients achieving EASI-50 [ Time Frame: Week 16 ]
    (≥50% improvement from baseline)

  2. Proportion of patients achieving EASI-75 [ Time Frame: Week 16 ]
    (≥75% improvement from baseline)

  3. Proportion of patients achieving EASI-90 [ Time Frame: Week 16 ]
    (≥90% improvement from baseline)

  4. Absolute change in EASI score [ Time Frame: From baseline to week 16 ]
    EASI is a composite index with scores ranging from 0 to 72

  5. Proportion of patients with an Investigator's Global Assessment (IGA) score of 0 or 1 (on a 5-point scale) [ Time Frame: Week 16 ]
  6. Proportion of patients with an IGA score reduction of ≥2 points [ Time Frame: Week 16 ]
  7. Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Week 16 ]
    Range of 0 (No itch) to 10 (Worst imaginable itch)

  8. Percent change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Week 16 ]
  9. Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 [ Time Frame: Week 16 ]
  10. Time to onset of effect on pruritus [ Time Frame: Baseline to Week 16 ]
    ≥4-point reduction of weekly average of daily peak Pruritus NRS

  11. Percent change in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 16 ]
  12. Change in percent body surface area (BSA) of AD involvement [ Time Frame: Baseline to Week 16 ]
  13. Incidence of treatment-emergent adverse events (TEAEs) from baseline through end of week 16 [ Time Frame: Week 16 ]
  14. Incidence of treatment-emergent SAEs from baseline through end of treatment [ Time Frame: Week 16 ]
  15. Incidence of treatment-emergent adverse events of special interest (AESIs) from baseline through end of treatment [ Time Frame: Week 16 ]
  16. Incidence of TEAEs from baseline through end of study [ Time Frame: Week 36 ]
  17. Incidence of treatment-emergent SAEs from baseline through end of study [ Time Frame: Week 36 ]
  18. Incidence of treatment-emergent AESIs from baseline through end of study [ Time Frame: Week 36 ]
  19. Serum REGN 3500 concentration [ Time Frame: Up to Week 36 ]
  20. Serum dupilumab concentration [ Time Frame: Up to Week 36 ]
  21. Anti-REGN3500 antibody [ Time Frame: Up to Week 36 ]
  22. Anti-dupilumab antibody [ Time Frame: Up to Week 36 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  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. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
  4. 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:

  1. Prior participation in a REGN3500 (anti-Interleukin (IL)-33) or dupilumab (anti-IL-4Rα) clinical study; past treatment with or current treatment with dupilumab
  2. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit
  3. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
  4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
  5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
  6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736967


Contacts
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Contact: Clinical Trials Administration 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Research Site Recruiting
Fountain Valley, California, United States, 92708
Regeneron Research Site Recruiting
Long Beach, California, United States, 90808
Regeneron Research Site Recruiting
Los Angeles, California, United States, 90025
Regeneron Research Site Recruiting
Sacramento, California, United States, 95815
United States, Florida
Regeneron Research Site Recruiting
Davie, Florida, United States, 33328
United States, Georgia
Regeneron Research Site Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Maryland
Regeneron Research Site Recruiting
Rockville, Maryland, United States, 20850
United States, Michigan
Regeneron Research Site Recruiting
Bay City, Michigan, United States, 48706
Regeneron Research Site Recruiting
Saint Joseph, Michigan, United States, 49085
United States, New York
Regeneron Research Site Recruiting
Forest Hills, New York, United States, 11375
Regeneron Research Site Recruiting
New York, New York, United States, 10022
United States, North Carolina
Regeneron Research Site Recruiting
High Point, North Carolina, United States, 27262
United States, Oklahoma
Regeneron Research Site Recruiting
Norman, Oklahoma, United States, 73071
United States, Pennsylvania
Regeneron Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03736967     History of Changes
Other Study ID Numbers: R3500-AD-1798
2018-001543-30 ( EudraCT Number )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Moderate
Severe
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs