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

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ClinicalTrials.gov Identifier: NCT03738423
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: REGN3500 Drug: REGN3500-Matching Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : July 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Treatment 1 Drug: REGN3500
Administered subcutaneous (SC)

Drug: REGN3500-Matching Placebo
Administered subcutaneous (SC)

Experimental: Treatment 2 Drug: REGN3500
Administered subcutaneous (SC)

Drug: REGN3500-Matching Placebo
Administered subcutaneous (SC)

Experimental: Treatment 3 Drug: REGN3500
Administered subcutaneous (SC)

Drug: REGN3500-Matching Placebo
Administered subcutaneous (SC)

Experimental: Treatment 4 Drug: REGN3500
Administered subcutaneous (SC)

Drug: REGN3500-Matching Placebo
Administered subcutaneous (SC)

Experimental: Treatment 5
Matching placebo
Drug: REGN3500-Matching Placebo
Administered subcutaneous (SC)




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


Secondary Outcome Measures :
  1. Proportion of participants achieving EASI-50, (≥50% improvement from baseline) [ Time Frame: Week 16 ]
  2. Proportion of participants achieving EASI-75 (≥75% improvement from baseline) [ Time Frame: Week 16 ]
  3. Proportion of participants achieving EASI-90 (≥90% improvement from baseline) [ Time Frame: Week 16 ]
  4. Absolute change in EASI scores [ Time Frame: Week 16 ]
    EASI is a composite index with scores ranging from 0 to 72

  5. Proportion of participants with both an Investigator's Global Assessment (IGA) score of 0 or 1 (on a 5-point scale) and a reduction from baseline of ≥2 points at week 16 [ Time Frame: Week 16 ]
  6. 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)

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

  10. Percent change in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 16 ]
  11. Change in percent body surface area (BSA) of AD involvement [ Time Frame: Baseline to Week 16 ]
  12. Serum REGN3500 concentration [ Time Frame: Up to Week 36 ]
  13. Anti-REGN3500 antibody [ Time Frame: Up to Week 36 ]
  14. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 16 ]
  15. Incidence of treatment-emergent serious adverse events (SAEs) [ Time Frame: Baseline to Week 16 ]
  16. Incidence of treatment-emergent adverse events of special interest (AESIs) [ Time Frame: Baseline to Week 16 ]
  17. Incidence of TEAEs [ Time Frame: Baseline to Week 36 ]
  18. Incidence of SAEs [ Time Frame: Baseline to Week 36 ]
  19. Incidence of AESIs [ Time Frame: Baseline to Week 36 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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 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-γ), 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


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): NCT03738423


Locations
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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: NCT03738423    
Other Study ID Numbers: R3500-AD-1805
2018-001544-64 ( EudraCT Number )
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021

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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