Moderate-to-Severe Atopic Dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : REGN3500
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational mate
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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: -Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma , Janus kinase inhibitors, azathioprine, methotrexate, etc) -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), hepatitis B virus (HBV) DNA, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The primary endpoint in the study is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics 1. Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (>=50%, >=75%, and >=90% improvement from baseline) at week 16 2. Absolute change in EASI scores from baseline to week 16 3. Proportion of patients with both an IGA score of 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points at week 16 4. Change (absolute and percent) from baseline to week 16 in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) 5. Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS >=4 from baseline at week 16 6. Time to onset of effect on pruritus during the 16-week treatment period (>=4-point reduction of weekly average of daily peak Pruritus NRS from baseline) 7. Percent change from baseline to week 16 in SCORing Atopic Dermatitis (SCORAD) 8. Change from baseline to week 16 in percent Body Surface Area (BSA) of AD involvement | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed