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The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN846 | Drug | Dose 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Activity | To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD. | Week 2 |
| Clinical Activity | To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD. | Week 4 |
| Clinical Activity | To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability a single IV dose of REGN846 | To assess the safety and tolerability of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus. | Week 1 - Week 6 |
| Pharmacokinetic (PK) profile of a single IV dose of REGN846 |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to the following:
Exclusion Criteria:
Exclusion criteria include, but are not limited to the following:
A history of listeriosis.
Presence of any 1 of the following tuberculosis (TB) criteria:
Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
Any clinically significant physical abnormalities observed during the screening visit.
Diabetic, hypertensive, or any known atherosclerotic vascular disease.
Hospitalization for any reason within 60 days of the screening visit.
History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
Known sensitivity to doxycycline or tetracycline.
Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki | Finland | |||||
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To assess the PK profile of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus. |
| Week 1 - Week 6 |
| Immunogenicity of a single IV dose of REGN846 | To assess the immunogenicity of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus. | Week 1 - Week 6 |
| Tampere |
| Finland |
| Berlin | Germany |
| Dresden | Germany |
| Erfurt | Germany |
| Frankfurt | Germany |
| Mahlow | Germany |
| Mainz | Germany |
| Osnabrück | Germany |
| Tübingen | Germany |
| Bydgoszcz | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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