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Business Decision
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The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic dermatitis.
This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic dermatitis. All patients will receive a total of 4 doses of study drug or placebo, administered subcutaneously every 2 weeks. A one year, open-label extension is available to qualifying patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plaque Psoriasis | Experimental |
| |
| Atopic Dermatitis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb27564 | Biological | Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564 | Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize pharmacokinetics | Pharmacokinetics will be assessed by serum XmAb27564 concentrations | Day 57 |
| To characterize pharmacodynamics | Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood |
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Inclusion Criteria:
The main inclusion and exclusion criteria include, but are not limited to, the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Zitnik, MD | Executive Medical Director, Clinical Development, Xencor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unison Clinical Trials | Sherman Oaks | California | 91403 | United States | ||
| Clinical Trials Research Institute |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
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| Placebo | Biological | Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W). |
|
| Day 57 |
| Thousand Oaks |
| California |
| 91320 |
| United States |
| Driven Research | Coral Gables | Florida | 33134 | United States |
| San Marcus Research Clinic | Miami Lakes | Florida | 33104 | United States |
| J&S Studies, Inc | College Station | Texas | 77845 | United States |
| Center for Clinical Studies, LTD. LLP | Webster | Texas | 77598 | United States |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| 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 |