Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of Hte Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis

Conditions
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Psoriasis, Atopic Dermatitis

Intervention / Treatment
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* Biological: XmAb27564
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The main inclusion and exclusion criteria include, but are not limited to, the following: Have active mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis according to study-specific criteria Weight between 40 to 150 kg, inclusive No topical treatments for psoriasis or atopic dermatitis for 2 weeks before randomization No phototherapy for psoriasis for 4 weeks before randomization Washout of oral treatments for psoriasis or atopic dermatitis for 4 weeks before randomization Washout of biologic treatments for psoriasis or atopic dermatitis for 12 weeks before randomization Stated willingness to comply with all study procedures (including skin biopsies) and availability for the duration of the study Exclusion Criteria: Patients with a history of active asthma within 5 years of screening, except those that have well controlled asthma symptoms at screening visit. Patients who have had any prior investigational treatment with IL-2 therapies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plaque Psoriasis<br> | Biological: XmAb27564<br>* Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).<br>Biological: Placebo<br>* Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).<br>|
| Experimental: Atopic Dermatitis<br> | Biological: XmAb27564<br>* Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).<br>Biological: Placebo<br>* Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Psoriasis, Plaque Psoriasis, Atopic Dermatitis