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

Xencor

Status and phase: Active, not recruiting; Phase 1

Conditions: Atopic Dermatitis; Psoriasis

Treatments: Biological: XmAb27564; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06005792

XmAb27564-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Plaque Psoriasis

Experimental group

Treatment:

Biological: Placebo

Biological: XmAb27564

Atopic Dermatitis

Experimental group

Treatment:

Biological: Placebo

Biological: XmAb27564