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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06005792

Enrollment

Registered

2023-08-22

Start date

2022-10-10

Completion date

2024-11-22

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Psoriasis

Keywords

Psoriasis, Plaque Psoriasis, Atopic Dermatitis, Eczema

Brief summary

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

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.

Interventions

BIOLOGICALXmAb27564

Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).

BIOLOGICALPlacebo

Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564	Day 57	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

Secondary

Measure	Time frame	Description
To characterize pharmacokinetics	Day 57	Pharmacokinetics will be assessed by serum XmAb27564 concentrations
To characterize pharmacodynamics	Day 57	Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026