NCT06005792

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis
• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	XmAb27564	Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).
BIOLOGICAL	Placebo	Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).

Timeline

• Start date: 2022-10-10
• Primary completion: 2024-03-22
• Completion: 2024-11-22
• First posted: 2023-08-22
• Last updated: 2025-12-02

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study