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

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Biological: XmAb27564; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• United States
  • California
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Driven Research
    • Miami Lakes, Florida, United States, 33104
      • San Marcus Research Clinic
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD. LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plaque Psoriasis	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).
Experimental: Atopic Dermatitis	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xencor, Inc.
• Investigators: Study Director: Ralph Zitnik, MD, Executive Medical Director, Clinical Development, Xencor, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Atopic Dermatitis; Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Psoriasis; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: XmAb27564-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No