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

NCT ID: NCT06005792

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-11-22

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.

Conditions

Psoriasis; Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Plaque Psoriasis

Group Type: EXPERIMENTAL

Placebo

Intervention Type: BIOLOGICAL

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

XmAb27564

Intervention Type: BIOLOGICAL

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

Atopic Dermatitis

Group Type: EXPERIMENTAL

Placebo

Intervention Type: BIOLOGICAL

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

XmAb27564

Intervention Type: BIOLOGICAL

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

Interventions

Placebo

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

Intervention Type: BIOLOGICAL

XmAb27564

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xencor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Zitnik, MD

Role: STUDY_DIRECTOR

Executive Medical Director, Clinical Development, Xencor, Inc.

Locations

Unison Clinical Trials

Sherman Oaks, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Driven Research

Coral Gables, Florida, United States

San Marcus Research Clinic

Miami Lakes, Florida, United States

J&S Studies, Inc

College Station, Texas, United States

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States

Innovaderm Research Inc.

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

XmAb27564-02

Identifier Type: -

Identifier Source: org_study_id