NCT06005792

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2022

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

August 15, 2023

Last Update Submit

November 24, 2025

Conditions

PsoriasisAtopic Dermatitis

Keywords

PsoriasisPlaque PsoriasisAtopic DermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • To characterize pharmacokinetics

    Day 57

  • To characterize pharmacodynamics

    Day 57

Study Arms (2)

Plaque Psoriasis

EXPERIMENTAL
Biological: XmAb27564Biological: Placebo

Atopic Dermatitis

EXPERIMENTAL
Biological: XmAb27564Biological: Placebo

Interventions

XmAb27564BIOLOGICAL

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

Atopic DermatitisPlaque Psoriasis
PlaceboBIOLOGICAL

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

Atopic DermatitisPlaque Psoriasis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Driven Research

Coral Gables, Florida, 33134, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33104, United States

Location

J&S Studies, Inc

College Station, Texas, 77845, United States

Location

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598, United States

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ralph Zitnik, MD

    Executive Medical Director, Clinical Development, Xencor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

October 10, 2022

Primary Completion

March 22, 2024

Study Completion

November 22, 2024

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

US(6)CA(1)