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

Phase 1

Active, not recruiting

• Conditions: Psoriasis; Atopic Dermatitis
• Interventions: Biological: XmAb27564; Biological: Placebo

• Registration Number: NCT06005792
• Lead Sponsor: Xencor, Inc.

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.

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plaque Psoriasis	XmAb27564	-
Atopic Dermatitis	XmAb27564	-
Atopic Dermatitis	Placebo	-
Plaque Psoriasis	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Driven Research; 🇺🇸 Coral Gables, Florida, United States

Unison Clinical Trials; 🇺🇸 Sherman Oaks, California, United States

Clinical Trials Research Institute; 🇺🇸 Thousand Oaks, California, United States

San Marcus Research Clinic; 🇺🇸 Miami Lakes, Florida, United States

J&S Studies, Inc; 🇺🇸 College Station, Texas, United States

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada

Center for Clinical Studies, LTD. LLP; 🇺🇸 Webster, Texas, United States