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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06005792
• Other study ID #: XmAb27564-02
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 10, 2022
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montréal	Quebec
United States	J&S Studies, Inc	College Station	Texas
United States	Driven Research	Coral Gables	Florida
United States	San Marcus Research Clinic	Miami Lakes	Florida
United States	Unison Clinical Trials	Sherman Oaks	California
United States	Clinical Trials Research Institute	Thousand Oaks	California
United States	Center for Clinical Studies, LTD. LLP	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xencor, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To characterize pharmacokinetics	Pharmacokinetics will be assessed by serum XmAb27564 concentrations	Day 57
Secondary	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