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

Sponsor

Xencor, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06005792

Collaborator

(none)

128

Enrollment

Locations

Arms

42.7

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Atopic Dermatitis	Biological: XmAb27564 Biological: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of Hte Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis

Actual Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trials Research Institute	Thousand Oaks	California	United States	91320
2	J&S Studies, Inc	College Station	Texas	United States	77845
3	Clinical Trials of Texas, LLC	San Antonio	Texas	United States	78229
4	Center for Clinical Studies, LTD. LLP	Webster	Texas	United States	77598