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

• ClinicalTrials.gov Identifier: NCT06005792
• Recruitment Status: Active, not recruiting
• First Posted: August 22, 2023
• Sponsor: Xencor, Inc.
• Information provided by (Responsible Party): Xencor, Inc.

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 (Clinical Trial)
• Estimated 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 the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis
• Actual Study Start Date: October 10, 2022
• Estimated Primary Completion Date: May 2026
• Estimated Study Completion Date: May 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).

Outcome Measures

Primary Outcome Measures :

1. To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564 [ Time Frame: 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 :

1. To characterize pharmacokinetics [ Time Frame: Day 57 ]
   Pharmacokinetics will be assessed by serum XmAb27564 concentrations
2. To characterize pharmacodynamics [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

Unison Clinical Trials

Sherman Oaks, California, United States, 91403

Clinical Trials Research Institute

Thousand Oaks, California, United States, 91320

United States, Florida

Driven Research

Coral Gables, Florida, United States, 33134

San Marcus Research Clinic

Miami Lakes, Florida, United States, 33104

United States, Texas

J&S Studies, Inc

College Station, Texas, United States, 77845

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States, 77598

Canada, Quebec

Innovaderm Research Inc.

Montréal, Quebec, Canada, H2X 2V1

Sponsors and Collaborators

Xencor, Inc.

Investigators

• Study Director: Ralph Zitnik, MD; Executive Medical Director, Clinical Development, Xencor, Inc.

More Information

• Responsible Party: Xencor, Inc.
• ClinicalTrials.gov Identifier: NCT06005792
• Other Study ID Numbers: XmAb27564-02
• First Posted: August 22, 2023
• Last Update Posted: May 16, 2024
• Last Verified: May 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xencor, Inc.:

Psoriasis; Plaque Psoriasis; Atopic Dermatitis; Eczema

Additional relevant MeSH terms:

Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases