Back to resultsMultiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis
Primary Purpose
Psoriasis, Atopic Dermatitis
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XmAb27564
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque Psoriasis, Atopic Dermatitis, Eczema
Eligibility 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
Sites / Locations
- Clinical Trials Research InstituteRecruiting
- J&S Studies, IncRecruiting
- Clinical Trials of Texas, LLCRecruiting
- Center for Clinical Studies, LTD. LLPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Plaque Psoriasis
Atopic Dermatitis
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To characterize pharmacokinetics
Pharmacokinetics will be assessed by serum XmAb27564 concentrations
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06005792
Brief Title
Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
Keywords
Psoriasis, Plaque Psoriasis, Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plaque Psoriasis
Arm Type
Experimental
Arm Title
Atopic Dermatitis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
XmAb27564
Intervention Description
Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
Description
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
Time Frame
Day 57
Secondary Outcome Measure Information:
Title
To characterize pharmacokinetics
Description
Pharmacokinetics will be assessed by serum XmAb27564 concentrations
Time Frame
Day 57
Title
To characterize pharmacodynamics
Description
Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood
Time Frame
Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Zitnik, MD
Phone
650 996 5321
Email
rzitnik@xencor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seven Lueder-Powerss
Email
slueder-powers@xencor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Zitnik, MD
Organizational Affiliation
Executive Medical Director, Clinical Development, Xencor, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials Research Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Recruiting
Facility Name
J&S Studies, Inc
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies, LTD. LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis
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