Clinical trial NCT06005792: 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 the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Psoriasis
Atopic Dermatitis
Keywords: Psoriasis
Plaque Psoriasis
Atopic Dermatitis
Eczema
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
timeFrame: Day 57
Secondary outcomes:
measure: To characterize pharmacokinetics
timeFrame: Day 57
measure: To characterize pharmacodynamics
timeFrame: Day 57
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Executive Medical Director, Clinical Development, Xencor, Inc.
name: Ralph Zitnik, MD
role: STUDY_DIRECTOR
References: