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

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Xencor

Status and phase

Active, not recruiting
Phase 1

Conditions

Atopic Dermatitis
Psoriasis

Treatments

Biological: Placebo
Biological: XmAb27564

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005792
XmAb27564-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 2 patient groups

Plaque Psoriasis
Experimental group
Treatment:
Biological: XmAb27564
Biological: Placebo
Atopic Dermatitis
Experimental group
Treatment:
Biological: XmAb27564
Biological: Placebo

Trial contacts and locations

8

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Central trial contact

Seven Lueder-Powerss; Ralph Zitnik, MD

Data sourced from clinicaltrials.gov

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