Psoriasis Clinical Trial

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

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.

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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.

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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

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

128

Study ID:

NCT06005792

Recruitment Status:

Active, not recruiting

Sponsor:

Xencor, Inc.

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There are 7 Locations for this study

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Unison Clinical Trials
Sherman Oaks California, 91403, United States
Clinical Trials Research Institute
Thousand Oaks California, 91320, United States
Driven Research
Coral Gables Florida, 33134, United States
San Marcus Research Clinic
Miami Lakes Florida, 33104, United States
J&S Studies, Inc
College Station Texas, 77845, United States
Center for Clinical Studies, LTD. LLP
Webster Texas, 77598, United States
Innovaderm Research Inc.
Montréal Quebec, H2X 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

128

Study ID:

NCT06005792

Recruitment Status:

Active, not recruiting

Sponsor:


Xencor, Inc.

How clear is this clinincal trial information?

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