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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06005792
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Xencor, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ralph Zitnik, MD
Principal Investigator Affiliation Executive Medical Director, Clinical Development, Xencor, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Plaque Psoriasis

Experimental: Atopic Dermatitis

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Trials Research Institute, Thousand Oaks, California

Status

Recruiting

Address

Clinical Trials Research Institute

Thousand Oaks, California, 91320

J&S Studies, Inc, College Station, Texas

Status

Recruiting

Address

J&S Studies, Inc

College Station, Texas, 77845

Clinical Trials of Texas, LLC, San Antonio, Texas

Status

Recruiting

Address

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229

Center for Clinical Studies, LTD. LLP, Webster, Texas

Status

Recruiting

Address

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598

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