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Monoclonal Antibodies

XmAb27564 for Psoriasis

Phase 1

Recruiting

Research Sponsored by Xencor, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 57

Awards & highlights

Study Summary

This trial tests the safety and side effects of a new medicine for people with psoriasis and atopic dermatitis.

Who is the study for?

This trial is for individuals with mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis. Participants must weigh between 40 to 150 kg and have not used topical treatments, phototherapy, oral medications, or biologics for their condition within specified time frames before the study starts.Check my eligibility

What is being tested?

The trial is testing XmAb27564 against a placebo in patients with psoriasis or atopic dermatitis. It aims to assess the safety and how well people tolerate multiple doses of this new medication over a period of time.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with clinical trials like this may include skin irritation, allergic reactions, headaches, fatigue, and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have plaque psoriasis or atopic dermatitis ranging from mild to severe.

Select...

My weight is between 40 and 150 kg.

Select...

I haven't taken biologic treatments for my skin condition in the last 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564

Secondary outcome measures

To characterize pharmacodynamics

To characterize pharmacokinetics

Trial Design

2Treatment groups

Experimental Treatment

Group I: Plaque PsoriasisExperimental Treatment2 Interventions

Group II: Atopic DermatitisExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XmAb27564

2021

Completed Phase 1

~50

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,625 Total Patients Enrolled

Ralph Zitnik, MDStudy DirectorExecutive Medical Director, Clinical Development, Xencor, Inc.

1 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if this trial is limited to persons over a certain age?

"This clinical trial will accept participants that are over 18 years of age and have not exceeded 75."

Answered by AI

Do I meet the criteria necessary to be involved in this clinical investigation?

"To qualify, applicants must have a diagnosis of atopic dermatitis and fall within the 18-75 age range. The clinical trial is seeking 128 patients in total."

Answered by AI

To what extent is this trial being conducted in healthcare institutions?

"Several medical facilities are trying to recruit participants for this clinical trial. A few of the sites include J&S Studies, Inc in College Station, Clinical Trials of Texas, LLC in San Antonio and Center for Clinical Studies, LTD LLP located in Webster."

Answered by AI

Has the FDA sanctioned any treatments for Plaque Psoriasis?

"The safety of Plaque psoriasis has been assessed as a 1 due to lacklustre data regarding its efficacy, which is typically expected during Phase 1 trials."

Answered by AI

How many volunteers are contributing to this research endeavor?

"Affirmative. According to the information found on clinicaltrials.gov, this research is still recruiting; It was first published on October 10th 2022 and last revised on August 22nd 2023. This study seeks 128 test subjects from four separate sites."

Answered by AI

Are there available slots in this medical trial for volunteers?

"Confirmed. As per data available on clinicaltrials.gov, this medical trial is still actively recruiting volunteers since its initial posting of October 10th 2022 and most recent update from August 22nd 2023. The study has the capacity to enroll 128 individuals among 4 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005792.

All > Seborrheic Dermatitis > Plaque Psoriasis