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Monoclonal Antibodies
XmAb27564 for Psoriasis
Phase 1
Waitlist Available
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
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.
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.
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 belowSelect...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
Secondary study objectives
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
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Who is running the clinical trial?
Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,640 Total Patients Enrolled
Ralph Zitnik, MDStudy DirectorExecutive Medical Director, Clinical Development, Xencor, Inc.
1 Previous Clinical Trials
48 Total Patients Enrolled
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