PsoriasisPhase 1NCT06005792
Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis
A Phase 1 study testing XmAb27564 in people with Psoriasis and Atopic Dermatitis, run by Xencor, Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- XmAb27564
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Oct 2022to 22 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
J&S Studies, Inc
College Station, Texas, 77845
Driven Research
Coral Gables, Florida, 33134
San Marcus Research Clinic
Miami Lakes, Florida, 33104
Unison Clinical Trials
Sherman Oaks, California, 91403
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis
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.
Read the detailed 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.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- XmAb27564, Placebo
- Keywords
- Psoriasis, Plaque Psoriasis, Atopic Dermatitis, Eczema
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb27564Biological
Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).
PlaceboBiological
Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).
| Study group | Role | What they receive |
|---|---|---|
| Plaque Psoriasis | Experimental | Not described Receives: Biological: XmAb27564; Biological: Placebo |
| Atopic Dermatitis | Experimental | Not described Receives: Biological: XmAb27564; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's
Measured: Day 57
Secondary outcomes (2)
To characterize pharmacokinetics
Pharmacokinetics will be assessed by serum XmAb27564 concentrations
Measured: Day 57
To characterize pharmacodynamics
Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start10 Oct 2022
- Primary completion22 Mar 2024
- Study completion22 Nov 2024
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Zitnik, MD, Study director, Executive Medical Director, Clinical Development, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005792
- Sponsor's protocol ID
- XmAb27564-02
- Status last verified
- Nov 2025
- First submitted
- 15 Aug 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06005792
- Acronym / sponsor ID
- XmAb27564-02
- Conditions
- Psoriasis, Atopic Dermatitis
- Keywords
- Psoriasis, Plaque Psoriasis, Atopic Dermatitis, Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaque Psoriasis | Experimental | Biological: XmAb27564, Biological: Placebo |
| Atopic Dermatitis | Experimental | Biological: XmAb27564, Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb27564Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W). | Biological | Atopic Dermatitis, Plaque Psoriasis |
| PlaceboSubjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W). | Biological | Atopic Dermatitis, Plaque Psoriasis |
Primary outcome
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
Time frame: Day 57
Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's
2 secondary outcomes
To characterize pharmacokinetics
Time frame: Day 57
To characterize pharmacodynamics
Time frame: Day 57
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Zitnik, MD study director
Executive Medical Director, Clinical Development, Xencor, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb27564 in people with Psoriasis and Atopic Dermatitis, run by Xencor, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564 (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.