XmAb27564 for Psoriasis

No longer recruiting at 8 trial locations

Overseen By Sophie Visonneau

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Xencor, Inc.

Disqualifiers: Active asthma, IL-2 therapies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called XmAb27564 to evaluate its safety and tolerability. The focus is on individuals with plaque psoriasis and atopic dermatitis, conditions that cause red, itchy skin patches. The trial includes two groups, one for each condition. Suitable participants have experienced plaque psoriasis or moderate-to-severe atopic dermatitis and have not recently used specific treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. There is a washout period (time without taking certain medications) of 4 weeks for oral treatments and 12 weeks for biologic treatments for psoriasis or atopic dermatitis before joining the trial.

Is there any evidence suggesting that XmAb27564 is likely to be safe for humans?

Research shows that XmAb27564 has been well-tolerated in earlier trials. One study administered a single dose of a similar drug, XmAb564, to healthy volunteers, and they tolerated it well. This means participants did not experience severe side effects, and the drug had a positive effect on the body. Although the trial for XmAb27564 is in its early stages, information from similar treatments suggests it may also be safe for humans. However, as with any new treatment, researchers are closely monitoring safety. They will carefully observe participants for any side effects to address concerns quickly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Unlike the standard treatments for psoriasis, which often involve topical steroids, phototherapy, or systemic medications like methotrexate, XmAb27564 is unique because it works through a novel mechanism of action. This investigational drug is designed to modulate the immune system more precisely by targeting specific proteins involved in the inflammatory process. Researchers are excited about XmAb27564 because it potentially offers a more targeted approach, which could lead to better efficacy with fewer side effects compared to existing therapies. This precision in targeting could result in significant improvements for patients with plaque psoriasis, providing a new option for those who do not respond well to current treatments.

What evidence suggests that XmAb27564 might be an effective treatment for psoriasis?

Research shows that XmAb27564 could be promising for treating psoriasis and atopic dermatitis, the conditions under study in this trial. Early studies indicate that XmAb27564 is designed to increase regulatory T cells, which help manage inflammation. This is crucial because both psoriasis and atopic dermatitis involve an overactive immune system that causes skin problems. Another study with a similar treatment, tildrakizumab, showed significant improvement in psoriasis patients by targeting a specific protein involved in inflammation. This suggests that XmAb27564 might work similarly by calming the immune system and reducing skin symptoms. Initial results from healthy volunteers showed that XmAb27564 was well tolerated, suggesting it could be safe and effective. ^{1 2 3 4 6}

Who Is on the Research Team?

Ralph Zitnik, MD

Principal Investigator

Executive Medical Director, Clinical Development, Xencor, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and available to follow all study requirements.

I stopped taking oral psoriasis or atopic dermatitis medication 4 weeks ago.

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

Exclusion Criteria

I have asthma, but it has been well controlled for the past 5 years.

You have taken part in a research treatment involving IL-2 therapies before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 doses of XmAb27564 or placebo, administered subcutaneously every 2 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

A one year, open-label extension is available to qualifying patients

1 year

What Are the Treatments Tested in This Trial?

Interventions

• XmAb27564

Trial Overview

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.

How Is the Trial Designed?

Group I: Plaque Psoriasis Experimental Treatment 2 Interventions

Group II: Atopic Dermatitis Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Xencor, Inc.

Lead Sponsor

Trials

31

Recruited

2,500+

Published Research Related to This Trial

Tildrakizumab, a monoclonal antibody targeting the IL-23p19 subunit, showed significant clinical improvement in patients with moderate-to-severe psoriasis, with all subjects achieving a 75% reduction in PASI scores by day 196 in the 3 and 10 mg/kg groups.

In a phase I study involving multiple doses, a majority of subjects (10 out of 15 in the 3 mg/kg group and 13 out of 14 in the 10 mg/kg group) achieved PASI75 by day 112, confirming the efficacy of specific IL-23 inhibition in reducing psoriasis severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical improvement in psoriasis with specific targeting of interleukin-23. Kopp, T., Riedl, E., Bangert, C., et al.[2019]

In a phase IIIb study involving 119 patients with moderate-to-severe plaque psoriasis, guselkumab was significantly more effective than fumaric acid esters (FAE), achieving a PASI 90 response in 82% of patients compared to only 14% for FAE at week 24.

Guselkumab also had a better safety profile, with a lower incidence of adverse events (73% vs. 98% for FAE) and no patients discontinuing treatment due to side effects, highlighting its potential as a safer option for systemic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS). Thaçi, D., Pinter, A., Sebastian, M., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06005792

NCT06005792 | Multiple Ascending-Dose Study of XmAb® ...

The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic ...

2.

investors.xencor.com

investors.xencor.com/news-releases/news-release-details/xencor-presents-clinical-results-phase-1a-study-xmabr564-eular

Xencor Presents Clinical Results from Phase 1a Study of ...

A single dose of XmAb564 was well tolerated in healthy volunteers and generates durable, dose-dependent and selective expansion of regulatory T cells.

3.

withpower.com

withpower.com/trial/phase-1-dermatitis-dermatitis-atopic-9-2022-5db32

XmAb27564 for Psoriasis · Info for Participants

The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10111960/

A systematic review of interleukin-2-based ...

Through a systematic review of improved IL-2 compounds in clinical development, combined with structural and mechanistic data on these compounds, we summarize ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36994947/

Efficacy and safety of lebrikizumab in moderate-to-severe ...

After a 16-week induction period with lebrikizumab Q2W, lebrikizumab Q2W and Q4W maintained similar improvement of the signs and symptoms of moderate-to-severe ...

6.

investors.xencor.com

investors.xencor.com/news-releases/news-release-details/xencors-il2-fc-cytokine-xmabr564-well-tolerated-and-selectively

Xencor's IL2-Fc Cytokine, XmAb®564, is Well-tolerated and ...

Xencor is conducting a randomized, double-blind, placebo-controlled, multiple-ascending dose Phase 1b clinical study to evaluate the safety and ...