XmAb27564 for Psoriasis

Recruiting at 7 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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug XmAb27564 for treating psoriasis?

Research shows that targeting interleukin-23, a part of the immune system, can improve psoriasis symptoms. Drugs like tildrakizumab and guselkumab, which also target interleukin-23, have been effective in reducing psoriasis severity, suggesting that XmAb27564 might work similarly. ^{1 2 3 4 5}

What makes the drug XmAb27564 unique for treating psoriasis?

The drug XmAb27564 is unique for treating psoriasis as it likely targets specific immune pathways involved in the disease, similar to other treatments that focus on interleukin (IL) pathways, such as IL-23 and IL-17, which are known to play a significant role in psoriasis. This targeted approach can potentially offer more effective and tailored treatment options compared to traditional therapies. ^{2 6 7 8 9}

Research Team

Ralph Zitnik, MD

Principal Investigator

Executive Medical Director, Clinical Development, Xencor, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinical improvement in psoriasis with specific targeting of interleukin-23. [2019]

3. England 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). [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ixekizumab treatment for psoriasis: integrated efficacy analysis of three double-blinded, controlled studies (UNCOVER-1, UNCOVER-2, UNCOVER-3). [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Systemic therapies for psoriasis: understanding current and newly emerging therapies. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Generation and functional characterization of anti-human and anti-mouse IL-36R antagonist monoclonal antibodies. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Pathophysiology of moderate to severe plaque psoriasis: anti-IL-17 towards disease modification. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Psoriasis: pathological mechanisms, current pharmacological therapies, and emerging drug delivery systems. [2021]