What is the mechanism of action of this treatment?

Psoriasis treatments often target specific inflammatory pathways to reduce symptoms and prevent disease progression. Monoclonal antibodies, such as those targeting TNF-alpha (e.g., infliximab, adalimumab) and interleukins like IL-12/23 (e.g., ustekinumab) and IL-17 (e.g., secukinumab), work by inhibiting key cytokines involved in the inflammatory process. These treatments help decrease the overactive immune response that causes the rapid skin cell turnover and inflammation characteristic of psoriasis. Understanding these mechanisms is crucial for patients, as it highlights the importance of targeted therapies in managing their condition effectively and minimizing potential side effects.

What side effects are associated with this type of intervention?

Common treatments for moderate-to-severe psoriasis, such as TNF-alpha inhibitors (e.g., etanercept, infliximab, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-17 inhibitors (e.g., secukinumab, ixekizumab), are generally effective but come with potential side effects. These can include increased risk of infections, injection site reactions, and potential cardiovascular events. Long-term use may also be associated with a higher risk of malignancies and autoimmune conditions. Monitoring and regular follow-up with a healthcare provider are essential to manage these risks.

What prior FDA approvals exist?

Several monoclonal antibodies targeting inflammatory pathways have been approved by the FDA for the treatment of moderate-to-severe psoriasis. These include TNF-alpha inhibitors like etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol. IL-12/23 inhibitors such as ustekinumab have also been approved, as well as IL-17 inhibitors like secukinumab and ixekizumab. These biologic agents work by targeting specific components of the immune system to reduce inflammation and plaque formation in psoriasis patients.

What other types of research exist?

Promising novel alternatives to BMS-986322 for psoriasis treatment include: 1) Vunakizumab (SHR-1314), an interleukin 17A monoclonal antibody, which has shown efficacy and tolerability in phase II trials. 2) Risankizumab, an anti-IL-23p19 antibody, which has demonstrated significant efficacy and safety in phase III trials. 3) Briakinumab, an anti-IL-12/23p40 monoclonal antibody, which has shown effectiveness in phase III studies. These alternatives have shown promising results in clinical trials and could be considered for treatment in 2024.

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Monoclonal Antibodies

BMS-986322 for Psoriasis

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Psoriatic plaques must cover ≥ 10% of body surface area at baseline

Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs)

Must not have

Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment

Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called BMS-986322 to see if it can help people with moderate-to-severe psoriasis by reducing inflammation and slowing down skin cell growth.

Who is the study for?

This trial is for adults who've had plaque psoriasis for at least 6 months, with a moderate to severe level of disease. They should be eligible for phototherapy or systemic therapy and have plaques covering 10% or more of their body. People with certain other immune conditions, significant illnesses, or non-plaque forms of psoriasis cannot join.

What is being tested?

The study tests the effectiveness and safety of BMS-986322 compared to a placebo in treating moderate-to-severe psoriasis. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with treatments like BMS-986322 may include skin reactions at injection sites, infections due to lowered immunity, headaches, fatigue, and possible liver issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

My psoriasis covers 10% or more of my body.

Select...

My BMI is between 18 and 40, and I weigh more than 50 kg (110 lbs).

Select...

I have been diagnosed with plaque psoriasis for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on immune-suppressing medication for a condition like uveitis, IBD, or related to PsO.

Select...

I have been diagnosed with a type of psoriasis that is not plaque psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BMS-986322 Dose 3Experimental Treatment1 Intervention

Group II: BMS-986322 Dose 2Experimental Treatment1 Intervention

Group III: BMS-986322 Dose 1Experimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986322

2022

Completed Phase 2

~430

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriasis treatments often target specific inflammatory pathways to reduce symptoms and prevent disease progression. Monoclonal antibodies, such as those targeting TNF-alpha (e.g., infliximab, adalimumab) and interleukins like IL-12/23 (e.g., ustekinumab) and IL-17 (e.g., secukinumab), work by inhibiting key cytokines involved in the inflammatory process. These treatments help decrease the overactive immune response that causes the rapid skin cell turnover and inflammation characteristic of psoriasis. Understanding these mechanisms is crucial for patients, as it highlights the importance of targeted therapies in managing their condition effectively and minimizing potential side effects.