What side effects are associated with this type of intervention?

Common treatments for psoriasis, particularly biologics and immunomodulatory agents, have several known side effects. TNF-alpha inhibitors (e.g., etanercept, adalimumab, infliximab) can increase the risk of infections, injection-site reactions, and potentially squamous cell carcinoma. IL-12/23 inhibitors like ustekinumab have been associated with concerns about cardiovascular risks, although meta-analyses have not confirmed a significant increase. IL-17 inhibitors (e.g., secukinumab, ixekizumab) may lead to inflammatory bowel disease events. Overall, while these treatments are effective, they require careful monitoring for adverse effects.

What prior FDA approvals exist?

Several biologic agents and systemic treatments have been approved by the FDA for the treatment of moderate to severe plaque psoriasis. These include TNF-alpha inhibitors such as etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol, which reduce inflammation by targeting tumor necrosis factor-alpha. Additionally, IL-12/23 inhibitors like ustekinumab and IL-23 inhibitors such as risankizumab have been approved for their immunomodulatory effects. IL-17 inhibitors, including secukinumab and ixekizumab, and IL-4/IL-13 dual blockade with dupilumab, are also used to manage psoriasis by targeting specific interleukins involved in the inflammatory process.

What other types of research exist?

Promising novel alternatives to KBL697 for psoriasis treatment in 2024 include: <ol> <li>Secukinumab: An IL-17A inhibitor with demonstrated efficacy in moderate to severe psoriasis and psoriatic arthritis.</li> <li></li> </ol> Ixekizumab: Another IL-17A inhibitor showing favorable safety and efficacy profiles. 3. Brodalumab: Targets IL-17 receptor and has shown significant improvement in psoriasis symptoms. 4. Ustekinumab: Targets IL-12 and IL-23, effective in both skin and nail psoriasis. 5. Certolizumab Pegol: A TNF inhibitor with proven benefits in nail psoriasis and psoriatic arthritis. 6. Golimumab: A TNF inhibitor with demonstrated efficacy in psoriatic arthritis and nail psoriasis.

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KBL697 for Psoriasis

Phase 2

Waitlist Available

Led By Jennifer Soung

Research Sponsored by KoBioLabs

Eligibility Criteria Checklist

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

Must have

Must have chronic plaque type psoriasis of moderate severity

Male or female, aged 18 to 75 years (inclusive)

Must not have

Failed 2 or more systemic treatments for plaque psoriasis

Drug-induced psoriasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called KBL697 to see if it can help people with moderate plaque psoriasis. The study focuses on patients who may not respond well to current treatments. KBL697 aims to reduce symptoms like redness and scaling.

Who is the study for?

This trial is for men and women aged 18-75 with chronic moderate plaque type psoriasis, diagnosed at least 6 months ago. Participants must commit to using reliable contraception. It's not for those with drug-induced psoriasis, other skin diseases that could affect results, or who failed two or more systemic treatments.

What is being tested?

The study tests the effectiveness and safety of a new potential treatment called KBL697 specifically developed for Moderate Plaque Type Psoriasis. The goal is to see how well it works compared to existing treatments.

What are the potential side effects?

While specific side effects of KBL697 are not listed here, common side effects in psoriasis treatments may include skin irritation, headaches, fatigue, nausea and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have long-term moderate plaque psoriasis.

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I am between 18 and 75 years old.

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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 have tried at least 2 treatments for plaque psoriasis without success.

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My psoriasis was caused by medication.

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My psoriasis is not the chronic plaque type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 4, 8 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 4, 8 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Physician's Global Assessment (PGA)

Psoriasis Area and Severity Index (PASI)

Psoriasis Area and Severity Index (PASI) -50

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low dose groupExperimental Treatment1 Intervention

39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.

Group II: High dose groupExperimental Treatment1 Intervention

39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KBL697

2019

Completed Phase 1

~40

0 / 6Eligibility 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

Common treatments for psoriasis, particularly those similar to KBL697, include TNF-alpha inhibitors, IL-12/23 inhibitors, and other biologic agents, as well as oral therapies like methotrexate and cyclosporine. These treatments work by targeting specific immune pathways that are overactive in psoriasis. TNF-alpha inhibitors, for example, block the tumor necrosis factor-alpha protein, reducing inflammation and immune response. IL-12/23 inhibitors target interleukins involved in the inflammatory process. Methotrexate and cyclosporine suppress the overall immune system to reduce skin cell turnover. These mechanisms are crucial for psoriasis patients as they help manage symptoms, reduce flare-ups, and improve quality of life by controlling the underlying immune dysfunction.

TNFalpha blockade in human diseases: mechanisms and future directions.