What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, such as dupilumab, tacrolimus, and pimecrolimus, have known side effects. Dupilumab, a monoclonal antibody, can cause injection site reactions, conjunctivitis, and an increased risk of infections. Tacrolimus and pimecrolimus, which are topical immunomodulators, may cause burning or stinging sensations at the application site, skin thinning, and a potential increased risk of skin infections. These treatments aim to reduce T-cell activation and inflammation, similar to the mechanism of Anti-OX40L Monoclonal Antibody (KY1005).

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that target T-cell activation and inflammation. Dupilumab, an IL-4/IL-13 inhibitor, is a monoclonal antibody that reduces inflammation by blocking key cytokines involved in the immune response. Tralokinumab, another monoclonal antibody, targets IL-13 specifically to reduce inflammation. Both treatments are similar to Anti-OX40L Monoclonal Antibody (KY1005) in their approach to modulating the immune system to manage atopic dermatitis.

What other types of research exist?

Promising alternatives for atopic dermatitis treatment in 2024 include Dupilumab, a monoclonal antibody targeting IL-4Rα to inhibit IL-4 and IL-13 signaling, and Tralokinumab, which targets IL-13. Both have demonstrated significant efficacy and safety in clinical trials. Additionally, Lebrikizumab, another IL-13 inhibitor, is also showing potential in ongoing studies.

← Back to Search

Monoclonal Antibodies

KY1005 for Atopic Dermatitis (STREAM-AD Trial)

Phase 2

Waitlist Available

Research Sponsored by Kymab Limited

Eligibility Criteria Checklist

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

Must have

Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.

Baseline worst/maximum pruritus NRS of ≥4.

Must not have

Weight <40 kg or >150 kg at Baseline.

Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at days 15, 29, 57, 85, 113, 141 and 169

Summary

This trial is testing a new medicine called Anti-OX40L Monoclonal Antibody (KY1005) in adults with moderate to severe eczema. The medicine works by blocking a protein that causes inflammation, aiming to reduce symptoms like redness and itching. The study will last for over a year.

Who is the study for?

Adults aged 18-75 with moderate to severe atopic dermatitis (eczema) for over a year, who haven't responded well to topical treatments. They must have an Eczema Area and Severity Index (EASI) score of ≥16, involve ≥10% body surface area, and experience significant itchiness. Excluded are those with certain health conditions or treatments that could interfere with the study.

What is being tested?

The STREAM-AD Study is testing KY1005, an Anti-OX40L Monoclonal Antibody against a placebo in adults with eczema. It's a Phase IIb trial where participants are randomly assigned to different treatment groups without knowing which one they're in and followed up for about 477 days.

What are the potential side effects?

Potential side effects of KY1005 aren't specified here but may include reactions typical of monoclonal antibodies such as infusion-related reactions, immune system changes leading to increased risk of infections or inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 74 years old and have had atopic dermatitis for over a year.

Select...

I have severe itching rated 4 or higher on a scale.

Select...

My skin condition affects 10% or more of my body.

Exclusion Criteria

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

Select...

My weight is either below 40 kg or above 150 kg.

Select...

I am not using birth control and am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at days 15, 29, 57, 85, 113, 141 and 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at days 15, 29, 57, 85, 113, 141 and 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 15, 29, 57, 85, 113, 141 and 169 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage change in EASI (Eczema Area and Severity Index) from Baseline

Secondary study objectives

Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline

Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline

Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline

+18 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: KY1005 Dose Level 4Experimental Treatment1 Intervention

Every 4 weeks

Group II: KY1005 Dose Level 3Experimental Treatment1 Intervention

Every 4 weeks

Group III: KY1005 Dose Level 2Experimental Treatment1 Intervention

Every 4 weeks

Group IV: KY1005 Dose Level 1Experimental Treatment1 Intervention

Every 4 weeks

Group V: PlaceboPlacebo Group1 Intervention

Every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KY1005

2021

Completed Phase 2

~570

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

Common treatments for Atopic Dermatitis (AD) often target immune pathways to reduce inflammation and T-cell activation. For instance, Anti-OX40L Monoclonal Antibody (KY1005) inhibits OX40L, reducing T-cell activation and inflammation. Similarly, dupilumab blocks IL-4 and IL-13 signaling, while JAK inhibitors like baricitinib interfere with the JAK-STAT pathway to decrease cytokine signaling. Topical calcineurin inhibitors such as tacrolimus inhibit T-cell activation by blocking calcineurin. These treatments are essential for AD patients as they address the immune dysregulation that causes chronic inflammation and pruritus, improving overall disease management and quality of life.

Matrine Regulates Th1/Th2 Balance to Treat Eczema by Upregulating Interferon-γ.