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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
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I am between 18 and 74 years old and have had atopic dermatitis for over a year.
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I have severe itching rated 4 or higher on a scale.
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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:
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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 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

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-<i>γ</i>.

Find a Location

Who is running the clinical trial?

Kymab LimitedLead Sponsor
4 Previous Clinical Trials
399 Total Patients Enrolled
SanofiIndustry Sponsor
2,197 Previous Clinical Trials
4,034,923 Total Patients Enrolled
42 Trials studying Eczema
15,548 Patients Enrolled for Eczema

Media Library

KY1005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05131477 — Phase 2
Eczema Research Study Groups: Placebo, KY1005 Dose Level 1, KY1005 Dose Level 4, KY1005 Dose Level 2, KY1005 Dose Level 3
Eczema Clinical Trial 2023: KY1005 Highlights & Side Effects. Trial Name: NCT05131477 — Phase 2
KY1005 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131477 — Phase 2
~102 spots leftby Nov 2025