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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 belowSelect...
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
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 moreTrial 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>.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with HIV, hepatitis B, or hepatitis C.I have not received a live vaccine in the last 12 weeks.I have used treatments for my skin condition before the study starts.I do not have severe illnesses like heart failure or kidney disease that would stop me from joining the study.I have a history of weak immunity with frequent or severe infections.I am willing to provide skin biopsies for the sub-study.My weight is either below 40 kg or above 150 kg.I am not using birth control and am not pregnant or breastfeeding.I have no cancer history except for treated skin cancer or cervical cancer.I am between 18 and 74 years old and have had atopic dermatitis for over a year.Your IGA score is 3 or 4 at the beginning of the study.Your skin condition is very severe, with a score of 12 or higher at the Screening Visit and 16 or higher at Baseline.Topical treatments haven't worked for me in the last 6 months.I have severe itching rated 4 or higher on a scale.My skin condition affects 10% or more of my body.I have used a simple moisturizer twice daily for at least 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: KY1005 Dose Level 1
- Group 3: KY1005 Dose Level 4
- Group 4: KY1005 Dose Level 2
- Group 5: KY1005 Dose Level 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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