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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
For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 15, 29, 57, 85, 113, 141 and 169
Awards & highlights

STREAM-AD Trial Summary

This trial is studying the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.

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.Check my eligibility
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.See study design
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.

STREAM-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to provide skin biopsies for the sub-study.
Select...
I am between 18 and 74 years old and have had atopic dermatitis for over a year.
Select...
Topical treatments haven't worked for me in the last 6 months.
Select...
I have severe itching rated 4 or higher on a scale.
Select...
My skin condition affects 10% or more of my body.
Select...
I have used a simple moisturizer twice daily for at least 7 days.

STREAM-AD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage change in EASI (Eczema Area and Severity Index) from Baseline
Secondary outcome measures
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
+22 more

STREAM-AD 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
2017
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

Kymab LimitedLead Sponsor
4 Previous Clinical Trials
457 Total Patients Enrolled
SanofiIndustry Sponsor
2,161 Previous Clinical Trials
3,511,649 Total Patients Enrolled

Media Library

KY1005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05131477 — Phase 2
Atopic Dermatitis Research Study Groups: Placebo, KY1005 Dose Level 1, KY1005 Dose Level 4, KY1005 Dose Level 2, KY1005 Dose Level 3
Atopic Dermatitis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still looking for volunteers?

"That is correct, the online information indicates that this study is looking for volunteers. The trial was first posted on March 2nd, 2022 and has been updated October 18th, 2022. They are hoping to find 350 individuals willing to participate at 32 different centres."

Answered by AI

Is this research study only for people over the age of 65?

"According to the inclusion criteria found on clinicaltrials.gov, patients must be aged 18-75 to participate in this trial. There are 111 trials for patients under the age of 18 and 180 for people over 65."

Answered by AI

Are there many research facilities administering this trial throughout North America?

"To make the trial as accessible as possible for patients, it is being run out of 32 sites which are located in various cities including Louisville, Rochester and Sacramento. Before signing up, be sure to check if there is a location near you to reduce travel burdens."

Answered by AI

How many people have signed up for this clinical trial?

"350 patients that fall within the set parameters are required for this experiment. The study will be carried out in multiple locations by sponsor Sanofi, with two sites being Investigative Site: 1021 in Louisville, Kentucky and Investigative Site: 1020 in Rochester, New york."

Answered by AI

What are the potential side-effects of KY1005?

"KY1005's safety was ranked a 2 because, while there is data indicating that it is safe, there is no information yet on whether or not the drug is effective."

Answered by AI

Who meets the eligibility requirements for participation in this clinical trial?

"This study is enrolling 350 participants, aged 18-75, who have eczema. Patients must also meet the following criteria: Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline., 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., EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline., IGA"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
2021. "Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05131477.
~117 spots leftby Apr 2025
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