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KY1005 for Atopic Dermatitis (STREAM-AD Trial)
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.
STREAM-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTREAM-AD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STREAM-AD Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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