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Core Treatment Active Experimental: SHR0302 Dose#2 for Atopic Dermatitis
Study Summary
This trial will test if a new drug is effective and safe for people with moderate to severe atopic dermatitis.
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there any available positions for patients in this clinical trial?
"The study, which as of 10/31/2022 is still recruiting patients, was first posted on 4/30/2021."
Do elderly individuals fit the age demographic for this research project?
"This clinical trial is seeking patients that fall between the ages of 12 and 75. There are a total of 111 studies for people under 18 and 181 trials for patients over 65 years old."
What is the FDA's decision on Core Treatment Active Experimental: SHR0302 Dose#2?
"Core Treatment Active Experimental: SHR0302 Dose#2 is believed to be safe, as it has received a score of 3. This is due to the fact that this Phase 3 trial has data supporting its efficacy and multiple rounds of data affirming its safety."
How many individuals are being given this therapy as part of the research?
"That is correct, the information available on clinicaltrials.gov does say that this trial is still recruiting patients. This trial was first posted on 4/30/2021 and has been edited as recently as 10/31/2022. They are looking for a total of 336 patients from 1 site."
What are the goals that investigators hope to achieve with this experiment?
"Per the study sponsor, Reistone Biopharma Company Limited, the primary outcome will be determined by measuring Eczema Area and Severity Index (EASI 75) over a 16-week period. Additionally, this trial will evaluate secondary outcomes including IGA 0/1 at Week 1, 4, 8 and 12 , Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12 , and Worst-Itch Numeric Rating Scale (WI-NRS)-4 at Week 16 ."
Who meets the qualifications to participate in this clinical trial?
"This medical study is looking for 336 participants with eczema aged 12 to 75. To be eligible, patients must meet the following criteria: Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg, Subject has a diagnosis of atopic dermatitis for at least 1 year., Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4, Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period"
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