← Back to Search

Immunosuppressant

Core Treatment Active Experimental: SHR0302 Dose#2 for Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Reistone Biopharma Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a diagnosis of atopic dermatitis for at least 1 year.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all scheduled visits from week 16 24 - 56
Awards & highlights

Study Summary

This trial will test if a new drug is effective and safe for people with moderate to severe atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with atopic dermatitis for at least one year.
Select...
You must stop using certain medications for eczema for a period of time before starting the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all scheduled visits from week 16 24 - 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and all scheduled visits from week 16 24 - 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Eczema Area and Severity Index (EASI 75) at Week 16
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Secondary outcome measures
EASI 75 at Week 1, 4, 8 and 12
IGA 0/1 at Week 1, 4, 8 and 12
Time to WI-NRS response
+2 more
Other outcome measures
Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Immunoglobulin E
+9 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension Treatment Active Experimental: SHR0302 Dose#2Experimental Treatment1 Intervention
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Group II: Extension Treatment Active Experimental: SHR0302 Dose#1Experimental Treatment1 Intervention
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Group III: Core Treatment Active Experimental: SHR0302 Dose#2Experimental Treatment1 Intervention
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Group IV: Core Treatment Active Experimental: SHR0302 Dose#1Experimental Treatment1 Intervention
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Group V: Core Treatment Placebo Comparator: PlaceboPlacebo Group1 Intervention
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extension Treatment Active Experimental: SHR0302 Dose#1
2021
Completed Phase 3
~340
Core Treatment Active Experimental: SHR0302 Dose#2
2021
Completed Phase 3
~340
Extension Treatment Active Experimental: SHR0302 Dose#2
2021
Completed Phase 3
~340
Core Treatment Active Experimental: SHR0302 Dose#1
2021
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Reistone Biopharma Company LimitedLead Sponsor
10 Previous Clinical Trials
1,964 Total Patients Enrolled

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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 ."

Answered by AI

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"

Answered by AI
~88 spots leftby Mar 2025