New shot shows promise for tough eczema in early trial
NCT ID NCT05549947
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a new drug called SHR-1819 in 158 adults with moderate to severe atopic dermatitis (a type of eczema). Participants received one of three doses of the drug or a placebo. The main goal was to see if the drug could reduce eczema severity by at least 75% after 16 weeks. The trial is now complete, and results will help decide if larger studies are needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1819 injection
- What this could lead to
- If successful, this could lead to a new treatment option for people with moderate to severe atopic dermatitis, helping to control skin inflammation and itching.
- What could go wrong
- This is an early Phase 2 trial with only 158 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
158 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
-
Nov 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol; 2. Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender; 3. Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening; 4. At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%; 5. The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥ 4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected); 6. According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening. Exclusion Criteria: 1. Pregnant or lactating women; 2. Major surgeries are planned for the duration of the study; 3. History of previous atopic corneal conjunctivitis involving the cornea; 4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis; 5. Subjects have had or are currently clinically significant diseases or abnormalities; 6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening; 7. The drug has been used in the previous 6 months; 8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma); 9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation; 10. Any cause that the researchers believe would prevent the participants from participating in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Moderate-to-severe atopic dermatitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Huashan Sub-Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new injection calm severe eczema?
- Can a new injection quiet the itch of severe eczema?
- Can a new pill tame tough eczema? a large trial aims to find out
- New shot could tame tough eczema by calming overactive immune cells
- New drug aims to calm severe eczema without steroids
- New drug shows promise for severe eczema in toddlers