Moderate to Severe Atopic DermatitisPhase 3NCT06468956
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
A Phase 3 study testing SHR-1819 in people with Moderate to Severe Atopic Dermatitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- SHR-1819
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2024to 26 Aug 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
- The age was ≥18 at the time of signing the informed consent and gender is unlimited;
- Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
- EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
- TCS was not optimal or not tolerated by the investigator.
Who cannot join
- Pregnant or lactating women;
- Major surgeries are planned for the duration of the study;
- History of previous atopic corneal conjunctivitis involving the cornea;
- 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;
- Subjects have had or are currently clinically significant diseases or abnormalities;
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
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- The drug has been used in the previous 6 months;
- 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);
- Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
- Any cause that the researchers believe would prevent the participants from participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Patients With Moderate to Severe Atopic Dermatitis
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- SHR-1819, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819Drug
SHR-1819 injection
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 injection dose 1 | Experimental | Not described Receives: Drug: SHR-1819 |
| SHR-1819 injection dose 2 | Experimental | Not described Receives: Drug: SHR-1819 |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)
The extent of area is assessed using the EASI scale
Measured: up to 16 weeks
At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 and a decrease of ≥2 points from baseline
The overall degree of improvement was assessed using the IGA scale
Measured: up to 16 week
Secondary outcomes (12)
The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16
Prtch improvement was assessed using the pruritus scale
Measured: up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline)
The extent of area is assessed using the EASI scale
Measured: up to 16 weeks
Proportion of subjects reaching EASI-75 at other visit viewpoints
The extent of area is assessed using the EASI scale
Measured: up to 52 weeks
The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline
The overall degree of improvement was assessed using the IGA scale
Measured: up to 52 weeks
Proproportion of subjects with a 2 points from baseline at each iGA
The overall degree of improvement was assessed using the IGA scale
Measured: up to 52 weeks
Percentage of change and change from baseline in EASI per visit viewpoint
The extent of area is assessed using the EASI scale
Measured: up to 52 weeks
Percentage of subjects with weekly mean PP-NRS scores of 3 points from baseline
Prtch improvement was assessed using the pruritus scale
Measured: up to 52 weeks
Percentage of change and change from baseline in the Skin Quality of Life Index Questionnaire (DLQI) score at each visit viewpoint
Subject quality of life was assessed using the DLQI scale
Measured: From the beginning of administration to the 52 week
Percentage of change from baseline in eczema self-assessment (POEM) scores at each viewpoint
Subject quality of life was assessed using the POEM scale
Measured: From the beginning of administration to the 52 week
The time of SHR-1819 in the serum
The concentration of SHR-1819 in plasma will be determined
Measured: From the beginning of administration to the 52th week
The concentration of SHR-1819 in serum: AUC
The concentration of SHR-1819 in plasma will be determined
Measured: From the beginning of administration to the 52th week
Changes in the level of IgE in the serum
Changes in the level of biomarkers in serum
Measured: From the beginning of administration to the 52th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start14 Jun 2024
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468956
- Sponsor's protocol ID
- SHR-1819-301
- Status last verified
- Sep 2025
- First submitted
- 24 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided