Moderate-to-severe Atopic DermatitisPhase 2NCT07321951
A Study of SHR-1819 in Patients With Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing SHR-1819 Injection and SHR-1819 Injection Blank Preparation in people with Moderate-to-severe Atopic Dermatitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe 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 Injection and SHR-1819 Injection Blank Preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 2 sitesChina
- Study dates
- 9 Jan 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
- The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
- Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
- Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
- Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.
Who cannot join
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
- Has malignancy or has a history of malignancy.
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- Hypersensitivity to the study drug or any ingredient in the study drug.
- Females who are pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- SHR-1819 Injection, SHR-1819 Injection Blank Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819 InjectionDrug
SHR-1819 injection.
SHR-1819 Injection Blank PreparationDrug
SHR-1819 injection blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental | Not described Receives: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Blank Preparation |
| SHR-1819 Injection Group with Dose 2 | Experimental | Not described Receives: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Blank Preparation |
| SHR-1819 Injection Group with Dose 3 | Experimental | Not described Receives: Drug: SHR-1819 Injection; Drug: SHR-1819 Injection Blank Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).
Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.
Measured: Week 24.
Secondary outcomes (3)
The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.
The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale.
Measured: Week 24.
Adverse events (AEs).
Measured: About 42 weeks.
The concentration of SHR-1819 in serum.
Measured: From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start9 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 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
- NCT07321951
- Sponsor's protocol ID
- SHR-1819-207
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07321951
- Acronym / sponsor ID
- SHR-1819-207
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental | Drug: SHR-1819 Injection, Drug: SHR-1819 Injection Blank Preparation |
| SHR-1819 Injection Group with Dose 2 | Experimental | Drug: SHR-1819 Injection, Drug: SHR-1819 Injection Blank Preparation |
| SHR-1819 Injection Group with Dose 3 | Experimental | Drug: SHR-1819 Injection, Drug: SHR-1819 Injection Blank Preparation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At the time of signing the informed consent, the subjects are ≥18 years old and ≤75 years old, male or female.
- The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
- Topical emollients are applied at a stable dose twice daily for at least 7 days before the first dose in the run-in phase and continued for the duration of the study.
- Have atopic dermatitis at the time of screening and have an investigator-assessed history of atopic dermatitis for at least 1 year before screening.
- Have moderate to severe atopic dermatitis during the screening period and on the day of the first dose.
Key exclusion criteria (6 listed)
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- A history of spring keratoconjunctivitis and/or atopic keratoconjunctivitis within 6 months prior to screening.
- Has malignancy or has a history of malignancy.
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- Hypersensitivity to the study drug or any ingredient in the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1819 InjectionSHR-1819 injection. | Drug | SHR-1819 Injection Group with Dose 1, SHR-1819 Injection Group with Dose 2, SHR-1819 Injection Group with Dose 3 |
| SHR-1819 Injection Blank PreparationSHR-1819 injection blank preparation. | Drug | SHR-1819 Injection Group with Dose 1, SHR-1819 Injection Group with Dose 2, SHR-1819 Injection Group with Dose 3 |
Primary outcome
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).
Time frame: Week 24.
Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.
3 secondary outcomes
The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.
Time frame: Week 24.
Adverse events (AEs).
Time frame: About 42 weeks.
The concentration of SHR-1819 in serum.
Time frame: From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1819 Injection and SHR-1819 Injection Blank Preparation in people with Moderate-to-severe Atopic Dermatitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline). (time frame: Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.