Moderate to Severe Atopic DermatitisPhase 2NCT06012812
A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing SHR-1819 injection in people with Moderate to Severe Atopic Dermatitis, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2023to 5 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- The age of 18~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited；
- Previous atopic dermatitis, (1) participation in a complete main study; or (2) subjects who prematurely terminate primary study therapy for reasons other than SHR-1819 injection are required to complete a last safety follow-up or withdrawal from the visit, and the investigator assesses that the influencing factor has been eliminated/no longer affects the participant's participation in the extended study. Participants were required to meet the main study inclusion criteria for the main study；
- Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study;
- Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.
Who cannot join
- Pregnant or lactating women；
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements;
- A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
- Hypersensitivity to the study drug or any ingredient in the study drug；
- Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
- Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose；
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- Suspected or confirmed active tuberculosis (TB);
- Have malignancy or history of malignancy prior to screening；
- Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study；
- There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial;
- There were treatment-related adverse events leading to discontinuation of treatment and study drug-related SAEs in the main study, and the investigator or sponsor medical department considered that continuing to participate in extended therapy would pose an unacceptable safety risk to participants.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis
This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- SHR-1819 injection
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 300 mg Q2W
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 injection | Experimental | Not described Receives: Drug: SHR-1819 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs) (per person-year)
Measured: Up to 60 weeks
Secondary outcomes (8)
Serious Adverse Event (SAE) during treatment (per person-year)
Measured: Up to 60 weeks
Adverse Events of Special Interest (AESI) during treatment (per person-year)
Measured: Up to 60 weeks
Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
Measured: Up to 60 weeks
Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
Measured: Up to 60 weeks
Proportion of participants with at least 1 remission in this study
Measured: Up to 60 weeks
Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)
Measured: Up to 60 weeks
The concentration of SHR-1819 in serum :Cmax
Measured: From the beginning of administration to the 60h week
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Measured: From the beginning of administration to the 60th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start6 Sep 2023
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
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 Shanghai Hengrui Pharmaceutical Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012812
- Sponsor's protocol ID
- SHR-1819-203
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2023
- Last updated
- 5 Mar 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06012812
- Acronym / sponsor ID
- SHR-1819-203
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 28 Aug 2023 (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 study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 injection | Experimental | Drug: SHR-1819 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The age of 18~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited；
- Previous atopic dermatitis, (1) participation in a complete main study; or (2) subjects who prematurely terminate primary study therapy for reasons other than SHR-1819 injection are required to complete a last safety follow-up or withdrawal from the visit, and the investigator assesses that the influencing factor has been eliminated/no longer affects the participant's participation in the extended study. Participants were required to meet the main study inclusion criteria for the main study；
- Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study;
- Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.
Key exclusion criteria (11 listed)
- Pregnant or lactating women；
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements;
- A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
- Hypersensitivity to the study drug or any ingredient in the study drug；
- Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
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 300 mg Q2W | Drug | SHR-1819 injection |
Primary outcome
Treatment Emergent Adverse Events (TEAEs) (per person-year)
Time frame: Up to 60 weeks
8 secondary outcomes
Serious Adverse Event (SAE) during treatment (per person-year)
Time frame: Up to 60 weeks
Adverse Events of Special Interest (AESI) during treatment (per person-year)
Time frame: Up to 60 weeks
Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
Time frame: Up to 60 weeks
Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
Time frame: Up to 60 weeks
Proportion of participants with at least 1 remission in this study
Time frame: Up to 60 weeks
Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)
Time frame: Up to 60 weeks
The concentration of SHR-1819 in serum :Cmax
Time frame: From the beginning of administration to the 60h week
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Time frame: From the beginning of administration to the 60th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
1 site 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 in people with Moderate to Severe Atopic Dermatitis, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Emergent Adverse Events (TEAEs) (per person-year) (time frame: Up to 60 weeks). 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 5 Mar 2026.