Adolescents With Moderate-to-severe Atopic DermatitisPhase 3NCT07309055
A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
A Phase 3 study testing SHR-1819 Injection in people with Adolescents 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 adolescents with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescents With Moderate-to-severe Atopic Dermatitis
- What is being tested?
- SHR-1819 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 2 sitesChina
- Study dates
- 21 Mar 2026to Dec 2027
- Phase
- Phase 3
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female ≥12 to ≤17 years of age at time of screening visit, body weight ≥30kg;
- Diagnosis of Atopic Dermatitis (AD) at least 6 months prior to the screening visit according to the American Academy of Dermatology consensus criteria (Eichenfield 2014);
- Diagnosis of moderate to severe AD at the screening visit and baseline visits meet all of the following 3 criteria simultaneously: EASI ≥16, IGA ≥3, BSA≥10%;
- Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 (A minimum of 5 daily scores out of the 7 days is required to calculate the baseline average score);
- With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable (eg, intolerance, because of important side effects or safety risks). Patients with documented systemic treatment (systemic immunosuppressant drugs like cyclosporine, methotrexate, corticosteroids etc.) for AD in the past 6 months are also considered as inadequate responders to topical treatments;
- Has applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit;
- Participants and their parents/legal guardians voluntarily sign the informed consent form prior to the initiation of any study-related procedures, are able to communicate smoothly with the investigators, and understand and agree to strictly comply with the requirements of this clinical study protocol to complete the study.
Who cannot join
- Has other active skin diseases (e.g., psoriasis or systemic lupus erythematosus) that may affect AD assessment, or skin complications caused by other diseases at screening visit;
- Has a history of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC) within 6 months prior to screening visit;
- Has received any of the following medications within 1 week prior to randomization: a) Topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI); b) Topical traditional Chinese medicine (TCM) for atopic dermatitis; c) Other topical medications with therapeutic effects on AD (including but not limited to topical phosphodiesterase-4 [PDE-4] inhibitors, topical JAK inhibitors, etc.); d) Emollients containing active ingredients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products); e) Leukotriene inhibitors (Note: If the participant is not taking such medications orally at randomization, they must have been off oral administration for at least 1 week prior to randomization; if the participant is taking such medications orally at randomization, they must have received stable-dose treatment for ≥2 weeks prior to randomization and continue stable use throughout the study period);
- Has received ≥2 bleach baths within 2 weeks prior to randomization;
- Has received any of the following treatments within 4 weeks prior to randomization: a) systemic glucocorticoids, immunosuppressants (including but not limited to cyclosporine, azathioprine, methotrexate, etc.), or JAK inhibitors; b) Systemic traditional Chinese medicine (TCM) for atopic dermatitis (including but not limited to Tripterygium Glycosides Tablets, Compound Glycyrrhizin Tablets, etc.); c) Phototherapy (including but not limited to narrowband ultraviolet B [NB-UVB] and ultraviolet A1 [UVA1]) or regular use of tanning booths/room;
- Has received investigational drugs or medical devices within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer;
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- Has used biological products (including but not limited to anti-IL-4Rα monoclonal antibodies, anti-IgE monoclonal antibodies, anti-TSLP monoclonal antibodies, etc.) within 10 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer;
- Has received or been exposed to other live vaccines or attenuated live vaccines within 3 months prior to randomization, or participated in a vaccine clinical trial within 3 months prior to the first dose;
- Has received any cell-depleting agents (including but not limited to rituximab) within 6 months prior to randomization;
- Has received allergen-specific immunotherapy within 6 months prior to randomization;
- Has a current malignant tumor or history of malignant tumor at screening;
- Has undergone major surgery within 3 months prior to the first dose before randomization, or plans to undergo major surgery during the study period;
- Has severe comorbid diseases or other conditions deemed inappropriate for participation in the study by the investigator, including but not limited to endocrine diseases;
- Has been diagnosed with or deemed by the investigator to have suspected immunosuppressive diseases within 6 months prior to screening, including but not limited to non-tuberculous mycobacterial infection, history of opportunistic infections;
- Has a history of infection treated with systemic antimicrobials (for viral, bacterial, fungal, or parasitic infections) within 2 weeks prior to randomization, or has superficial skin infections (e.g., impetigo);
- Has a history of recurrent herpes zoster or Kaposi varicelliform eruption (≥ 2 episodes), disseminated herpes zoster, or disseminated herpes simplex within 1 year prior to screening;
- Suspected or confirmed active tuberculosis (TB);
- Positive results for human immunodeficiency virus (HIV) antibody, syphilis antibody, or hepatitis C virus (HCV) antibody;
- Presence of any of the following abnormalities in laboratory tests (including but not limited to HGB\WBC\Neutrophil\ALT\AST\T-BIL\eGFR) and/or 12-lead electrocardiogram (ECG) within 4 weeks prior to randomization;
- Known hypersensitivity to the study drug or any of its components.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Zhirong Yao, +86-021-25076428, zryaoxh@sina.com
Zhirong Yao
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Xinghua Gao, +86-13940152467, gaobarry@hotmail.com
Xinghua Gao
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adolescents with moderate-to-severe atopic dermatitis.
- Being tested
- SHR-1819 Injection, SHR-1819 Injection Placebo
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 PlaceboDrug
SHR-1819 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental | Dose 1. Receives: Drug: SHR-1819 Injection |
| SHR-1819 Injection Placebo Group with Dose 1 | Placebo comparator | Dose 1. Receives: Drug: SHR-1819 Injection Placebo |
| SHR-1819 Injection Group with Dose 2 | Experimental | Dose 2. Receives: Drug: SHR-1819 Injection |
| SHR-1819 Injection Placebo Group with Dose 2 | Placebo comparator | Dose 2. Receives: Drug: SHR-1819 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Eczema Area and Severity (EASI)-75.
EASI-75: ≥ 75% improvement from baseline.
Measured: At week 16.
Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1.
On a 5-point scale.
Measured: At week 16.
Secondary outcomes (14)
Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline to week 16.
Measured: From baseline up to week 16.
Proportion of patients with Eczema Area and Severity (EASI)-90.
EASI-90: ≥ 90% improvement from baseline.
Measured: At week 16.
Proportion of participants achieving EASI-75 at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Proportion of participants with an IGA score of 0 or 1.
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Proportion of patients with an Investigator's Global Assessment (IGA) score of a ≥ 2-point reduction from baseline.
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
The time from baseline to first achievement of EASI-75 by Week 16.
Measured: By Week 16.
The time from baseline to first achievement of EASI-50 by Week 16.
Measured: By Week 16.
The time from baseline to first achievement of EASI-90 by Week 16.
Measured: By Week 16.
Proportion of participants achieving EASI-50 at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Proportion of participants achieving EASI-90 at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in atopic dermatitis (AD)-affected body surface area (BSA) from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in Children's Dermatology Life Quality Index (CDLQI) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in Patient-Oriented Eczema Measure (POEM) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Proportion of participants with a ≥ 2-point reduction in Investigator's Global Assessment (IGA) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Measured: at week 1, 2, 4, 8, 12, 20, then every 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start21 Mar 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents With 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
- 201 participants (estimated)
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
- NCT07309055
- Sponsor's protocol ID
- SHR-1819-305
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07309055
- Acronym / sponsor ID
- SHR-1819-305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (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 adolescents 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
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental | Drug: SHR-1819 InjectionDose 1. |
| SHR-1819 Injection Placebo Group with Dose 1 | Placebo comparator | Drug: SHR-1819 Injection PlaceboDose 1. |
| SHR-1819 Injection Group with Dose 2 | Experimental | Drug: SHR-1819 InjectionDose 2. |
| SHR-1819 Injection Placebo Group with Dose 2 | Placebo comparator | Drug: SHR-1819 Injection PlaceboDose 2. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female ≥12 to ≤17 years of age at time of screening visit, body weight ≥30kg;
- Diagnosis of Atopic Dermatitis (AD) at least 6 months prior to the screening visit according to the American Academy of Dermatology consensus criteria (Eichenfield 2014);
- Diagnosis of moderate to severe AD at the screening visit and baseline visits meet all of the following 3 criteria simultaneously: EASI ≥16, IGA ≥3, BSA≥10%;
- Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 (A minimum of 5 daily scores out of the 7 days is required to calculate the baseline average score);
- With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable (eg, intolerance, because of important side effects or safety risks). Patients with documented systemic treatment (systemic immunosuppressant drugs like cyclosporine, methotrexate, corticosteroids etc.) for AD in the past 6 months are also considered as inadequate responders to topical treatments;
Key exclusion criteria (20 listed)
- Has other active skin diseases (e.g., psoriasis or systemic lupus erythematosus) that may affect AD assessment, or skin complications caused by other diseases at screening visit;
- Has a history of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC) within 6 months prior to screening visit;
- Has received any of the following medications within 1 week prior to randomization: a) Topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI); b) Topical traditional Chinese medicine (TCM) for atopic dermatitis; c) Other topical medications with therapeutic effects on AD (including but not limited to topical phosphodiesterase-4 [PDE-4] inhibitors, topical JAK inhibitors, etc.); d) Emollients containing active ingredients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products); e) Leukotriene inhibitors (Note: If the participant is not taking such medications orally at randomization, they must have been off oral administration for at least 1 week prior to randomization; if the participant is taking such medications orally at randomization, they must have received stable-dose treatment for ≥2 weeks prior to randomization and continue stable use throughout the study period);
- Has received ≥2 bleach baths within 2 weeks prior to randomization;
- Has received any of the following treatments within 4 weeks prior to randomization: a) systemic glucocorticoids, immunosuppressants (including but not limited to cyclosporine, azathioprine, methotrexate, etc.), or JAK inhibitors; b) Systemic traditional Chinese medicine (TCM) for atopic dermatitis (including but not limited to Tripterygium Glycosides Tablets, Compound Glycyrrhizin Tablets, etc.); c) Phototherapy (including but not limited to narrowband ultraviolet B [NB-UVB] and ultraviolet A1 [UVA1]) or regular use of tanning booths/room;
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 PlaceboSHR-1819 injection placebo. | Drug | SHR-1819 Injection Placebo Group with Dose 1, SHR-1819 Injection Placebo Group with Dose 2 |
Primary outcome
Proportion of patients with Eczema Area and Severity (EASI)-75.
Time frame: At week 16.
EASI-75: ≥ 75% improvement from baseline.
Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1.
Time frame: At week 16.
On a 5-point scale.
14 secondary outcomes
Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline to week 16.
Time frame: From baseline up to week 16.
Proportion of patients with Eczema Area and Severity (EASI)-90.
Time frame: At week 16.
Proportion of participants achieving EASI-75 at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Proportion of participants with an IGA score of 0 or 1.
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Proportion of patients with an Investigator's Global Assessment (IGA) score of a ≥ 2-point reduction from baseline.
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
The time from baseline to first achievement of EASI-75 by Week 16.
Time frame: By Week 16.
The time from baseline to first achievement of EASI-50 by Week 16.
Time frame: By Week 16.
The time from baseline to first achievement of EASI-90 by Week 16.
Time frame: By Week 16.
Proportion of participants achieving EASI-50 at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Proportion of participants achieving EASI-90 at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in atopic dermatitis (AD)-affected body surface area (BSA) from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in Children's Dermatology Life Quality Index (CDLQI) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Change and percentage change in Patient-Oriented Eczema Measure (POEM) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Proportion of participants with a ≥ 2-point reduction in Investigator's Global Assessment (IGA) score from baseline at week 1, 2, 4, 8, 12, 20, then every 4 weeks
Time frame: at week 1, 2, 4, 8, 12, 20, then every 4 week
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 8 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1819 Injection in people with Adolescents 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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 8 Sep 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Xiaoyan Bai (+86-0518-82342973, xiaoyan.bai.xb1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Eczema Area and Severity (EASI)-75. (time frame: At week 16.). The study lists 2 primary outcomes in all. 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 8 Sep 2026.