Moderate to Severe Atopic DermatitisPhase 1NCT05197023
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
A Phase 1 study of Moderate to Severe Atopic Dermatitis, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study will be conducted to evaluate the safety and tolerability of SHR-1819 injection and describe the PK/PD/ADA and explore the clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 27 Oct 2022
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form prior to starting any study-related procedures, be able to communicate with the investigator, understand and be willing to complete this study in strict accordance with the requirements of the study protocol;
- Age ≥ 18 years and ≤ 65 years on the day of signing informed consent form, male or female;
- Have been diagnosed with atopic dermatitis (as per American Academy of Dermatology Criteria[6], 2014) for at least 1 year prior to screening;
- Have moderate to severe atopic dermatitis during screening and baseline periods. Moderate to severe disease is defined as meeting the following 3 conditions at the same time:
- 1) Eczema Area and Severity Index (EASI) score ≥ 12; 2) Investigator's Global Assessment (IGA) score ≥ 3; 3) Body Surface Area Involvement of Atopic Dermatitis (BSA) ≥ 10%; 5. Subjects must meet at least one of the following conditions within 6 months prior to screening, as judged by the investigator:
- Inadequate response to stable treatment with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) for at least 4 weeks;
- Or inadequate response to longest duration of treatment recommended by the prescribing information of a topical medication (such as: 14 days of treatment with super potent TCS);
- Or unsuitable for topical treatment as judged by the investigator (such as intolerable or with contraindications); 6. Have used stable doses of basic, mild, topical emollient (moisturizer) without active ingredients twice daily for at least 7 consecutive days prior to baseline period, and continue to use during the study; 7. Subjects (including their partners) must have no fertility plan and agree to adopt effective contraceptive measures throughout the study (starting from 2 weeks before the first dose for female subjects) until 4 months after the last dose. Male subjects must agree to use a condom during intercourse throughout the study until 4 months after the last dose; female subjects of childbearing potential must have a negative human chorionic gonadotropin (HCG) test result during screening or baseline period, not be breastfeeding, and only be enrolled after confirmation of the last menstruation; female subjects without childbearing potential, the definition of without childbearing potential is: permanent sterilization (such as bilateral oophorectomy, hysterectomy, bilateral salpingectomy) or menopausal women (defined as more than 12 months of amenorrhea without pathological etiology and serum follicle-stimulating hormone (FSH) > 40 IU/L).
Who cannot join
- -
- General conditions:
- Pregnant or lactating women (pregnancy is defined as the state from conception to termination of gestation) or tested positive for human chorionic gonadotropin (HCG);
- Have a history of alcohol abuse or illegal drug abuse within 6 months prior to screening;
- Have conditions that may affect the safety and efficacy evaluations of the investigational product based on the investigator's judgment; 2. Laboratory test results and/or 12-lead ECG findings during the screening or baseline period (tests may be repeated one time for confirmation when necessary):
- 1) Hemoglobin < 100.0 g/L (male) or < 90.0 g/L (female); 2) White blood cell count < 3.0 × 109/L; 3) Neutrophil count < 1.5 × 109/L; 4) Platelet count < 100 × 109/L; 5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); 6) Total bilirubin (T-BIL) > 1.5 × ULN; 7) Serum creatinine > ULN; 8) Positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody (HIV), syphilis antibody, or hepatitis C virus (HCV) antibody; 9) Clinically significant abnormal 12-lead ECG findings that may affect the subject safety, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significant QTc prolongation (QTc > 500 ms).
Show all 34Show fewer
- 3. Have any of the following medical histories or concurrent diseases:
- Allergy to investigational product or any component of the investigational product;
- History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC);
- Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; or abnormally frequent, recurrent, or long-term infection based on the investigator's judgment;
- active chronic active or acute infection requiring systemic treatments such as antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to screening; or superficial skin infection within 1 week prior to screening. Note: A patient may be re-screened (once only) after the infection has resolved;
- Diagnosed with or suspected of active tuberculosis, latent untreated tuberculosis, incompletely treated tuberculosis, or nontuberculous mycobacterial infection based on the investigator and/or infectious disease specialist's judgment (as indicated by medical history, symptoms, signs, laboratory tests, X-ray or CT findings) (except subjects with treatment records demonstrating adequate treatment, who may begin treatment with biological product based on the investigator and/or infectious disease specialist's judgment);
- History of parasite infestation/infection within 6 months prior to screening;
- Prior (within 5 years prior to screening) or current malignant tumors (except for completely resected squamous cell carcinoma of skin, basal cell carcinoma, or cervical carcinoma in situ with no evidence of recurrence);
- Severe, progressive, and uncontrolled cardiovascular, cerebrovascular, hepatic, renal, lung, gastrointestinal, hematopoietic, endocrine, nervous system, and psychiatric disorders, as well as other conditions that are unsuitable for study participation, as judged by the investigator.
- 4. Used any of the following drugs/treatments or participated in a clinical study (defined as having signed informed consent form and received treatment with a drug/medical device at least once): Received treatment with other biological products targeting IL-4Rα or participated in a clinical study involving another biological product targeting IL-4Rα;
- Received treatment with an investigational drug (such as JAK inhibitors) or medical device within 8 weeks or 5 half-lives prior to baseline (whichever is longer);
- Received treatment with systemic corticosteroids or immunosuppressants for atopic dermatitis within 4 weeks prior to baseline;
- Received systemic treatment with Traditional Chinese medicine for atopic dermatitis within 4 weeks prior to baseline;
- Received ultraviolet phototherapy (including but not limited to narrow-band ultraviolet B phototherapy (NB-UVB) and medium- to high-dose UVA1) or regular use of tanning booth/parlor for atopic dermatitis within 4 weeks prior to baseline;
- Used bleach baths ≥ 2 times within 2 weeks prior to baseline;
- Received the following topical medications for atopic dermatitis within 1 week prior to baseline:
- Topical corticosteroids or topical calcineurin inhibitors;
- Topical traditional Chinese medicine;
- Other topical medications (including but not limited to phosphodiesterase 4 (PDE-4) inhibitor);
- Received treatment with the following biological products prior to baseline:
- Any cell depletion therapy, including but not limited to rituximab: within 6 months prior to baseline or until lymphocyte count returns to normal (whichever is longer);
- Other biological products: within 5 half-lives (if the half-life is known) or 16 weeks prior to baseline (whichever is longer);
- Received allergen-specific immunotherapy within 6 weeks prior to baseline;
- Received treatment with leukotriene inhibitors within 4 weeks prior to baseline;
- Started treatment with prescription emollients or emollients containing active ingredients (such as ceramide, hyaluronic acid, urea, or filaggrin breakdown products) during the screening period (patients may continue to use these types of emollients at stable doses if they have already been using them prior to the screening visit);
- Underwent major surgery within 3 months prior to baseline or have not recovered, or plan to undergo major surgery during the course of the study;
- History of blood donation or severe blood loss (total blood loss ≥ 500 mL) within 1 month prior to screening, or received blood transfusion within 2 months prior to screening;
- Received a live attenuated vaccine/live vaccine within 12 weeks prior to baseline, or plan to receive a live attenuated vaccine/live vaccine during the course of the study, or participated in a vaccine clinical trial within 12 weeks prior to baseline.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, DOSE-ESCALATION, PLACEBO-CONTROLLED PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
The study will be conducted to evaluate the safety and tolerability of SHR-1819 injection and describe the PK/PD/ADA and explore the clinical efficacy.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- SHR-1819 injection or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819 injection or placeboDrug
Drug: SHR-1819 injection or placebo Low-dose group, once per week Drug: SHR-1819 injection or placebo High-dose group, once per week
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 injection | Experimental | Not described Receives: Drug: SHR-1819 injection or placebo |
| placebo | Placebo comparator | Not described Receives: Drug: SHR-1819 injection or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline up to end of study (up to Day 85)
Secondary outcomes (10)
Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)
Measured: 1-85 days
Pharmacokinetics of Dupilumab: Area under the plasma concentration versus time curve(AUC)
Measured: 1-85 days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)
Measured: 1-85 days
Pharmacokinetics of Dupilumab: Apparent clearance(CL/F)
Measured: 1-85 days
Pharmacokinetics of Dupilumab: Apparent volume of distributions(VZ/F)
Measured: 1-85 days
Pharmacokinetics of Dupilumab: Trough concentration(Ctrough)
Measured: 1-85 days
Serum TARC level and its percentage change from baseline
Measured: 1-85 days
Serum CCL17 level and its percentage change from baseline
Measured: 1-85 days
Serum immunoglobulin E (IgE) level and its percentage change from baseline
Measured: 1-85 days
Immunogenicity endpoints: anti-SHR-1819 antibody (ADA) positive rate and onset time.
Measured: 1-85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start30 Jan 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR1819 injection dose-escalation in AD patients
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 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
- NCT05197023
- Sponsor's protocol ID
- SHR-1819-103
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2021
- Last updated
- 21 Aug 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, DOSE-ESCALATION, PLACEBO-CONTROLLED PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT05197023
- Acronym / sponsor ID
- SHR-1819-103
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 19 Jan 2022 (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.
The study will be conducted to evaluate the safety and tolerability of SHR-1819 injection and describe the PK/PD/ADA and explore the clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- SHR1819 injection dose-escalation in AD patients
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 injection | Experimental | Drug: SHR-1819 injection or placebo |
| placebo | Placebo comparator | Drug: SHR-1819 injection or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form prior to starting any study-related procedures, be able to communicate with the investigator, understand and be willing to complete this study in strict accordance with the requirements of the study protocol;
- Age ≥ 18 years and ≤ 65 years on the day of signing informed consent form, male or female;
- Have been diagnosed with atopic dermatitis (as per American Academy of Dermatology Criteria[6], 2014) for at least 1 year prior to screening;
- Have moderate to severe atopic dermatitis during screening and baseline periods. Moderate to severe disease is defined as meeting the following 3 conditions at the same time:
- 1) Eczema Area and Severity Index (EASI) score ≥ 12; 2) Investigator's Global Assessment (IGA) score ≥ 3; 3) Body Surface Area Involvement of Atopic Dermatitis (BSA) ≥ 10%; 5. Subjects must meet at least one of the following conditions within 6 months prior to screening, as judged by the investigator:
Key exclusion criteria (34 listed)
- -
- Pregnant or lactating women (pregnancy is defined as the state from conception to termination of gestation) or tested positive for human chorionic gonadotropin (HCG);
- Have a history of alcohol abuse or illegal drug abuse within 6 months prior to screening;
- Have conditions that may affect the safety and efficacy evaluations of the investigational product based on the investigator's judgment; 2. Laboratory test results and/or 12-lead ECG findings during the screening or baseline period (tests may be repeated one time for confirmation when necessary):
- 1) Hemoglobin < 100.0 g/L (male) or < 90.0 g/L (female); 2) White blood cell count < 3.0 × 109/L; 3) Neutrophil count < 1.5 × 109/L; 4) Platelet count < 100 × 109/L; 5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); 6) Total bilirubin (T-BIL) > 1.5 × ULN; 7) Serum creatinine > ULN; 8) Positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody (HIV), syphilis antibody, or hepatitis C virus (HCV) antibody; 9) Clinically significant abnormal 12-lead ECG findings that may affect the subject safety, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significant QTc prolongation (QTc > 500 ms).
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 injection or placeboDrug: SHR-1819 injection or placebo Low-dose group, once per week Drug: SHR-1819 injection or placebo High-dose group, once per week | Drug | SHR-1819 injection, placebo |
Primary outcome
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to end of study (up to Day 85)
10 secondary outcomes
Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)
Time frame: 1-85 days
Pharmacokinetics of Dupilumab: Area under the plasma concentration versus time curve(AUC)
Time frame: 1-85 days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)
Time frame: 1-85 days
Pharmacokinetics of Dupilumab: Apparent clearance(CL/F)
Time frame: 1-85 days
Pharmacokinetics of Dupilumab: Apparent volume of distributions(VZ/F)
Time frame: 1-85 days
Pharmacokinetics of Dupilumab: Trough concentration(Ctrough)
Time frame: 1-85 days
Serum TARC level and its percentage change from baseline
Time frame: 1-85 days
Serum CCL17 level and its percentage change from baseline
Time frame: 1-85 days
Serum immunoglobulin E (IgE) level and its percentage change from baseline
Time frame: 1-85 days
Immunogenicity endpoints: anti-SHR-1819 antibody (ADA) positive rate and onset time.
Time frame: 1-85 days
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 21 Aug 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 1 study of 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 8 inclusion and 34 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 21 Aug 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to end of study (up to Day 85)). 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 21 Aug 2026.