Children and Adolescents With Moderate-to-severe Atopic DermatitisPhase 1/2NCT06713499
A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
A Phase 1/2 study testing SHR-1819 injection in people with Children and 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 safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Children and 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?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2024to 22 Nov 2025
- Phase
- Phase 1/2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects and their parents or legal guardians 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 investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;
- Have atopic dermatitis at screening.
Who cannot join
- Before enrollment, the subjects weighed < 15kg;
- Females who are pregnant or lactating and have a positive pregnancy test result;
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
- Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
- Has malignancy or has a history of malignancy;
- Hypersensitivity to the study drug or any ingredient in the study drug.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
About this study
Official title: A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with 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.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 injection | Experimental | Dose 1, dose 2 and dose 3. Receives: Drug: SHR-1819 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Up to 14 weeks.
Heart rate
Measured: Up to 14 weeks.
PR interval
Measured: Up to 14 weeks.
QT interval
Measured: Up to 14 weeks.
QRS duration
Measured: Up to 14 weeks.
Secondary outcomes (3)
The concentration of SHR-1819 in serum
Measured: From the beginning of administration to the 14th week.
Changes in the level of TARC/CCL17 in the serum
Changes in the level of biomarkers in serum.
Measured: From the beginning of administration to the 14th week.
Evaluate the incidence and timing of ADA positivity for SHR-1819
Changes in the level of immunogenicity in the body.
Measured: From the beginning of administration to the 14th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start18 Dec 2024
- Primary completion22 Nov 2025
- Study completion22 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children and Adolescents With 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT06713499
- Sponsor's protocol ID
- SHR-1819-204
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2024
- Last updated
- 2 Jul 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06713499
- Acronym / sponsor ID
- SHR-1819-204
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 22 Nov 2025 (actual)
- First posted
- 3 Dec 2024 (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 safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
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 injectionDose 1, dose 2 and dose 3. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects and their parents or legal guardians 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 investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;
- Have atopic dermatitis at screening.
Key exclusion criteria (7 listed)
- Before enrollment, the subjects weighed < 15kg;
- Females who are pregnant or lactating and have a positive pregnancy test result;
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
- Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
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 |
Primary outcome
Adverse events
Time frame: Up to 14 weeks.
Heart rate
Time frame: Up to 14 weeks.
PR interval
Time frame: Up to 14 weeks.
QT interval
Time frame: Up to 14 weeks.
QRS duration
Time frame: Up to 14 weeks.
3 secondary outcomes
The concentration of SHR-1819 in serum
Time frame: From the beginning of administration to the 14th week.
Changes in the level of TARC/CCL17 in the serum
Time frame: From the beginning of administration to the 14th week.
Evaluate the incidence and timing of ADA positivity for SHR-1819
Time frame: From the beginning of administration to the 14th 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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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 1/2 study testing SHR-1819 injection in people with Children and 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 3 inclusion and 7 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 2 Jul 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 combined 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.
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?
Adverse events (time frame: Up to 14 weeks.). The study lists 5 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 2 Jul 2026.