Moderate to Severe Atopic DermatitisPhase 2NCT05549947

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

A Phase 2 study testing SHR-1819 in people with Moderate to Severe Atopic Dermatitis, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 158 participants
Where: 1 siteChina
Study dates: 8 Oct 2022to 23 Nov 2023
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

Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol;
Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%;
The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥ 4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);
According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening.

Who cannot join

Pregnant or lactating women;
Major surgeries are planned for the duration of the study;
History of previous atopic corneal conjunctivitis involving the cornea;
History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
Subjects have had or are currently clinically significant diseases or abnormalities;
Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;

Show all 10Show fewer

The drug has been used in the previous 6 months;
Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
Any cause that the researchers believe would prevent the participants from participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Sub-Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.

Conditions: Moderate to Severe Atopic Dermatitis
Being tested: SHR-1819, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-1819Drug
Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.
PlaceboDrug
Treatment group D: placebo

Study groups in NCT05549947
Study group	Role	What they receive
Treatment group A: SHR-1819	Experimental	Not described Receives: Drug: SHR-1819
Treatment group B: SHR-1819	Experimental	Not described Receives: Drug: SHR-1819
Treatment group C: SHR-1819	Experimental	Not described Receives: Drug: SHR-1819
Treatment group D: placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)
EASI sore use EASI scale
Measured: Up to 16 weeks

Secondary outcomes (15)

At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline
The overall degree of improvement was assessed using the IGA scale
Measured: Up to 16 weeks
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points
The overall degree of improvement was assessed using the IGA scale
Measured: Up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)
The extent of area is assessed using the EASI scale
Measured: Up to 16 weeks
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)
The extent of area is assessed using the EASI scale
Measured: Up to 16 weeks
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points
The extent of pruritus is assessed using the P-NRS scale
Measured: Up to 16 weeks
At week 16, EASI is the percentage change from baseline and change
The extent of area is assessed using the EASI scale
Measured: Up to 16 weeks
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
The extent of lesions and pruritus is assessed using the SCORAD scale
Measured: Up to 16 weeks
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
The BSA scale was used to assess improvement in lesion area
Measured: Up to 16 weeks
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change
The quality of Life is assessed using the DLQI scale
Measured: Up to 16 weeks
The incidence of adverse events ranged from the first dose to 24 weeks
Assess the post-medication safety of subjects from the first dose to the time they exit the group
Measured: From the beginning of administration to the 24th week
Concentration of SHR-1819 in serum
Measured: From the beginning of administration to the 24th week
Changes of TARC/CCL17 in the serum
Measured: From the beginning of administration to the 24th week
Changes of IgE in the serum
Measured: From the beginning of administration to the 24th week
Changes of eotaxin-3 in the serum
Measured: From the beginning of administration to the 24th week
Immunogenicity of SHR-1819
Measured: From the beginning of administration to the 24th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202223 Nov 2023

First posted22 Sep 2022
Study start8 Oct 2022
Primary completion15 Sep 2023
Study completion23 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05549947
Sponsor's protocol ID: SHR-1819-201
Status last verified: Apr 2026
First submitted: 19 Sep 2022
Last updated: 29 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Gu C, Yin H, Yang B, Ji S, Bian K, Man X, Lu J, Sui D, Zhou Y, Cheng F, Xu A, Li X, Jiang M, Diao Q, Ji C, Shi T, Ding Y, Ren H, Li Y, Liu H, Meng Z, Feng P, Zhang S, Bai X, Li P, Dong Y, Liu S, Zhang C, Xu J. Anti-IL-4Ralpha antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study. BMC Med. 2026 May 28. doi: 10.1186/s12916-026-04952-3. Online ahead of print.
PubMed 42210243

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic

All Moderate to Severe Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT05549947
Acronym / sponsor ID: SHR-1819-201
Conditions: Moderate to Severe Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Oct 2022 (actual)
Primary completion: 15 Sep 2023 (actual)
Study completion: 23 Nov 2023 (actual)
First posted: 22 Sep 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.

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Treatment group A: SHR-1819	Experimental	Drug: SHR-1819
Treatment group B: SHR-1819	Experimental	Drug: SHR-1819
Treatment group C: SHR-1819	Experimental	Drug: SHR-1819
Treatment group D: placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol;
Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%;
The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥ 4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);

Key exclusion criteria (10 listed)

Pregnant or lactating women;
Major surgeries are planned for the duration of the study;
History of previous atopic corneal conjunctivitis involving the cornea;
History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
Subjects have had or are currently clinically significant diseases or abnormalities;

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-1819Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C：SHR-1819 injection dose 3.	Drug	Treatment group A: SHR-1819, Treatment group B: SHR-1819, Treatment group C: SHR-1819
PlaceboTreatment group D: placebo	Drug	Treatment group D: placebo

Primary outcome

At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)
Time frame: Up to 16 weeks
EASI sore use EASI scale

15 secondary outcomes

At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline
Time frame: Up to 16 weeks
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points
Time frame: Up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)
Time frame: Up to 16 weeks
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)
Time frame: Up to 16 weeks
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points
Time frame: Up to 16 weeks
At week 16, EASI is the percentage change from baseline and change
Time frame: Up to 16 weeks
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
Time frame: Up to 16 weeks
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
Time frame: Up to 16 weeks
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change
Time frame: Up to 16 weeks
The incidence of adverse events ranged from the first dose to 24 weeks
Time frame: From the beginning of administration to the 24th week
Concentration of SHR-1819 in serum
Time frame: From the beginning of administration to the 24th week
Changes of TARC/CCL17 in the serum
Time frame: From the beginning of administration to the 24th week
Changes of IgE in the serum
Time frame: From the beginning of administration to the 24th week
Changes of eotaxin-3 in the serum
Time frame: From the beginning of administration to the 24th week
Immunogenicity of SHR-1819
Time frame: From the beginning of administration to the 24th 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 29 Apr 2026.
Derived from this study: PubMed 42210243Gu C, Yin H, Yang B, Ji S, Bian K, Man X, Lu J, Sui D, Zhou Y, Cheng F, Xu A, Li X, Jiang M, Diao Q, Ji C, Shi T, Ding Y, Ren H, Li Y, Liu H, Meng Z, Feng P, Zhang S, Bai X, Li P, Dong Y, Liu S, Zhang C, Xu J. Anti-IL-4Ralpha antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study. BMC Med. 2026 May 28. doi: 10.1186/s12916-026-04952-3. Online ahead of print.
Individual participant dataSharing planned: Undecided

Related trials for Moderate to Severe Atopic Dermatitis

Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic

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 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 6 inclusion and 10 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 29 Apr 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 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?

At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline) (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05549947, which also lists 1 linked publication.

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 29 Apr 2026.