Moderate-to-severe Atopic DermatitisPhase 2NCT07211542
A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing SHR-1905 Injection and SHR-1905 Injection Blank Preparation in people with Moderate-to-severe Atopic Dermatitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe 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-1905 Injection and SHR-1905 Injection Blank Preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2025to Feb 2027
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects 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 researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
- At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
- Have atopic dermatitis at screening.
Who cannot join
- Hypersensitivity to the study drug or any ingredient in the study drug.
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- Has malignancy or has a history of malignancy.
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Bin Yang, +86-13922207231, yangbin101@hotmail.com
Bin Yang
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis
This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- SHR-1905 Injection, SHR-1905 Injection Blank Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1905 InjectionDrug
SHR-1905 injection.
SHR-1905 Injection Blank PreparationDrug
SHR-1905 injection blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1905 Injection Group - Dose 1 | Experimental | Dose 1. Receives: Drug: SHR-1905 Injection |
| SHR-1905 Injection Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-1905 Injection Blank Preparation |
| SHR-1905 Injection Group - Dose 2 | Experimental | Dose 2. Receives: Drug: SHR-1905 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.
Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.
Measured: Week 16.
Secondary outcomes (12)
The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.
Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline.
Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.
The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.
The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline.
EASI score using the EASI scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline.
EASI score using the EASI scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline.
EASI score using the EASI scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change value in EASI score from the baseline.
EASI score using the EASI scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in EASI score from the baseline.
EASI score using the EASI scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.
BSA score using the BSA scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.
BSA score using the BSA scale.
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
Adverse events (AEs).
Measured: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start7 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 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
- NCT07211542
- Sponsor's protocol ID
- SHR-1905-205
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 8 Apr 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07211542
- Acronym / sponsor ID
- SHR-1905-205
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Oct 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-1905 in patients 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
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-1905 Injection Group - Dose 1 | Experimental | Drug: SHR-1905 InjectionDose 1. |
| SHR-1905 Injection Placebo Group | Placebo comparator | Drug: SHR-1905 Injection Blank Preparation |
| SHR-1905 Injection Group - Dose 2 | Experimental | Drug: SHR-1905 InjectionDose 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subjects 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 researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.
- At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.
- Have atopic dermatitis at screening.
Key exclusion criteria (5 listed)
- Hypersensitivity to the study drug or any ingredient in the study drug.
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).
- Has malignancy or has a history of malignancy.
- Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.
- Females who are pregnant or lactating.
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-1905 InjectionSHR-1905 injection. | Drug | SHR-1905 Injection Group - Dose 1, SHR-1905 Injection Group - Dose 2 |
| SHR-1905 Injection Blank PreparationSHR-1905 injection blank preparation. | Drug | SHR-1905 Injection Placebo Group |
Primary outcome
The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.
Time frame: Week 16.
Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.
12 secondary outcomes
The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 75% compared to the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 90% compared to the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The proportion of subjects whose EASI score decreased ≥ 50% compared to the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change value in EASI score from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in EASI score from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
The percentage of change in Body Surface Area Involvement of Atopic Dermatitis (BSA) from the baseline.
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
Adverse events (AEs).
Time frame: At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
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 Apr 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.
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-1905 Injection and SHR-1905 Injection Blank Preparation in people with Moderate-to-severe Atopic Dermatitis, run by Guangdong 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 3 inclusion and 5 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 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?
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 Ran Li (+86-0518-82342973, ran.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline. (time frame: Week 16.). 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 Apr 2026.