Atopic DermatitisPhase 2NCT07330934
A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Dupilumab and IBI356 in people with Atopic Dermatitis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab and IBI356
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 18 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign the informed consent form (ICF);
- Aged ≥ 18 years, male or female;
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
- EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
- Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.
Who cannot join
- Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.
- Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- Has known or suspected helminth or other parasitic infection.
- History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
- History of severe drug allergy or anaphylaxis.
- Fainting, hemophobia, or inability to tolerate venipuncture.
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- Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.
- Have received an organ or hematopoietic stem cell transplant.
- Positive HBsAg; or positive HBcAb with positive HBV-DNA; or positive hepatitis C antibody with positive HCV-RNA; or positive treponema pallidum antibody; or positive HIV serology at screening.
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab, Placebo, IBI356
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Dupilumab by subcutaneous injection
PlaceboDrug
Placebo by subcutaneous injection
IBI356Drug
IBI356 by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBI356 dose 4 | Experimental | Participants receive IBI356 through W16 Receives: Drug: IBI356 |
| IBI356 dose 2 | Experimental | Participants receive IBI356 through W16 Receives: Drug: IBI356 |
| Dupilumab | Experimental | Participants receive dupilumab through W16 Receives: Drug: Dupilumab |
| IBI356 dose 5 | Experimental | Participants receive IBI356 through W16 Receives: Drug: IBI356 |
| IBI356 dose 1 | Experimental | Participants receive IBI356 through W16 Receives: Drug: IBI356 |
| Placebo | Placebo comparator | Participants receive placebo through W16 Receives: Drug: Placebo |
| IBI356 dose 3 | Experimental | Participants receive IBI356 through W16 Receives: Drug: IBI356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in Eczema Area and Severity Index (EASI) score
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Measured: week 24
Secondary outcomes (10)
Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction
The vIGA-AD is sn investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Measured: week 16, 24
Proportion of participants with EASI-75/90/100
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Measured: week16, 24
Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS)
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Measured: week 16, 24
Change in EASI from baseline
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Measured: Baseline to Week 48
Change in DLQI from baseline
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Measured: Baseline to Week 48
Change in POEM from baseline
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Measured: Baseline to Week 48
Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)
Measured: Baseline to Week 48
Serum IBI356 concentrations at prespecified timepoints
Measured: Baseline to Week 24
Percentage of Participants with Treatment-emergent ADA of IBI356
Measured: Baseline to Week 24
Serum IL-13 (PD marker) be assessed as dose-dependent drug responses
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start31 Dec 2025
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330934
- Sponsor's protocol ID
- CIBI356A201
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07330934
- Acronym / sponsor ID
- CIBI356A201
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 9 Jan 2026 (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 is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IBI356 dose 4 | Experimental | Drug: IBI356Participants receive IBI356 through W16 |
| IBI356 dose 2 | Experimental | Drug: IBI356Participants receive IBI356 through W16 |
| Dupilumab | Experimental | Drug: DupilumabParticipants receive dupilumab through W16 |
| IBI356 dose 5 | Experimental | Drug: IBI356Participants receive IBI356 through W16 |
| IBI356 dose 1 | Experimental | Drug: IBI356Participants receive IBI356 through W16 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo through W16 |
| IBI356 dose 3 | Experimental | Drug: IBI356Participants receive IBI356 through W16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and sign the informed consent form (ICF);
- Aged ≥ 18 years, male or female;
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
- EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
- Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.
Key exclusion criteria (11 listed)
- Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.
- Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- Has known or suspected helminth or other parasitic infection.
- History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
- History of severe drug allergy or anaphylaxis.
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 |
|---|---|---|
| DupilumabDupilumab by subcutaneous injection | Drug | Dupilumab |
| PlaceboPlacebo by subcutaneous injection | Drug | Placebo |
| IBI356IBI356 by subcutaneous injection | Drug | IBI356 dose 1, IBI356 dose 2, IBI356 dose 3, IBI356 dose 4, IBI356 dose 5 |
Primary outcome
Percent change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: week 24
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
10 secondary outcomes
Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction
Time frame: week 16, 24
Proportion of participants with EASI-75/90/100
Time frame: week16, 24
Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS)
Time frame: week 16, 24
Change in EASI from baseline
Time frame: Baseline to Week 48
Change in DLQI from baseline
Time frame: Baseline to Week 48
Change in POEM from baseline
Time frame: Baseline to Week 48
Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)
Time frame: Baseline to Week 48
Serum IBI356 concentrations at prespecified timepoints
Time frame: Baseline to Week 24
Percentage of Participants with Treatment-emergent ADA of IBI356
Time frame: Baseline to Week 24
Serum IL-13 (PD marker) be assessed as dose-dependent drug responses
Time frame: Baseline to Week 48
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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 2 study testing Dupilumab and IBI356 in people with Atopic Dermatitis, run by Innovent Biologics (Suzhou) 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Oct 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Percent change from baseline in Eczema Area and Severity Index (EASI) score (time frame: week 24). 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 27 Oct 2026.