Atopic DermatitisPhase 2NCT07399067
A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing IBI3002 and Dupilumab in people with Atopic Dermatitis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- IBI3002 and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2026to 27 May 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
- Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
- Age between 18 and 75 years old (inclusive).
- Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
- Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.
- At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.
- At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4.
- History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).
Who cannot join
- Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.
- Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
- History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
- Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.
- Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.
Show all 10Show fewer
- Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.
- Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period.
- Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.
- History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries/regions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.
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
China-japan Friendship Hospital
Beijing, Beijing Municipality, 100192
Yong Cui, +8615701625913, wuhucuiyong@vip263.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof-of-Concept Study to Evaluate the Efficacy and Safety of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamic (PD) effects of IBI3002 in Chinese participants with moderate-to-severe AD.
A total of approximately 120 participants with moderate-to-severe AD are planned for enrollment. Intensive blood collection, categorized as yes or no, and baseline disease severity, categorized as moderate (vIGA-AD = 3) or severe (vIGA-AD = 4), will be used as a stratification factor. Eligible participants will be randomized to six treatment groups in a 2:1:1:2:2:2 ratio, including multiple dose levels of IBI3002, dupilumab, and matched placebo administered subcutaneously at specified intervals.
The study will assess changes in clinical efficacy measures, PK parameters, immunogenicity, and PD biomarkers over the treatment period.
- Conditions
- Atopic Dermatitis
- Being tested
- IBI3002, Placebo, Dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3002Drug
IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
PlaceboDrug
Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
DupilumabDrug
Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| IBI3002 Dose Level 2 with Dosing Interval 2 | Experimental | Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule. Receives: Drug: IBI3002; Drug: Placebo |
| Placebo | Placebo comparator | Matched placebo will be administered subcutaneously according to the study schedule. Receives: Drug: Placebo |
| IBI3002 Dose Level 3 with Dosing Interval 2 | Experimental | Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule. Receives: Drug: IBI3002 |
| IBI3002 Dose Level 1 with Dosing Interval 1 | Experimental | Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule. Receives: Drug: IBI3002; Drug: Placebo |
| IBI3002 Dose Level 1 with Dosing Interval 2 | Experimental | Participants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule. Receives: Drug: IBI3002; Drug: Placebo |
| Dupilumab | Active comparator | Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg. Receives: Drug: Placebo; Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
Percentage change from baseline in the EASI score at Week 16 in participants with moderate to severe AD after administration of IBI3002. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease.
EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Measured: Week 16
Secondary outcomes (13)
Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Percentage of participants who have experienced AEs/SAEs.
Measured: Up to 20 weeks
Pharmacokinetic parameter Cmax of IBI3002 following multiple doses
Maximum observed concentration (Cmax) of IBI3002 following multiple doses.
Measured: Up to 20 weeks
Pharmacokinetic parameter Tmax of IBI3002 following multiple doses
Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses.
Measured: Up to 20 weeks
Pharmacokinetic parameter AUC of IBI3002 following multiple doses
Area under the concentration-time curve (AUC) of IBI3002 following multiple doses.
Measured: Up to 20 weeks
Immunogenicity of IBI3002 following multiple doses
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs) in participants receiving IBI3002.
Measured: Up to 20 weeks
Percentage of participants with a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost Clear) and a reduction ≥ 2 points from baseline at Week 16
The vIGA-AD is a 5-point scale used to assess the overall severity of AD based on key acute clinical signs, including erythema, induration/papulation, oozing/crusting (lichenification excluded). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static assessment performed independently of previous scores and is conducted prior to the EASI assessment.
Measured: Week 16
Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16
Proportion of patients with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease.
EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Measured: Week 16
Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16
Proportion of patients with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease.
EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Measured: Week 16
Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16
Proportion of patients with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease.
EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Measured: Week 16
Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16
Proportion of patients with a 100% improvement from baseline in EASI (EASI-100) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease.
EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Measured: Week 16
Proportion of participants achieving vIGA-AD 0 or 1 at Week 16
The vIGA-AD is a 5-point scale assessing overall disease severity based on key acute clinical signs. Scores range from 0 (clear) to 4 (severe). The proportion of participants with a score of 0 (clear) or 1 (almost clear) will be assessed at Week 16.
Measured: Week 16
Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16
The vIGA-AD is a 5-point scale assessing overall disease severity based on key acute clinical signs. Scores range from 0 (clear) to 4 (severe). The proportion of participants achieving a ≥2-point reduction from baseline will be assessed at Week 16.
Measured: Week 16
Proportion of participants with ≥4-point reduction from baseline in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) during at Week 16
The PP-NRS is a patient-reported tool used to assess the intensity of pruritus (itch) over a 24-hour recall period. Participants rate their worst itch on an 11-point scale from 0 (no itch) to 10 (worst itch imaginable) by answering: "On a scale of 0 to 10, how would you rate your worst itch during the previous 24 hours?" Higher scores indicate greater itch severity. At least 4 daily scores out of 7 days are required to calculate the weekly average score.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Feb 2026
- Primary completion23 Mar 2027 (estimated)
- Study completion27 May 2027 (estimated)
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
- 120 participants (estimated)
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
- NCT07399067
- Sponsor's protocol ID
- CIBI3002B201
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 13 Feb 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof-of-Concept Study to Evaluate the Efficacy and Safety of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07399067
- Acronym / sponsor ID
- CIBI3002B201
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 10 Feb 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.
The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamic (PD) effects of IBI3002 in Chinese participants with moderate-to-severe AD.
A total of approximately 120 participants with moderate-to-severe AD are planned for enrollment. Intensive blood collection, categorized as yes or no, and baseline disease severity, categorized as moderate (vIGA-AD = 3) or severe (vIGA-AD = 4), will be used as a stratification factor. Eligible participants will be randomized to six treatment groups in a 2:1:1:2:2:2 ratio, including multiple dose levels of IBI3002, dupilumab, and matched placebo administered subcutaneously at specified intervals.
The study will assess changes in clinical efficacy measures, PK parameters, immunogenicity, and PD biomarkers over the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IBI3002 Dose Level 2 with Dosing Interval 2 | Experimental | Drug: IBI3002, Drug: PlaceboParticipants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule. |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo will be administered subcutaneously according to the study schedule. |
| IBI3002 Dose Level 3 with Dosing Interval 2 | Experimental | Drug: IBI3002Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule. |
| IBI3002 Dose Level 1 with Dosing Interval 1 | Experimental | Drug: IBI3002, Drug: PlaceboParticipants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule. |
| IBI3002 Dose Level 1 with Dosing Interval 2 | Experimental | Drug: IBI3002, Drug: PlaceboParticipants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule. |
| Dupilumab | Active comparator | Drug: Placebo, Drug: DupilumabParticipants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
- Age between 18 and 75 years old (inclusive).
- Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
- Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.
- At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.
Key exclusion criteria (10 listed)
- Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.
- Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
- History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
- History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
- Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.
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 |
|---|---|---|
| IBI3002IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval. | Drug | IBI3002 Dose Level 1 with Dosing Interval 1, IBI3002 Dose Level 1 with Dosing Interval 2, IBI3002 Dose Level 2 with Dosing Interval 2, IBI3002 Dose Level 3 with Dosing Interval 2 |
| PlaceboMatched placebo will be administered subcutaneously at the same schedule as IBI3002. | Drug | Dupilumab, IBI3002 Dose Level 1 with Dosing Interval 1, IBI3002 Dose Level 1 with Dosing Interval 2, IBI3002 Dose Level 2 with Dosing Interval 2, Placebo |
| DupilumabDupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously. | Drug | Dupilumab |
Primary outcome
Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
Time frame: Week 16
Percentage change from baseline in the EASI score at Week 16 in participants with moderate to severe AD after administration of IBI3002. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
13 secondary outcomes
Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Up to 20 weeks
Pharmacokinetic parameter Cmax of IBI3002 following multiple doses
Time frame: Up to 20 weeks
Pharmacokinetic parameter Tmax of IBI3002 following multiple doses
Time frame: Up to 20 weeks
Pharmacokinetic parameter AUC of IBI3002 following multiple doses
Time frame: Up to 20 weeks
Immunogenicity of IBI3002 following multiple doses
Time frame: Up to 20 weeks
Percentage of participants with a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost Clear) and a reduction ≥ 2 points from baseline at Week 16
Time frame: Week 16
Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16
Time frame: Week 16
Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16
Time frame: Week 16
Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16
Time frame: Week 16
Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16
Time frame: Week 16
Proportion of participants achieving vIGA-AD 0 or 1 at Week 16
Time frame: Week 16
Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16
Time frame: Week 16
Proportion of participants with ≥4-point reduction from baseline in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) during at Week 16
Time frame: Week 16
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 13 Feb 2026.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, 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
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 IBI3002 and Dupilumab 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 7 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: looking for participants now, as of the sponsor's last update on 13 Feb 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 Man Yang (+8618907163461, man.yang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 (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 13 Feb 2026.