A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis
NCT ID: NCT07015762
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2025-07-14
2026-05-20
Brief Summary
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The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort.
Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo 4ml SC
Participants with AD will receive Placebo 4ml SC
Placebo
Participants with AD will receive placebo at the corresponding volume and dosing interval.
IBI3002 300mg SC
Participants with AD will receive IBI3002 300mg SC
IBI3002
Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.
IBI3002 600mg SC
Participants with AD will receive IBI3002 600mg SC
IBI3002
Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.
Placebo 2ml SC
Participants with AD will receive Placebo 2ml SC
Placebo
Participants with AD will receive placebo at the corresponding volume and dosing interval.
Placebo 1ml SC
Participants with AD will receive Placebo 1ml SC
Placebo
Participants with AD will receive placebo at the corresponding volume and dosing interval.
IBI3002 150mg SC
Participants with AD will receive IBI3002 150mg SC
IBI3002
Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.
Interventions
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IBI3002
Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.
Placebo
Participants with AD will receive placebo at the corresponding volume and dosing interval.
Eligibility Criteria
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Inclusion Criteria
2. Weight ≥40kg.
3. Meet the diagnostic criteria of the Hannifin \& Rajka criteria, and have been diagnosed with AD for ≥12 months at screening. If determined by Investigators, previous diagnostic terms like "dermatitis" and "eczema" are also acceptable.
4. Have an Eczema area and severity index (EASI) score ≥16, the Investigator´s Global Assessment score ≥3, and the involved Body Surface Area (BSA) ≥10% at screening and randomization.
Exclusion Criteria
2. Participants with a known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis; Or there is any other clinical evidence of latent tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first dose until the end of the study. If the participant is judged by Investigator to be intolerant to preventive anti-tuberculosis treatment, they should not be included in the study either.
3. A history of malignant tumors, except for resected or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
4. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value, at screening or randomization.
5. The co-existing of any other skin comorbidities that may interfere with the assessment related to AD, in the opinion of Investigators.
The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
18 Years
65 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI3002T002
Identifier Type: -
Identifier Source: org_study_id
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