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NCT Number: NCT07015762

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis

This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002.

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Naihui Zhou

CONTACT

[email protected]

13328008259

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 65 years.
  • Weight ≥40kg.
  • 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.
  • 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

  • Having any disease that have an impact on the participant's own safety or participation in the study. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system, in the opinion of Investigator.
  • 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.
  • A history of malignant tumors, except for resected or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
  • The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value, at screening or randomization.
  • 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.

Treatment and study plan

IBI3002

Drug

Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.

Placebo

Drug

Participants with AD will receive placebo at the corresponding volume and dosing interval.

Primary outcomes

  1. To evaluate the safety and tolerability of multiple doses of IBI3002 in Atopic Dermatitis patients.

    Time frame: Baseline to Week 20

    The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with AD after multiple doses of IBI3002;

Secondary outcomes

  1. To evaluate the PK parameters of IBI3002 in participants with AD;

    Time frame: Baseline to Week 20

    PK parameters include, the maximum concentration (Cmax), after multiple doses.

  2. To evaluate the PK parameters of IBI3002 in participants with AD;

    Time frame: Baseline to Week 20

    PK parameters include, the maximum concentration (Tmax), after multiple doses.

  3. To evaluate the PK parameters of IBI3002 in participants with AD;

    Time frame: Baseline to Week 20

    PK parameters include, the maximum concentration (AUC), after multiple doses.

Study contacts

Contact information is provided by the study sponsor or research team.

Wensheng Zang

CONTACT

[email protected]

15210342569

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Registry information

Official study title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis - a Randomized, Double-Blind, Placebo-Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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