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NCT Number: NCT07399067

A Proof-of-Concept Study 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).

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100192, China

Location status: Recruiting

Location contact

Yong Cui

CONTACT

[email protected]

+8615701625913

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

IBI3002

Drug

IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.

Placebo

Drug

Matched placebo will be administered subcutaneously at the same schedule as IBI3002.

Dupilumab

Drug

Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)

    Time frame: Up to 20 weeks

    Percentage of participants who have experienced AEs/SAEs.

  2. Pharmacokinetic parameter Cmax of IBI3002 following multiple doses

    Time frame: Up to 20 weeks

    Maximum observed concentration (Cmax) of IBI3002 following multiple doses.

  3. Pharmacokinetic parameter Tmax of IBI3002 following multiple doses

    Time frame: Up to 20 weeks

    Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses.

  4. Pharmacokinetic parameter AUC of IBI3002 following multiple doses

    Time frame: Up to 20 weeks

    Area under the concentration-time curve (AUC) of IBI3002 following multiple doses.

  5. Immunogenicity of IBI3002 following multiple doses

    Time frame: Up to 20 weeks

    Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs) in participants receiving IBI3002.

  6. 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

    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.

  7. Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16

    Time frame: 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.

  8. Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16

    Time frame: 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.

  9. Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16

    Time frame: 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.

  10. Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16

    Time frame: 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.

  11. Proportion of participants achieving vIGA-AD 0 or 1 at Week 16

    Time frame: 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.

  12. Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16

    Time frame: 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.

  13. 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

    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.

Study contacts

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

Man Yang

CONTACT

[email protected]

+8618907163461

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 13, 2026

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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