A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis

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).

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: IBI3002; Drug: Placebo; Drug: Dupilumab

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Man Yang; Phone Number: +8618907163461; Email: man.yang@innoventbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100192
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Yong Cui; Phone Number: +8615701625913; Email: wuhucuiyong@vip263.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
2. Age between 18 and 75 years old (inclusive).
3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
4. 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.
5. 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.
6. 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.
7. 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:

1. 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.
2. 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.
3. History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
4. History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
5. Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.
6. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.
7. Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.
8. 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.
9. Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matched placebo will be administered subcutaneously according to the study schedule.	Drug: Placebo; Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
Experimental: IBI3002 Dose Level 1 with Dosing Interval 1; Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule.	Drug: IBI3002; IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.; Drug: Placebo; Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
Experimental: IBI3002 Dose Level 1 with Dosing Interval 2; Participants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule.	Drug: IBI3002; IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.; Drug: Placebo; Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
Experimental: IBI3002 Dose Level 2 with Dosing Interval 2; Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule.	Drug: IBI3002; IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.; Drug: Placebo; Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
Experimental: IBI3002 Dose Level 3 with Dosing Interval 2; Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule.	Drug: IBI3002; IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
Active Comparator: Dupilumab; Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg.	Drug: Placebo; Matched placebo will be administered subcutaneously at the same schedule as IBI3002.; Drug: Dupilumab; Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)	Percentage of participants who have experienced AEs/SAEs.	Up to 20 weeks
Pharmacokinetic parameter Cmax of IBI3002 following multiple doses	Maximum observed concentration (Cmax) of IBI3002 following multiple doses.	Up to 20 weeks
Pharmacokinetic parameter Tmax of IBI3002 following multiple doses	Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses.	Up to 20 weeks
Pharmacokinetic parameter AUC of IBI3002 following multiple doses	Area under the concentration-time curve (AUC) of IBI3002 following multiple doses.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 16

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): May 27, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; dupilumab
• Other Study ID Numbers: CIBI3002B201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No