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

NCT07399067 | Recruiting Phase 2

• 1 other identifier: CIBI3002B201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

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

  Up to 20 weeks

• Pharmacokinetic parameter Cmax of IBI3002 following multiple doses

  Up to 20 weeks

• Pharmacokinetic parameter Tmax of IBI3002 following multiple doses

  Up to 20 weeks

• Pharmacokinetic parameter AUC of IBI3002 following multiple doses

  Up to 20 weeks

• Immunogenicity of IBI3002 following multiple doses

  Up to 20 weeks

Study Arms (6)

IBI3002 Dose Level 2 with Dosing Interval 2

EXPERIMENTAL

Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule.

Drug: IBI3002; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Matched placebo will be administered subcutaneously according to the study schedule.

Drug: Placebo

IBI3002 Dose Level 3 with Dosing Interval 2

EXPERIMENTAL

Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule.

Drug: IBI3002

IBI3002 Dose Level 1 with Dosing Interval 1

EXPERIMENTAL

Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule.

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.

Drug: IBI3002; Drug: Placebo

Dupilumab

ACTIVE COMPARATOR

Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg.

Drug: Placebo; Drug: Dupilumab

Interventions

IBI3002 DRUG

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

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

Placebo DRUG

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

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

Dupilumab DRUG

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

Dupilumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100192, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Man Yang

CONTACT

+8618907163461; man.yang@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 10, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): May 27, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)