A Study of IBI3033 in Moderate-to-Severe Atopic Dermatitis

NCT07549984 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3033A103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of IBI3033 in subjects with moderate-to-severe atopic dermatitis (AD). Approximately 16 eligible adult participants will be enrolled and sequentially assigned to one of two dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive IBI3033 or matching placebo. The study consists of a screening period (up to 4 weeks), a 12-week treatment period, and a 4-week safety follow-up period. The primary objective is to assess safety and tolerability based on the incidence of adverse events and serious adverse events. Secondary objectives include characterization of pharmacokinetics and immunogenicity. Exploratory assessments include pharmacodynamic biomarkers and preliminary efficacy outcomes such as changes in Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (vIGA-AD) scores.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)/serious adverse events (SAEs)

  Percentage of participants who have experienced AEs/SAEs

  Up to 16 weeks

Secondary Outcomes (10)

• PK parameter: Cmax

  Up to 16 weeks

• PK parameter: tmax

  Up to 16 weeks

• PK parameter: AUC

  Up to 16 weeks

• Immunogenticity profiles

  Up to 16 weeks

• Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 12

  Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants in placebo group will receive placebo SC.

Drug: Placebo

IBI3033 Dose 1 Interval 1

EXPERIMENTAL

Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

Drug: IBI3033

IBI3033 Dose 2 Interval 2

EXPERIMENTAL

Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

Drug: IBI3033

Interventions

IBI3033 DRUG

Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

IBI3033 Dose 1 Interval 1; IBI3033 Dose 2 Interval 2

Placebo DRUG

Participants in placebo group will receive placebo SC.

Placebo

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)

Hangzhou First People's Hospital

Hangzhou, Hangzhou, 310006, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Wenjing Duan

CONTACT

010-87412310; wenjing.duan@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: April 19, 2026
• First Posted: April 24, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)