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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • IBI3033
  • Placebo

Treatment groups

16 Participants
are divided into 3 treatment groups