A Study of IBI3033 in Moderate-to-Severe Atopic Dermatitis
ConditionAtopic 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
IBI3033
DrugParticipants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
Placebo
DrugParticipants in placebo group will receive placebo SC.
Treatment groups
16 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: IBI3033 Dose 1 Interval 1Experimental treatment 1 intervention
Group C: IBI3033 Dose 2 Interval 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Percentage of participants who have experienced AEs/SAEs
Time frame
Up to 16 weeksSecondary outcomes
1
PK parameter: Cmax
Observed maximum plasma concentration of IBI3033
Time frame
Up to 16 weeks2
PK parameter: tmax
Time to achieve Cmax of IBI3033
Time frame
Up to 16 weeks3
PK parameter: AUC
Area under the plasma concentration-time curve of IBI3033
Time frame
Up to 16 weeks4
Immunogenticity profiles
Frequency of anti-drug antibody (ADA) of IBI3033
Time frame
Up to 16 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: