Atopic Dermatitis study: IBI3002 vs Dupilumab
Official title A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07399067
What this study is testing
What is IBI3002?
IBI3002 is an investigational once‑weekly injectable medicine being studied as a potential treatment for moderate to severe atopic dermatitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well IBI3002 works and how safe it is for these patients.
- Who it's for
- Adults or children with moderate to severe atopic dermatitis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout...
- 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...
- At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and...
You likely can't join if
- Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular...
- Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node...
- 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.
See the full eligibility criteria
- 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).
- 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.)
- 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...
- 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)...
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.