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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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).

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

  • IBI3002
  • Placebo
  • Dupilumab

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.