Multiple-dose IBI3002 injections to check safety in adults with moderate-to-severe atopic dermatitis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis - a Randomized, Double-Blind, Placebo-Controlled Study

This trial will test multiple subcutaneous doses of IBI3002 in adults (18–65) with moderate-to-severe atopic dermatitis who haven't responded to or cannot use topical treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07015762 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial testing multiple subcutaneous doses of IBI3002 in adults with moderate-to-severe atopic dermatitis. About 9 to 27 participants will be randomized 1:1:1 into three cohorts to receive IBI3002 or matching placebo. The study includes a 4-week screening period, a 12-week dosing period, and an 8-week safety follow-up. Key outcomes include safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and changes in clinical characteristics.

Who should consider this trial

Good fit: Adults aged 18–65, weighing ≥40 kg, with a diagnosis of atopic dermatitis for ≥12 months and disease severity meeting EASI ≥16, IGA ≥3, and BSA ≥10% who have poor response to or are unsuitable for topical treatments are ideal candidates.

Not a fit: Patients with significant comorbid conditions, active or suspected tuberculosis, or those who do not meet the age, weight, or disease severity criteria are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, IBI3002 could become a new systemic option to reduce symptoms and improve skin clearance for adults with moderate-to-severe atopic dermatitis who don't benefit from topical therapy.

How similar studies have performed: Other biologic therapies targeting immune pathways have shown benefit in moderate-to-severe atopic dermatitis, but IBI3002 is at an early phase and its effectiveness has not yet been demonstrated.

Eligibility criteria

Inclusion Criteria:

1. Between 18 and 65 years.
2. Weight ≥40kg.
3. Meet the diagnostic criteria of the Hannifin \& Rajka criteria, and have been diagnosed with AD for ≥12 months at screening. If determined by Investigators, previous diagnostic terms like "dermatitis" and "eczema" are also acceptable.
4. Have an Eczema area and severity index (EASI) score ≥16, the Investigator´s Global Assessment score ≥3, and the involved Body Surface Area (BSA) ≥10% at screening and randomization.

Exclusion Criteria:

1. Having any disease that have an impact on the participant's own safety or participation in the study. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system, in the opinion of Investigator.
2. Participants with a known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis; Or there is any other clinical evidence of latent tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first dose until the end of the study. If the participant is judged by Investigator to be intolerant to preventive anti-tuberculosis treatment, they should not be included in the study either.
3. A history of malignant tumors, except for resected or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
4. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value, at screening or randomization.
5. The co-existing of any other skin comorbidities that may interfere with the assessment related to AD, in the opinion of Investigators.

The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wensheng Zang

Conditions Atopic Dermatitis