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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Wensheng Zang
• Email: wensheng.zang@innoventbio.com
• Phone: 15210342569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

  Recruiting at 4 sites Phase 3 Arcutis Biotherapeutics, Inc. · Birmingham, Alabama and 3 other locations · NCT07916480

• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

  This study tests whether the Replior ScratchSense ring can accurately detect and measure nighttime scratching in adults with itchy skin conditions.

  Recruiting Replior AB · Grenoble · NCT07909967

• ADBest TREAT Registry for adults with atopic dermatitis

  A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.

  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg · NCT07904546

• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

  This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Copenhagen · NCT07807228

• QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis

  This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.

  Recruiting Phase 1 QuantX Biosciences US Inc. · Shanghai, Shanghai Municipality · NCT07800104

• Tilrekimig for moderate-to-severe eczema in teens and adults

  A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.

  Recruiting at 31 sites Phase 3 Pfizer · Birmingham, Alabama and 49 other locations · NCT07783425

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.