See if IBI3027 works as well as Dupilumab for 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

In this Phase 3 trial, about 520 adults with moderate to severe atopic dermatitis are randomized 1:1 to receive either IBI3027 or Dupilumab injections over 44 weeks, with a loading dose followed by biweekly dosing, and an 8-week safety follow-up. Participants undergo screening, a 44-week treatment period, and an 8-week post-treatment safety period. The study uses objective skin assessments and patient-reported scores to compare efficacy and safety between the two treatments. The primary comparison focuses on whether IBI3027 yields similar clinical outcomes to Dupilumab, with standard inclusion and exclusion criteria to select eligible adults who have not adequately responded to topical therapies. Conducted at a single center in Guangzhou, the trial is led by Innovent Biologics with collaboration from the Southern Medical University Dermatology Hospital.

Why it matters

Who can join: the full rules

Key inclusion criteria:

1. Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;
2. Male or female participants aged 18 to 75;
3. AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;
4. Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;
5. Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;
6. As assessed by investigator, records indicating poor treatment response with topical local medications, or not suitable for topical treatment due to other medical reasons (such as severe adverse reactions or safety risks, etc.), within 6 months prior to the screening

Key exclusion criteria：

1. Have active skin diseases that may affect the assessment of AD (such as psoriasis or lupus erythematosus), or other skin complications caused by other diseases. Those who are in an acute exacerbation state of AD at the time of randomization (such as participants having rapidly progressing erythroderma or a tendency towards erythroderma, as assessed by the investigators);
2. Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;
3. Suspected immunosuppressive disease within 6 months prior to screen;
4. Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);
5. Participants at high risk of infection;
6. Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;
7. Positive for human immunodeficiency virus (HIV) antibody;
8. Participants with syphilis infection;
9. Positive for the hepatitis C virus (HCV) antibody and HCV RNA (if HCV antibody positive);
10. Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA (if HBsAg positive);
11. Previous use IL-4 and/or IL-13 targeting drugs (such as dupilumab, etc.) for the treatment of AD with no response or poor efficacy;
12. Systemic use of IL-4Rα or IL-13 antibody treatment ≤ 3 months or 5 half-lives (if the half-life is known) prior to randomization;
13. ≥ 2 bleach baths ≤ 2 weeks prior to randomization;
14. Use of drugs containing main active ingredients such as compound glycyrrhizin or total polysaccharides of peony ≤ 2 weeks prior to randomization;
15. Following treatments ≤4 weeks prior to randomization: a. systemic use of glucocorticoids or immunosuppressants; b. systemic use of traditional Chinese medicine; c. calcium channel-based anti-epileptic drugs, anti-serotonin agents, and opioid receptor antagonists, with antipruritic effects; d. ultraviolet therapy.
16. Treatment of allergen-specific immunotherapy ≤ 6 months prior to randomization;
17. Use of any cell depletion agents including but not limited to rituximab ≤12 months prior to randomization.

Where it's running

• Southern Medical University Dermatology Hospital Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Aoling Chen
• Email: aoling.chen@innoventbio.com
• Phone: 0512-69566088

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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.