Can a new injection match an existing eczema treatment?
NCT ID NCT07754786
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing whether an experimental biologic called IBI3027 works as well as the approved drug dupilumab for people with moderate-to-severe atopic dermatitis (eczema). About 520 adults will be randomly assigned to receive either IBI3027 or dupilumab as a subcutaneous injection every two weeks for about 44 weeks. The main goal is to see if IBI3027 can achieve a 75% improvement in eczema severity, as measured by the EASI score, similar to dupilumab.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI3027, an experimental biologic similar to dupilumab, given as an injection every two weeks
- What this could lead to
- If IBI3027 proves equivalent to dupilumab, it could offer another effective treatment option for people with moderate-to-severe atopic dermatitis, potentially increasing access and affordability.
- What could go wrong
- This is a phase 3 trial, but equivalence is not guaranteed. IBI3027 may not match dupilumab's effectiveness or safety, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 520 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Southern Medical University Dermatology Hospital Medicine
Guangzhou, Guangdong, 510091, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?