RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Dupilumab Injection for Atopic Dermatitis

This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio. Study period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).

Official registry: https://clinicaltrials.gov/study/NCT07754786 · Innovent Biologics (Suzhou) Co. Ltd. · enrollment listed as 520

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dupilumab Injection, or IBI3027. The registry lists allocation as randomized. This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.

They plan to enroll about 520 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multicenter, Randomized, Double-blind, Parallel, and Positive-controlled Phase III Clinical Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis

Interventions: Dupilumab Injection, IBI3027

Primary outcome (registry wording): The proportion of participants who achieved EASI-75

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;
Male or female participants aged 18 to 75;
AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;
Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;
Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;
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

Who the registry excludes

Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;
Suspected immunosuppressive disease within 6 months prior to screen;
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);
Participants at high risk of infection;
Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;
Positive for human immunodeficiency virus (HIV) antibody;
Participants with syphilis infection;

Public study contact (from the registry)

Aoling Chen

0512-69566088

aoling.chen@innoventbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Southern Medical University Dermatology Hospital Medicine — Guangzhou, Guangdong, China (recruiting)

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FAQ about this NCT record

Is NCT07754786 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07754786?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07754786?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary