A Phase 3 interventional study of Dupilumab Injection and IBI3027 in Atopic Dermatitis, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 3, Interventional, and Treatment
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).
After screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 520 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key inclusion criteria:
Key exclusion criteria：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group of subjects will be treated with Dupilumab injection. On Day 1, a loading dose of 600 mg will be administered, followed by 300 mg every two weeks until Week 44.
Drug: Dupilumab Injection
This group of subjects will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44.
Drug: IBI3027
The participants in Dupilumab injection treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44
The participants in IBI3027 treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44
The proportion of participants who achieved EASI-75
EASI is an assessment tool used to evaluate the severity of atopic dermatitis and the extent of skin lesions involved. The score of EASI ranges from 0 to 72 points. The higher the score, the more severe the disease. EASI divides the affected areas into four regions: head and neck, trunk, upper limbs, and lower limbs. Scores are given for each region based on the area of involvement. The severity of skin lesions in each region is calculated according to the severity of erythema, sclerosis or papules, epidermal desquamation, and lichenification. Finally, the scores of the four regions are added together to obtain the total score.
Time frame: Week 16
The proportion of participants who reached EASI-75
Time frame: Week 24＆Week 52
The proportion of participants who reached EASI-50
Time frame: Week16、Week24、Week52
The proportion of participants who achieved EASI-90
Time frame: Week16、Week24、Week52
The change in the EASI score compared to the baseline
The Eczema Area and Severity Index (EASI) score is an assessment tool used to evaluate the severity of atopic dermatitis (AD) and the extent of affected skin lesions. The score of EASI ranges from 0 to 72, with a higher score indicating a more severe disease condition.
Time frame: Week16、Week24、Week52
The overall assessment by the researchers - the proportion of participants who achieved treatment success (IGA-TS, with an IGA score of 0 or 1 and a reduction of ≥ 2 points from the baseline)
The Investigator's Global Assessment Scale for Atopic Dermatitis (IGA) is a 5-point classification scale based on the overall appearance of skin lesions at a specific time point (0 = cleared; 1 = largely cleared; 2 = mild; 3 = moderate; 4 = severe). It is evaluated by the researchers.
Time frame: Week16、Week24、Week52
Percentage change in the body surface area affected (BSA) from the baseline
Time frame: Week16、Week24、Week52
The proportion of participants whose weekly average score on the Peak Pruritus Numerical Rating Scale (PP-NRS) decreased by ≥ 3 points compared to the baseline
The Pruritus Numerical Rating Scale (PP-NRS) is used to allow participants to report the severity of their pruritus over the past 24 hours. The most severe pruritus is represented by a single-item NRS, with a score range of 0 to 10. Participants are required to use the scale to evaluate the intensity of their most severe pruritus, with 10 representing the highest level of pruritus.
Time frame: Week2、Week16、Week24、Week52
Started Sep 2026 (actual). Primary completion is estimated for Jul 2028, 21 months after the start.
Of 149 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 28. This study's planned 21 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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