Atopic DermatitisPhase 3NCT07754786
A Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing Dupilumab Injection and IBI3027 in people with Atopic Dermatitis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab Injection and IBI3027
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 26 Aug 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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);
- 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;
Show all 17Show fewer
- Positive for human immunodeficiency virus (HIV) antibody;
- Participants with syphilis infection;
- Positive for the hepatitis C virus (HCV) antibody and HCV RNA (if HCV antibody positive);
- Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA (if HBsAg positive);
- 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;
- 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;
- ≥ 2 bleach baths ≤ 2 weeks prior to randomization;
- Use of drugs containing main active ingredients such as compound glycyrrhizin or total polysaccharides of peony ≤ 2 weeks prior to randomization;
- 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.
- Treatment of allergen-specific immunotherapy ≤ 6 months prior to randomization;
- Use of any cell depletion agents including but not limited to rituximab ≤12 months prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southern Medical University Dermatology Hospital Medicine
Guangzhou, Guangdong, 510091
Bin Yang, 020-83482482, yangbin101@hotmail.com
Fang Wang, 020-83482482, wangf78@smu.edu.cn
About this study
Official title: 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
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab Injection, IBI3027
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab InjectionDrug
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
IBI3027Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab Injection treatment group | Active comparator | 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. Receives: Drug: Dupilumab Injection |
| IBI3027 treatment group | Experimental | 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. Receives: Drug: IBI3027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (7)
The proportion of participants who reached EASI-75
Measured: Week 24＆Week 52
The proportion of participants who reached EASI-50
Measured: Week16、Week24、Week52
The proportion of participants who achieved EASI-90
Measured: 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.
Measured: 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.
Measured: Week16、Week24、Week52
Percentage change in the body surface area affected (BSA) from the baseline
Measured: 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.
Measured: Week2、Week16、Week24、Week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start15 Sep 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion26 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754786
- Sponsor's protocol ID
- CIBI3027A301
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No