Atopic Dermatitis
Conditions
Brief 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. 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.
Interventions
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
DRUGIBI3027
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
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants who achieved EASI-75 | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants who reached EASI-75 | Week 24＆Week 52 | — |
| The proportion of participants who reached EASI-50 | Week16、Week24、Week52 | — |
| The proportion of participants who achieved EASI-90 | Week16、Week24、Week52 | — |
| The change in the EASI score compared to the baseline | 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) | Week16、Week24、Week52 | 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. |
| Percentage change in the body surface area affected (BSA) from the baseline | 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 | Week2、Week16、Week24、Week52 | 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. |
Countries
China
Contacts
CONTACTAoling Chen
Outcome results
None listed