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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- The proportion of participants who achieved EASI-75
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
- •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.
研究组 & 干预措施
IBI3027 treatment group
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.
干预措施: IBI3027 (Drug)
Dupilumab Injection treatment group
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.
干预措施: Dupilumab Injection (Drug)
结局指标
主要结局
The proportion of participants who achieved EASI-75
时间窗: 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.
次要结局
- The proportion of participants who reached EASI-50(Week16、Week24、Week52)
- The proportion of participants who achieved EASI-90(Week16、Week24、Week52)
- The proportion of participants who reached EASI-75(Week 24＆Week 52)
- 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)
- 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)