A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 128
- 主要终点
- Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16
研究概览
简要总结
The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
- •Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form [ICF]) and with:
- •validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
- •Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
- •Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
- •≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
- •Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy
排除标准
- •Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
- •Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis
- •Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
- •History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator
- •Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
- •Previous treatment with galvokimig
- •Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment
- •All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
- •Treatment with biologic agents must discontinued at least 3 months prior to baseline
研究组 & 干预措施
Galvokimig Arm 2
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
干预措施: Galvokimig (Biological)
Galvokimig Arm 1
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
干预措施: Galvokimig (Biological)
Galvokimig Arm 3
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
干预措施: Galvokimig (Biological)
Placebo
Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
干预措施: Galvokimig (Biological)
Placebo
Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16
时间窗: Week 16
The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. The severity of each clinical sign is scored as: 0=None to 3=Severe.
次要结局
- Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16(Week 16)
- Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16(Baseline and Week 16)
- Incidence of TE Serious Adverse Events (SAEs)(Up to Week 58)
- Incidence of Treatment-Emergent (TE) Adverse Events (AE)(Up to Week 58)