NCT05544591已完成2 期
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
研究概览
简要总结
The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis.
详细描述
The maximum study duration was 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
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
- •Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- •Male or female adults ages 18 to 64 years old when signing the informed consent.
- •AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 1 years before the screening visit.
- •Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
- •Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
- •Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
- •Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=
- •Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- •Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit.
- •Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.
排除标准
- •Presence of skin comorbidities that may interfere with study assessments
- •Presence of active endoparasitic infections; or suspected endoparasitic.
- •Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- •History of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
- •Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
- •Active TB, unless that was well documented that the participants had adequately treated.
- •Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study
- •Patients who have received any of the following treatments: a) Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 weeks before baseline; b) Treatment with systemic traditional Chinese medicine (TCM) within 4 weeks before baseline or treatment with topical TCM; c) Have undergone bleaching baths ≥ twice within 2 weeks before baseline; d) Treatment with systemic corticosteroids or other immunosuppressive/immunomodulating substances (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, interferon-gamma [IFN-γ], oral JAK inhibitors, compound glycyrrhizin, azathioprine, mycophenolate mofetil, or methotrexate,) within 4 weeks before baseline or 5 drug half-lives (if known), whichever is longer; e) Treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light emitting device (LED) therapy within 4 weeks before baseline; f) Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline. Treatment with other biological agents (e.g., dupilumab) within 3 months before baseline or 5 drug half-lives (if known), whichever is longer; g) History of inadequate response to treatment with anti-IL-4 and/or IL13 agents (e.g., dupilumab), in the opinion of the investigator. h) Treatment with allergen specific immunotherapy (SIT) within 6 months before the screening visit. i) Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit).
- •Presence of any one of the following lab abnormalities at screening or baseline: a) Total bilirubin > 1.5 times the upper limit of normal (ULN); b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 ULN; c) Serum creatinine (Cr) > 1.5×ULN; d) White blood cell count below the lower limit of normal (LLN) , was judged clinically significant by the investigator, and not suitable for inclusion in the study;
- •HBsAg-positive with HBV DNA copy number beyond normal limit of the HBV DNA test, or HCV antibodies (HCV Ab)-positive with HCV RNA copy number beyond normal limit of the HCV RNA test, human immunodeficiency virus antibody (HIV Ab) positive, serum syphilis helix antibody (TP Ab) positive with syphilis helix titrating positive at screening;
- •History of alcohol or drug abuse within 6 months before baseline.
- •History of hypersensitivity to 611 or their excipients.
- •Have been vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period;
- •Have used any investigational drug/treatment within 8 weeks before baseline;
- •Planned or anticipated major surgical procedure during the patient's participation in this study.
- •Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
- •Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
611 Q2W
Experimental
Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q2w from Week 2 to Week 14 (7 cycles).
干预措施: 611 Q2W (Drug)
611 Q4W
Experimental
Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q4w on week 4, 8, 12 and two injections of placebo on week 2, 6, 10, 14.
干预措施: 611 Q4W (Drug)
placebo
Placebo Comparator
Four subcutaneous injections of placebo as a loading dose on week 0 Day 1, followed by two injections q2w from Week 2 to Week 14 (7 cycles).
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
时间窗: Baseline, Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
次要结局
- Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16(Baseline, Week 16)
- Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16(Baseline, Week 16)
- Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16(Baseline to Week 16)
- Number of Participants Who Achieve Improvement of IGA Score by >=2 From Baseline to Week 16(Baseline to Week 16)
- Number of Participants Who Achieved >=4 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline to Week 16)
- Number of Participants Who Achieved >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline to Week 16)
- Percentage Change From Baseline to Week 16 in EASI Score(Baseline to Week 16)
- Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement(Baseline to Week 16)
- Change From Baseline at Week 16 in Weekly Average of Pruritus NRS(Baseline to Week 16)
- Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score(Baseline to Week 16)
- Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)(Baseline to Week 16)
- Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.(Up to 24 Weeks)
- Maximum Concentration (Cmax).(Baseline to Week 24.)
- Minimum concentration (Cmin).(Baseline to Week 24.)
- Time to Reach the Maximum Concentration (Tmax).(Baseline to Week 24.)
- Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last).(Baseline to Week 24.)
- AUC to the end of the dosing period (AUC0-tau)(Baseline to Week 24.)
- Clearance rate (CL/F).(Baseline to Week 24.)
- Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.(Baseline to Week 24.)
- Change in serum concentrations of Thymus and activation regulated chemokine (TARC)(Baseline to Week 24.)
- Change in serum concentrations of IL-4(Baseline to Week 24.)
- Change in serum concentrations of IL-13(Baseline to Week 24.)
- Change in serum concentrations of IgE(Baseline to Week 24.)
- Change in whole blood eosinophil counts(Baseline to Week 24.)
- Change in serum concentrations of lactate dehydrogenase (LDH)(Baseline to Week 24.)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT06099652Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.142
已完成
3 期
Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic DermatitisDermatitis, AtopicNCT06173284Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.519
招募中
3 期
Efficacy and Safety Study of 610 in Patients With Severe AsthmaAsthmaNCT06323213Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.480
已完成
1 期
Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic DermatitisDermatitis, AtopicNCT05641558Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.24
已完成
1 期
Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic DermatitisDermatitis, AtopicNCT06324812Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.128