NCT03496974已完成2 期
A Phase II, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients 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
- 38
- 试验地点
- 1
- 主要终点
- Number of Patients With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.
详细描述
A Phase 2, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients with Moderate to Severe Atopic Dermatitis. The study is multi center and will consist of two dose levels:
Group A (n=9): patients will receive a total of 4 x 200mg subcutaneous injections of bermekimab. Dosing will occur weekly from visit 1 to visit 4, inclusive.
Group B (n=20): patients will receive a total of 8 x 400 mg subcutaneous injections of bermedimkb. Dosing will occur weekly from visit 1 to visit 8, inclusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent provided by the patient
- •Age 18 years or greater
- •Chronic Atopic Dermatitis present for at least 3 years
- •Disease is not responsive to topical medications, or for whom topical treatments are not indicated or desired.
- •Willing and able to comply with all clinic visits and study-related procedures
- •EASI score ≥16 at screening and baseline visits
- •IGA score ≥3 at screening and baseline visits
- •≥10% body surface area (BSA) of AD involvement at screening and baseline visits
- •Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable or undesired.
排除标准
- •Treatment with an investigational drug within 8 weeks of baseline visit
- •Having received the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- •Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •Phototherapy for AD
- •Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit
- •Initiation of treatment during the screening period with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
- •Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- •History of severe allergic or anaphylactic reactions to monoclonal antibodies.
- •Administration of any live (attenuated) vaccine within 4 weeks prior to the baseline.
- •Any history of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
- •Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
- •Presence of skin comorbidities that may interfere with study assessments
- •Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to, patients with short life expectancy, patients with uncontrolled diabetes (HbA1c ≥ 9%), patients with cardiovascular conditions (eg, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, case report forms [CRFs], etc.)
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- •Where relevant, women unwilling to use adequate birth control
研究组 & 干预措施
Group B: 400 mg cohort
Experimental
The dose of bermekimab for Group B is 400 mg (2ml of the 200 mg/ml formulation) administered weekly by subcutaneous injection
干预措施: Bermekimab Monoclonal Antibody 400 mg (Drug)
Group A: 200 mg cohort
Experimental
The dose of bermekimab for Group A is 200 mg (2ml of the 100 mg/ml formulation)
干预措施: Bermekimab Monoclonal Antibody 200 mg (Drug)
结局指标
主要结局
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
时间窗: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
次要结局
- Number of Patients Achieving 50% or Greater Reduction in SCORAD Score at Week 7(Group A: Week 4; Group B: Week 7)
- Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Number of Patients Achieving 50% or Greater Reduction in EASI Score at Week 7(Group A: Week 4; Group B: Week 7)
- Change in Global Individual Signs Score (GISS) From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Pharmacokinetics (PK) Assessment at Week 7(Group A: Week 4; Group B: Week 7)
- Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Change in HADS (Depression) Score From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7(Group A: Week 4; Group B: Week 7)
- Number of Patients Achieving ≥2 IGA Score Reduction at Week 7(Group A: Week 4; Group B: Week 7)
- Change in HADS (Anxiety) Score From Baseline to Week 7(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
- Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.(Group A: Baseline to Week 4; Group B: Baseline to Week 7)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic DermatitisEczemaAtopic DermatitisNCT04021862Janssen Research & Development, LLC87
未知
2 期
A phase 2a study of M520102 in atopic dermatitis patientsatopic dermatitisJPRN-jRCT2080221901Maruho Co.,Ltd.
已完成
2 期
A Study of Bermekimab in Patients With Hidradenitis SuppurativaHidradenitis SuppurativaNCT03512275Janssen Research & Development, LLC42
已完成
2 期
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT06585202Aclaris Therapeutics, Inc.14
已完成
2 期
An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.Atopic DermatitisNCT04922021LEO Pharma58