NCT06397911招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in 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
- 招募中
- 入组人数
- 90
- 试验地点
- 16
- 主要终点
- The percentage change from baseline in Eczema Area and Severity Index (EASI) score
研究概览
简要总结
This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.
详细描述
This multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis, with approximately 45 subjects per group.
The study duration of subject participation in the study is up to 28 weeks, including up to 4 weeks for screening, a 12-week study intervention and a 12-week follow-up period after study intervention. The study treatment will be administered as 5 SC doses.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be included in the study:
- •The subject is male or female between 18 and 65 years of age at the time of giving informed consent.
- •Body weight equal to or greater than 40 Kg at the time of screening.
- •The subject has a physician-confirmed diagnosis of moderate-to-severe atopic dermatitis based on 12 months history of symptoms designated by Hanifin and Rajka criteria.
- •Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits.
- •Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 (5-point scale) at the screening and baseline visits.
- •≥10 % 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 of ≥ 3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.
- •History of inadequate response to a stable (4 weeks) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD within 6 months before the screening visit. (The TCS should belong to medium to high potency strength and has been applied for at least 4 weeks or for the maximum duration recommended by product prescribing information.)
- •An inadequate response is defined as the inability to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD 0=clear to 2=mild).
- •Subjects with systemic treatment for AD in the past 6 months were also considered as inadequate responders to topical treatments.
- •Patients must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit.
- •Note: See exclusion criterion #13 for limitations regarding emollients.
- •Female subjects must have a negative serum pregnancy test at screening. All subjects of childbearing potential and his/her sexual partner must meet 2 following condition or acceptable methods of birth control throughout the study.
- •Oral, injectable, or implanted hormonal contraceptives
- •Condom with a spermicidal form, gel, film, cream, or suppository
- •Occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository
- •Intrauterine device
- •Intrauterine system (for example, progestin-releasing coil) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or vasectomy)
- •Postmenopausal (defined as amenorrhea 12 consecutive months and documented serum follicle stimulating hormone level per laboratory standard) Note: The subject must utilize the method of effective contraception during study period as well as 16 weeks or 5 half-lives following the last dosing of FB
- •The subject is able to provide written informed consent.
- •The subject agrees to and is capable of adhering to scheduled visits, the treatment plan, laboratory tests, other study procedures, and all protocol requirements.
排除标准
- •Subjects to whom any of the following applies will be excluded from the study:
- •Female subjects who are pregnant or lactating
- •The subject with positive test results for HBeAg or HCV RNA should be excluded as they are indications of active hepatitis B virus and hepatitis C virus replication.
- •A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or a history of HIV infection.
- •The subject has a history of alcohol or drug abuse within one year prior to screening that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
- •The subject has a clinically significant, currently active or severe gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis and allergic asthma), inflammatory, immunological, endocrine, diabetes, obesity [BMI≥35] or infectious disease and is ineligible to participate in the study as judged by the investigator.
- •The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.
- •The subject has any history of a previous anaphylactic reaction.
- •The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.
- •The subject has received TCS or TCI within 7 days prior to the baseline visit (Day 1).
- •The subject has received any immunoglobulin products or blood products within 3 months prior to baseline visit.
- •The subject has received a biologic product (including investigational biologic product) within 5 half-lives or 3 months, whichever is longer, before baseline visit.
- •The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before baseline visit.
- •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.
- •Initiation of treatment of AD with sedative anti-histamine products during the screening period (patients may continue using stable doses of non-sedative anti-histamine).
- •The subject is a member of the professional or ancillary personnel involved in the study.
- •The subject regular use (≥2 visits per week) of a tanning booth/parlor within 4 weeks prior to the baseline visit.
- •The subject has received cell-based immunotherapy treatment within 3 months prior to baseline visit.
- •The subject has used any of the following classes of medication (prescription or over-the-counter) within specific time frames before the study drug treatment:
- •Systemic corticosteroids within 4 weeks.
- •Leukotriene modifiers within 4 weeks.
- •Cyclosporine within 4 weeks, or other immunosuppressants (e.g. gold salts, methotrexate, azathioprine) within 4 weeks.
- •IFN-γ within 12 weeks, or other immunomodulating drugs within 4 weeks.
- •Allergen immunotherapy within 1 year.
- •JAK inhibitor within 4 weeks.
- •The subject has received phototherapy within 4 weeks before the study drug treatment.
- •The subject has received live vaccine within 12 weeks before the study drug treatment.
- •The subject has presence of skin comorbidities that may interfere with study assessments.
- •The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.
- •The subject has 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 with resolved infection may be rescreened.
- •The subject has history of malignancy within 5 years before the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- •The subject has planned or anticipated the use of any prohibited medications and procedures during the entire study period.
- •The subject has planned or anticipated major surgical procedure during the entire study period.
- •High risk of parasite infection. Evidence of parasitic infection designated as having the following two items:
- •Risk factors for parasitic disease include living in an endemic area, experiencing chronic gastrointestinal symptoms, traveling to regions where geohelminthic infections are endemic within the last 6 months, and/or having chronic immunosuppression).
- •Evidence of parasitic colonization or infection found during stool evaluation for ova and parasites.
- •Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.
研究组 & 干预措施
FB825
Experimental
干预措施: FB825 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
时间窗: Week 16
次要结局
- The percentage change from baseline in Eczema Area and Severity Index (EASI) score(Week 2, 4, 8, 12, 20 and 24)
- The mean change from baseline in Eczema Area and Severity Index (EASI) score(Week 2, 4, 8, 12, 16, 20, and 24)
- Proportion of patients with EASI-75 (≥75% improvement from baseline)(Week 2, 4, 8, 12, 16, 20, and 24)
- Proportion of patients with EASI-50 (≥50% improvement from baseline)(Week 2, 4, 8, 12, 16, 20, and 24)
- Proportion of patients with EASI-90(Week 2, 4, 8, 12, 16, 20, and 24)
- The percentage change from baseline in Investigator Global Assessment (IGA) score(Week 2, 4, 8, 12, 16, 20, and 24)
- Proportion of patients with both Investigator Global Assessment (IGA) 0 to 1 and a reduction from baseline of ≥2 points(Week 2, 4, 8, 12, 16, 20, and 24)
- The percentage change from baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) score(Week 2, 4, 8, 12, 16, 20, and 24)
- The percentage change from baseline in pruritus numerical rating scale (NRS) score(Week 2, 4, 8, 12, 16, 20, and 24)
- The mean change from baseline in Dermatology Life Quality Index (DLQI) score(Week 2, 4, 8, 12, 16, 20, and 24)
- The percentage change from baseline in total IgE(Week 2, 4, 8, 12, 16, 20, and 24)
- The percentage change from baseline in allergen-specific IgE(Week 4, 16, and 24)
研究者
研究点 (16)
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