NCT07291284进行中（未招募）3 期
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis Inadequately Controlled by Standard-of-care
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2024年8月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 546
- 试验地点
- 1
- 主要终点
- Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female, aged 18 to 65 years
- •Subjects with SAR for at least 2 years
- •At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period
- •Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening
- •Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization
排除标准
- •Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis
- •Subjects with perennial allergic rhinitis (PAR)
- •Underwent any nasal or sinus surgery within 1 year prior to screening
- •Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections
- •Clinically significant conditions upon the judgement of investigator
- •Subjects with concomitant asthma who, upon the judgement of investigator, require inhaled corticosteroid treatment during the study
- •The laboratory results at screening: a) white blood cell (WBC) < 2.5×10^9/L; b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ×upper limit of normal (ULN) or total bilirubin > 1.5 ×ULN; c) Serum creatinine (Cr) > 1.5 × ULN
- •Received treatment with similar drugs (e.g., Omalizumab) or used LP-003 Injection within 6 months prior to screening
- •Received systemic glucocorticoids within 4 weeks prior to screening
- •Received intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, or antihistamine medications within 1 week prior to randomization
- •Received traditional Chinese medicine treatment for allergic rhinitis within the 7 days prior to randomization
- •Received allergen immunotherapy within 6 months prior to screening (for those who have not completed the therapy), or within 3 years prior to screening (for those who have completed the therapy)
- •Subjects for whom exposure to allergens in the home or work environment are expected to undergo significant changes during the trial, as assessed by the investigator, which may interfere with the evaluation of efficacy
- •Subjects planning to travel outside their area of residence during the trial to an area without pathogenic pollen, for either 2 consecutive days or a total duration exceeding three days
研究组 & 干预措施
Experimental: LP-003
Experimental
Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks.
干预措施: LP-003 (Biological)
Placebo Comparator：Placebo
Placebo Comparator
Participants received subcutaneous of Placebo Injection once every 4 weeks.
干预措施: Placebo (Biological)
结局指标
主要结局
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
时间窗: Up to 4 Months
The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity.
次要结局
- Mean daily rTNSS during the pollen period (PP)(Up to 4 Months)
- Mean daily total ocular symptom score (TOSS) during the PPP(Up to 4 Months)
- Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP(Up to 4 Months)
- Mean daily iTNSS during the PP(Up to 4 Months)
- Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP(Up to 4 Months)
- Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP(Up to 4 Months)
- Mean daily rescue medication score (RMS) during the PPP(Up to 4 Months)
- Incidence of adverse events (AEs)(Up to Week 28)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyNCT07266805Pharvaris Netherlands B.V.32
尚未招募
3 期
A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）NCT07274137MindRank AI Ltd738
招募中
2 期
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT07292714Mabwell (Shanghai) Bioscience Co., Ltd.360
招募中
2 期
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)NCT07280156Protalix150
招募中
2 期
Topical Ketotifen 0.25% for Secondary VestibulodyniaNCT07257029Center for Vulvovaginal Disorders54