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임상시험 NCT07060885은(는) 알레르기성 비결막염, 알레르기 비염에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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ALK-아벨로 A/SA Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65 3상 300
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임상시험 NCT07060885은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 알레르기성 비결막염, 알레르기 비염에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 9월 1일에 시작되어 300명의 참여자를 모집하고 있습니다. ALK-아벨로 A/S이(가) 진행하며, 2026년 8월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 31일에 갱신되었습니다.
간단한 개요
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
상세한 설명
The trial aims to evaluate efficacy of the house dust mite (HDM) SLIT-tablet compared to placebo in Chinese participants aged 12-65 with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment.
The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial cond...
더 보기공식 제목
A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
질환명
알레르기성 비결막염알레르기 비염기타 연구 식별자
- MT-21
- 2025-000321-14 (EudraCT 번호)
NCT 번호
실제 연구 시작일
2025-09-01
최신 업데이트 게시
2025-12-31
예상 연구 완료일
2026-08
계획된 등록 인원
300
연구종류
중재연구
단계/상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Active treatment HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. | HDM SLIT-tablet (12 SQ-HDM) For daily administration (1 tablet per day)
Other Names: Acarizax, Odactra |
위약 대조군Placebo Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. | 위약 For daily administration (1 tablet per day) |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period. | The average daily TCRS evaluates the treatment effect as the difference in daily rhinitis symptoms and medication score (on a scale from 0-24) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period. | The average rhinitis DSS evaluates the treatment effect as the difference in daily rhinitis symptoms score (on a scale from 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
Average daily values for rhinitis daily medication score (DMS) during primary efficacy period. | Average rhinitis DMS evaluates the treatment effect as the difference in daily rhinitis medication use (on a scale of 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
Average daily total combined score (TCS) during primary efficacy period. | Average rhinoconjunctivitis TCS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
Average rhinoconjunctivitis DSS during the primary efficacy assessment period | The average rhinoconjunctivitis DSS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptom score (on a scale of 0-18) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
Average rhinoconjunctivitis DMS during the primary efficacy assessment period | The average rhinoconjunctivitis DMS evaluates the treatment effect as the difference in daily rhinoconjunctivitis medication use (on a scale of 0-20) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
12 Years
참여 가능한 성별
전체
- Male or female Chinese subjects aged 12-65 years
- A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
- Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
- Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
- Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
- Lung function ≥ 70% of predicted value
- Sensitised and regularly exposed to perennial allergens
- Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
- Asthma requiring treatment with high dose of inhaled corticosteroid
- A relevant history of systemic allergic reaction
ALK-아벨로 A/S3개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Head of Clinical Project Management, +45 45747576, [email protected]
30 1개국에 임상시험 장소
Beijing Municipality
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, 100730, China
Chengshuo Wang Principal Investigator, 연락처, 13911623569, [email protected]
Yuyang Dai GCP Secretary, 연락처, 58268486-8011, [email protected]
Chengshuo Wang, 책임연구자
모집중
Fujian
Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China
Ting Chen Principal Investigator, 연락처, 059188216004, [email protected]
Jing Deng, 연락처, 0591-88216004, [email protected]
Ting Chen, 책임연구자
모집중
The first hospital affiliated Fujian medical University, Fuzhou, Fujian, 350005, China
Yuanteng Xu Principal Investigator, 연락처, 059187981262, [email protected]
Anpeng Wu, 연락처, 0591-87981262, [email protected]
Yuanteng Xu, 책임연구자
모집중
Guangdong
The first affiliated hospital of guangzhou medical university-respiratory department, Guangzhou, Guangdong, 510120, China
Jing Li Principal Investigator, 연락처, 18928868259, [email protected]
Gesi Wen, 연락처, 15914303910, [email protected]
Jing Li, 책임연구자
모집중
The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510630, China
Qintai Yang Principal Investigator, 연락처, 13724859848, [email protected]
Denglai Liu, 연락처, 020-85253153, [email protected]
Qintai Yang, 책임연구자
모집중
The Third Affilliated Hospital of Southern Medical University, Guangzhou, Guangdong, 510630, China
Guangyong Tian Principal Investigator, 연락처, 13430359092, [email protected]
Xiangfei Song, 연락처, 020-62784066, [email protected]
Guangyong Tian, 책임연구자
모집중
Shenzhen Children's Hospital - Respiratory, Shenzhen, Guangdong, 518026, China
Yuejie Zheng Principal Investigator, 연락처, 8618938690506, [email protected]
Jiapeng He 何家朋 GCP office secretary, 연락처, 0755-83008184, [email protected]
Yuejie Zheng, 책임연구자
모집중
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology, Shenzhen, Guangdong, 518052, China
Liang Chen Principal Investigator, 연락처, 8618898589170, [email protected]
Jingfeng Qin GCP Secretary, 연락처, 0755-26553111, [email protected]
Liang Chen, 책임연구자
모집중
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital, Zhuhai, Guangdong, 510275, China
Haiyu Hong Principal Investigator, 연락처, 13823070089, [email protected]
Ming Ye 叶明 GCP office secretary, 연락처, 0756-2528188, [email protected]
Haiyu Hong, 책임연구자
모집중
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Guangyao He Principal Investigator, 연락처, 7715356566, [email protected]
Ni Liu, 연락처, 0771-5309187, [email protected]
Guangyao He, 책임연구자
모집중
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology, Nanning, Guangxi, 530021, China
Shenhong Qu Principal Investigator, 연락처, 8607712186318, [email protected]
Bi Deng, 연락처, 0771-2186742, [email protected]
Shenhong Qu, 책임연구자
모집중
Hainan
Hainan General Hospital - Respiratory, Haikou, Hainan, 570311, China
Xin Wei Principal Investigator, 연락처, 13016296267, [email protected]
Haiyu Xue GCP Secretary, 연락처, 13976989559, [email protected]
Xin Wei, 책임연구자
모집중
Henan
The Third Hospital of Changsha - Pulmonology, Changshacun, Henan, 410015, China
Ming Yang Principal Investigator, 연락처, 13017280697, [email protected]
Zhiya Hu 胡智雅 GCP office secretary, 연락처, 0731-85171463/ 1524307708, [email protected]
Ming Yang, 책임연구자
모집중
The First Affiliated Hospital of University of South China - Endocrinology, Hengyang, Henan, 421001, China
Qingshan Jiang Principal Investigator, 연락처, 07348312320, [email protected]
Pengju Ye，Juan Wen, 연락처, 0734-8578930, 0734-8578934, [email protected]
Qingshan Jiang, 책임연구자
모집중
Hubei
Jingzhou Central Hospital - Otorhinolaryngology, Jingzhou, Hubei, 434020, China
Lijia Wan Principal Investigator, 연락처, 18972160068, [email protected]
Zhen Xu, 연락처, 0716- 8487552, [email protected]
Lijia Wan, 책임연구자
모집중
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology, Wuhan, Hubei, 430022, China
Jianjun Chen Principal Investigator, 연락처, 13659851719, [email protected]
Li Zhang, 연락처, 13026327780, [email protected]
Jianjun Chen, 책임연구자
모집중
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, 430030, China
RongFei Zhu Principal Investigator, 연락처, + 8600000000, [email protected]
Han Bai, 연락처, 027-83662379, [email protected]
RongFei Zhu, 책임연구자
모집중
Jiangsu
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology, Nanjing, Jiangsu, 210029, China
Lei Cheng Principal Investigator, 연락처, + 8600000000, [email protected]
Peipei Shi, 연락처, 025-68306156, [email protected]
Lei Cheng, 책임연구자
모집중
The First Affiliated Hospital of Soochow University - Respiratory, Suzhou, Jiangsu, 215006, China
YaFeng Yu Principal Investigator, 연락처, 51265223637, [email protected]
Ju Qian, 연락처, 0512-67972858, [email protected]
YaFeng Yu, 책임연구자
모집중
Jiangxi
Nanchang University - The First Affiliated Hospital, Nanchang, Jiangxi, 330046, China
Jing Ye Principal Investigator, 연락처, 13979161109, [email protected]
Duanwen Cao, 연락처, 0791-8869 5125, [email protected]
Jing Ye, 책임연구자
모집중
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330047, China
Hongbing Liu Principal Investigator, 연락처, 13007452129, [email protected]
Zhao Yuan袁钊 GCP office secretary, 연락처, 0791-86300985, [email protected]
Hongbing Liu, 책임연구자
모집중
Shaanxi
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology, Xi'an, Shaanxi, 710004, China
Kang Zhu Principal Investigator, 연락처, 15829292533, [email protected]
Yang Zhao, 연락처, 15129006956, [email protected]
Kang Zhu, 책임연구자
모집중
Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
Wei Tang Principal Investigator, 연락처, 18917080579, [email protected]
Jiajie Wu, 연락처, 021-64370045, [email protected]
Wei Tang, 책임연구자
모집중
Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
Mei ling Principal Investigator, 연락처, + 8600000000, [email protected]
연락처, 021-31587861, [email protected]
Mei ling, 책임연구자
모집중
Sichuan
Peking Union Medical College Hospital, Beijing, Sichuan, 100730, China
Kai Guan Principal Investigator, 연락처, 8613611113032, [email protected]
Chi Zhang, 연락처, 010-69154116, [email protected]
Kai Guan, 책임연구자
모집중
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital), Chengdu, Sichuan, 610017, China
Ping Wei Principal Investigator, 연락처, 13647684008, [email protected]
Weiyi Guo, 연락처, 028-85503776, [email protected]
Ping Wei, 책임연구자
모집중
West China Hospital of Sichuan University - Otorhinolaryngology, Chengdu, Sichuan, 610041, China
Juan Meng Principal Investigator, 연락처, 85422114, [email protected]
Hao Xiao, 연락처, 18227603630, [email protected]
Juan Meng, 책임연구자
모집중
The First Affiliated Hospital of Chongqing Medical University - Respiratory, Chongqing, Sichuan, 400016, China
Yucheng Yang Principal Investigator, 연락처, 13452018123, [email protected]
Danyang Huang, 연락처, 023-89012224, [email protected]
Yucheng Yang, 책임연구자
모집중
Zhejiang
Zhejiang provincial people's hospital, Hangzhou, Zhejiang, 310014, China
Weiming Hu Principal Investigator, 연락처, 8613588426686, [email protected]
Di Zhao, 연락처, 0571-85893646, [email protected]
Weiming Hu, 책임연구자
모집중
The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics, Wenzhou, Zhejiang, 325027, China
Weixi Zhang Principal Investigator, 연락처, 13857724836, [email protected]
Ceyi Zhang, 연락처, 0577-85676486, [email protected]
Weixi Zhang, 책임연구자
모집중