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ALK-Abelló A/SA Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65 Fase III 300
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El ensayo clínico NCT07060885 está diseñado para estudiar el tratamiento de Rinoconjuntivitis Alérgica, Rinitis alérgica. Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 1 de septiembre de 2025, con el objetivo de reclutar a 300 participantes. Dirigido por ALK-Abelló A/S, se espera que finalice el 1 de agosto de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 31 de diciembre de 2025.
Resumen
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Descripción detallada
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...
Mostrar másTítulo oficial
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
Condiciones médicas
Rinoconjuntivitis AlérgicaRinitis alérgicaOtros ID del estudio
- MT-21
- 2025-000321-14 (Número EudraCT)
Número del NCT
Inicio del estudio (real)
2025-09-01
Última actualización
2025-12-31
Fecha de finalización (estimada)
2026-08
Inscripción (prevista)
300
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalActive 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 |
Comparador placeboPlacebo Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. | PLACEBO For daily administration (1 tablet per day) |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto, Adulto mayor
Edad mínima
12 Years
Criterios de sexo
Todos
- 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-Abelló A/S3 estudios activos para explorarContactos centrales del estudio
Contacto: Head of Clinical Project Management, +45 45747576, [email protected]
30 Centros del estudio en 1 países
Beijing Municipality
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, 100730, China
Chengshuo Wang Principal Investigator, Contacto, 13911623569, [email protected]
Yuyang Dai GCP Secretary, Contacto, 58268486-8011, [email protected]
Chengshuo Wang, Investigador principal
Reclutando
Fujian
Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China
Ting Chen Principal Investigator, Contacto, 059188216004, [email protected]
Jing Deng, Contacto, 0591-88216004, [email protected]
Ting Chen, Investigador principal
Reclutando
The first hospital affiliated Fujian medical University, Fuzhou, Fujian, 350005, China
Yuanteng Xu Principal Investigator, Contacto, 059187981262, [email protected]
Anpeng Wu, Contacto, 0591-87981262, [email protected]
Yuanteng Xu, Investigador principal
Reclutando
Guangdong
The first affiliated hospital of guangzhou medical university-respiratory department, Guangzhou, Guangdong, 510120, China
Jing Li Principal Investigator, Contacto, 18928868259, [email protected]
Gesi Wen, Contacto, 15914303910, [email protected]
Jing Li, Investigador principal
Reclutando
The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510630, China
Qintai Yang Principal Investigator, Contacto, 13724859848, [email protected]
Denglai Liu, Contacto, 020-85253153, [email protected]
Qintai Yang, Investigador principal
Reclutando
The Third Affilliated Hospital of Southern Medical University, Guangzhou, Guangdong, 510630, China
Guangyong Tian Principal Investigator, Contacto, 13430359092, [email protected]
Xiangfei Song, Contacto, 020-62784066, [email protected]
Guangyong Tian, Investigador principal
Reclutando
Shenzhen Children's Hospital - Respiratory, Shenzhen, Guangdong, 518026, China
Yuejie Zheng Principal Investigator, Contacto, 8618938690506, [email protected]
Jiapeng He 何家朋 GCP office secretary, Contacto, 0755-83008184, [email protected]
Yuejie Zheng, Investigador principal
Reclutando
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology, Shenzhen, Guangdong, 518052, China
Liang Chen Principal Investigator, Contacto, 8618898589170, [email protected]
Jingfeng Qin GCP Secretary, Contacto, 0755-26553111, [email protected]
Liang Chen, Investigador principal
Reclutando
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital, Zhuhai, Guangdong, 510275, China
Haiyu Hong Principal Investigator, Contacto, 13823070089, [email protected]
Ming Ye 叶明 GCP office secretary, Contacto, 0756-2528188, [email protected]
Haiyu Hong, Investigador principal
Reclutando
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Guangyao He Principal Investigator, Contacto, 7715356566, [email protected]
Ni Liu, Contacto, 0771-5309187, [email protected]
Guangyao He, Investigador principal
Reclutando
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology, Nanning, Guangxi, 530021, China
Shenhong Qu Principal Investigator, Contacto, 8607712186318, [email protected]
Bi Deng, Contacto, 0771-2186742, [email protected]
Shenhong Qu, Investigador principal
Reclutando
Hainan
Hainan General Hospital - Respiratory, Haikou, Hainan, 570311, China
Xin Wei Principal Investigator, Contacto, 13016296267, [email protected]
Haiyu Xue GCP Secretary, Contacto, 13976989559, [email protected]
Xin Wei, Investigador principal
Reclutando
Henan
The Third Hospital of Changsha - Pulmonology, Changshacun, Henan, 410015, China
Ming Yang Principal Investigator, Contacto, 13017280697, [email protected]
Zhiya Hu 胡智雅 GCP office secretary, Contacto, 0731-85171463/ 1524307708, [email protected]
Ming Yang, Investigador principal
Reclutando
The First Affiliated Hospital of University of South China - Endocrinology, Hengyang, Henan, 421001, China
Qingshan Jiang Principal Investigator, Contacto, 07348312320, [email protected]
Pengju Ye，Juan Wen, Contacto, 0734-8578930, 0734-8578934, [email protected]
Qingshan Jiang, Investigador principal
Reclutando
Hubei
Jingzhou Central Hospital - Otorhinolaryngology, Jingzhou, Hubei, 434020, China
Lijia Wan Principal Investigator, Contacto, 18972160068, [email protected]
Zhen Xu, Contacto, 0716- 8487552, [email protected]
Lijia Wan, Investigador principal
Reclutando
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology, Wuhan, Hubei, 430022, China
Jianjun Chen Principal Investigator, Contacto, 13659851719, [email protected]
Li Zhang, Contacto, 13026327780, [email protected]
Jianjun Chen, Investigador principal
Reclutando
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, 430030, China
RongFei Zhu Principal Investigator, Contacto, + 8600000000, [email protected]
Han Bai, Contacto, 027-83662379, [email protected]
RongFei Zhu, Investigador principal
Reclutando
Jiangsu
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology, Nanjing, Jiangsu, 210029, China
Lei Cheng Principal Investigator, Contacto, + 8600000000, [email protected]
Peipei Shi, Contacto, 025-68306156, [email protected]
Lei Cheng, Investigador principal
Reclutando
The First Affiliated Hospital of Soochow University - Respiratory, Suzhou, Jiangsu, 215006, China
YaFeng Yu Principal Investigator, Contacto, 51265223637, [email protected]
Ju Qian, Contacto, 0512-67972858, [email protected]
YaFeng Yu, Investigador principal
Reclutando
Jiangxi
Nanchang University - The First Affiliated Hospital, Nanchang, Jiangxi, 330046, China
Jing Ye Principal Investigator, Contacto, 13979161109, [email protected]
Duanwen Cao, Contacto, 0791-8869 5125, [email protected]
Jing Ye, Investigador principal
Reclutando
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330047, China
Hongbing Liu Principal Investigator, Contacto, 13007452129, [email protected]
Zhao Yuan袁钊 GCP office secretary, Contacto, 0791-86300985, [email protected]
Hongbing Liu, Investigador principal
Reclutando
Shaanxi
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology, Xi'an, Shaanxi, 710004, China
Kang Zhu Principal Investigator, Contacto, 15829292533, [email protected]
Yang Zhao, Contacto, 15129006956, [email protected]
Kang Zhu, Investigador principal
Reclutando
Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
Wei Tang Principal Investigator, Contacto, 18917080579, [email protected]
Jiajie Wu, Contacto, 021-64370045, [email protected]
Wei Tang, Investigador principal
Reclutando
Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
Mei ling Principal Investigator, Contacto, + 8600000000, [email protected]
Contacto, 021-31587861, [email protected]
Mei ling, Investigador principal
Reclutando
Sichuan
Peking Union Medical College Hospital, Beijing, Sichuan, 100730, China
Kai Guan Principal Investigator, Contacto, 8613611113032, [email protected]
Chi Zhang, Contacto, 010-69154116, [email protected]
Kai Guan, Investigador principal
Reclutando
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital), Chengdu, Sichuan, 610017, China
Ping Wei Principal Investigator, Contacto, 13647684008, [email protected]
Weiyi Guo, Contacto, 028-85503776, [email protected]
Ping Wei, Investigador principal
Reclutando
West China Hospital of Sichuan University - Otorhinolaryngology, Chengdu, Sichuan, 610041, China
Juan Meng Principal Investigator, Contacto, 85422114, [email protected]
Hao Xiao, Contacto, 18227603630, [email protected]
Juan Meng, Investigador principal
Reclutando
The First Affiliated Hospital of Chongqing Medical University - Respiratory, Chongqing, Sichuan, 400016, China
Yucheng Yang Principal Investigator, Contacto, 13452018123, [email protected]
Danyang Huang, Contacto, 023-89012224, [email protected]
Yucheng Yang, Investigador principal
Reclutando
Zhejiang
Zhejiang provincial people's hospital, Hangzhou, Zhejiang, 310014, China
Weiming Hu Principal Investigator, Contacto, 8613588426686, [email protected]
Di Zhao, Contacto, 0571-85893646, [email protected]
Weiming Hu, Investigador principal
Reclutando
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, Contacto, 13857724836, [email protected]
Ceyi Zhang, Contacto, 0577-85676486, [email protected]
Weixi Zhang, Investigador principal
Reclutando