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Die klinische Studie NCT07060885 für Allergische Rhinokonjunktivitis, Allergische Rhinitis ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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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 Phase 3 300
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07060885 untersucht Behandlung im Zusammenhang mit Allergische Rhinokonjunktivitis, Allergische Rhinitis. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 1. September 2025. Es ist geplant, 300 Teilnehmer aufzunehmen. Durchgeführt von ALK-Abelló A/S wird der Abschluss für 1. August 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 31. Dezember 2025 aktualisiert.
Kurzbeschreibung
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Ausführliche Beschreibung
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...
Mehr anzeigenOffizieller Titel
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
Erkrankungen
Allergische RhinokonjunktivitisAllergische RhinitisWeitere Studien-IDs
- MT-21
- 2025-000321-14 (EudraCT-Nummer)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-09-01
Zuletzt aktualisiert
2025-12-31
Studienende (vorauss.)
2026-08
Geplante Rekrutierung
300
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellActive 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 |
Placebo-VergleichspräparatPlacebo Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. | PLACEBO For daily administration (1 tablet per day) |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
12 Years
Zugelassene Geschlechter
Alle
- 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 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Head of Clinical Project Management, +45 45747576, [email protected]
30 Studienstandorte in 1 Ländern
Beijing Municipality
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, 100730, China
Chengshuo Wang Principal Investigator, Kontakt, 13911623569, [email protected]
Yuyang Dai GCP Secretary, Kontakt, 58268486-8011, [email protected]
Chengshuo Wang, Hauptprüfer
Offene Rekrutierung
Fujian
Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China
Ting Chen Principal Investigator, Kontakt, 059188216004, [email protected]
Jing Deng, Kontakt, 0591-88216004, [email protected]
Ting Chen, Hauptprüfer
Offene Rekrutierung
The first hospital affiliated Fujian medical University, Fuzhou, Fujian, 350005, China
Yuanteng Xu Principal Investigator, Kontakt, 059187981262, [email protected]
Anpeng Wu, Kontakt, 0591-87981262, [email protected]
Yuanteng Xu, Hauptprüfer
Offene Rekrutierung
Guangdong
The first affiliated hospital of guangzhou medical university-respiratory department, Guangzhou, Guangdong, 510120, China
Jing Li Principal Investigator, Kontakt, 18928868259, [email protected]
Gesi Wen, Kontakt, 15914303910, [email protected]
Jing Li, Hauptprüfer
Offene Rekrutierung
The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510630, China
Qintai Yang Principal Investigator, Kontakt, 13724859848, [email protected]
Denglai Liu, Kontakt, 020-85253153, [email protected]
Qintai Yang, Hauptprüfer
Offene Rekrutierung
The Third Affilliated Hospital of Southern Medical University, Guangzhou, Guangdong, 510630, China
Guangyong Tian Principal Investigator, Kontakt, 13430359092, [email protected]
Xiangfei Song, Kontakt, 020-62784066, [email protected]
Guangyong Tian, Hauptprüfer
Offene Rekrutierung
Shenzhen Children's Hospital - Respiratory, Shenzhen, Guangdong, 518026, China
Yuejie Zheng Principal Investigator, Kontakt, 8618938690506, [email protected]
Jiapeng He 何家朋 GCP office secretary, Kontakt, 0755-83008184, [email protected]
Yuejie Zheng, Hauptprüfer
Offene Rekrutierung
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology, Shenzhen, Guangdong, 518052, China
Liang Chen Principal Investigator, Kontakt, 8618898589170, [email protected]
Jingfeng Qin GCP Secretary, Kontakt, 0755-26553111, [email protected]
Liang Chen, Hauptprüfer
Offene Rekrutierung
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital, Zhuhai, Guangdong, 510275, China
Haiyu Hong Principal Investigator, Kontakt, 13823070089, [email protected]
Ming Ye 叶明 GCP office secretary, Kontakt, 0756-2528188, [email protected]
Haiyu Hong, Hauptprüfer
Offene Rekrutierung
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Guangyao He Principal Investigator, Kontakt, 7715356566, [email protected]
Ni Liu, Kontakt, 0771-5309187, [email protected]
Guangyao He, Hauptprüfer
Offene Rekrutierung
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology, Nanning, Guangxi, 530021, China
Shenhong Qu Principal Investigator, Kontakt, 8607712186318, [email protected]
Bi Deng, Kontakt, 0771-2186742, [email protected]
Shenhong Qu, Hauptprüfer
Offene Rekrutierung
Hainan
Hainan General Hospital - Respiratory, Haikou, Hainan, 570311, China
Xin Wei Principal Investigator, Kontakt, 13016296267, [email protected]
Haiyu Xue GCP Secretary, Kontakt, 13976989559, [email protected]
Xin Wei, Hauptprüfer
Offene Rekrutierung
Henan
The Third Hospital of Changsha - Pulmonology, Changshacun, Henan, 410015, China
Ming Yang Principal Investigator, Kontakt, 13017280697, [email protected]
Zhiya Hu 胡智雅 GCP office secretary, Kontakt, 0731-85171463/ 1524307708, [email protected]
Ming Yang, Hauptprüfer
Offene Rekrutierung
The First Affiliated Hospital of University of South China - Endocrinology, Hengyang, Henan, 421001, China
Qingshan Jiang Principal Investigator, Kontakt, 07348312320, [email protected]
Pengju Ye，Juan Wen, Kontakt, 0734-8578930, 0734-8578934, [email protected]
Qingshan Jiang, Hauptprüfer
Offene Rekrutierung
Hubei
Jingzhou Central Hospital - Otorhinolaryngology, Jingzhou, Hubei, 434020, China
Lijia Wan Principal Investigator, Kontakt, 18972160068, [email protected]
Zhen Xu, Kontakt, 0716- 8487552, [email protected]
Lijia Wan, Hauptprüfer
Offene Rekrutierung
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology, Wuhan, Hubei, 430022, China
Jianjun Chen Principal Investigator, Kontakt, 13659851719, [email protected]
Li Zhang, Kontakt, 13026327780, [email protected]
Jianjun Chen, Hauptprüfer
Offene Rekrutierung
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, 430030, China
RongFei Zhu Principal Investigator, Kontakt, + 8600000000, [email protected]
Han Bai, Kontakt, 027-83662379, [email protected]
RongFei Zhu, Hauptprüfer
Offene Rekrutierung
Jiangsu
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology, Nanjing, Jiangsu, 210029, China
Lei Cheng Principal Investigator, Kontakt, + 8600000000, [email protected]
Peipei Shi, Kontakt, 025-68306156, [email protected]
Lei Cheng, Hauptprüfer
Offene Rekrutierung
The First Affiliated Hospital of Soochow University - Respiratory, Suzhou, Jiangsu, 215006, China
YaFeng Yu Principal Investigator, Kontakt, 51265223637, [email protected]
Ju Qian, Kontakt, 0512-67972858, [email protected]
YaFeng Yu, Hauptprüfer
Offene Rekrutierung
Jiangxi
Nanchang University - The First Affiliated Hospital, Nanchang, Jiangxi, 330046, China
Jing Ye Principal Investigator, Kontakt, 13979161109, [email protected]
Duanwen Cao, Kontakt, 0791-8869 5125, [email protected]
Jing Ye, Hauptprüfer
Offene Rekrutierung
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330047, China
Hongbing Liu Principal Investigator, Kontakt, 13007452129, [email protected]
Zhao Yuan袁钊 GCP office secretary, Kontakt, 0791-86300985, [email protected]
Hongbing Liu, Hauptprüfer
Offene Rekrutierung
Shaanxi
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology, Xi'an, Shaanxi, 710004, China
Kang Zhu Principal Investigator, Kontakt, 15829292533, [email protected]
Yang Zhao, Kontakt, 15129006956, [email protected]
Kang Zhu, Hauptprüfer
Offene Rekrutierung
Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
Wei Tang Principal Investigator, Kontakt, 18917080579, [email protected]
Jiajie Wu, Kontakt, 021-64370045, [email protected]
Wei Tang, Hauptprüfer
Offene Rekrutierung
Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
Mei ling Principal Investigator, Kontakt, + 8600000000, [email protected]
Kontakt, 021-31587861, [email protected]
Mei ling, Hauptprüfer
Offene Rekrutierung
Sichuan
Peking Union Medical College Hospital, Beijing, Sichuan, 100730, China
Kai Guan Principal Investigator, Kontakt, 8613611113032, [email protected]
Chi Zhang, Kontakt, 010-69154116, [email protected]
Kai Guan, Hauptprüfer
Offene Rekrutierung
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital), Chengdu, Sichuan, 610017, China
Ping Wei Principal Investigator, Kontakt, 13647684008, [email protected]
Weiyi Guo, Kontakt, 028-85503776, [email protected]
Ping Wei, Hauptprüfer
Offene Rekrutierung
West China Hospital of Sichuan University - Otorhinolaryngology, Chengdu, Sichuan, 610041, China
Juan Meng Principal Investigator, Kontakt, 85422114, [email protected]
Hao Xiao, Kontakt, 18227603630, [email protected]
Juan Meng, Hauptprüfer
Offene Rekrutierung
The First Affiliated Hospital of Chongqing Medical University - Respiratory, Chongqing, Sichuan, 400016, China
Yucheng Yang Principal Investigator, Kontakt, 13452018123, [email protected]
Danyang Huang, Kontakt, 023-89012224, [email protected]
Yucheng Yang, Hauptprüfer
Offene Rekrutierung
Zhejiang
Zhejiang provincial people's hospital, Hangzhou, Zhejiang, 310014, China
Weiming Hu Principal Investigator, Kontakt, 8613588426686, [email protected]
Di Zhao, Kontakt, 0571-85893646, [email protected]
Weiming Hu, Hauptprüfer
Offene Rekrutierung
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, Kontakt, 13857724836, [email protected]
Ceyi Zhang, Kontakt, 0577-85676486, [email protected]
Weixi Zhang, Hauptprüfer
Offene Rekrutierung