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A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

NCT07060885

Active Not RecruitingPhase 3

Sponsor: ALK-Abelló A/S

Conditions: Allergic Rhinoconjunctivitis, Allergic Rhinitis

Interventions: HDM SLIT-tablet (12 SQ-HDM), Placebo

Countries: China

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (30)

Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Shenzhen, Guangdong, China
Zhuhai, Guangdong, China
Nanning, Guangxi, China
Nanning, Guangxi, China
Haikou, Hainan, China
Changshacun, Henan, China
Hengyang, Henan, China
Jingzhou, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Xi'an, Shaanxi, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Beijing, Sichuan, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Chongqing, Sichuan, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China