A Phase 3 interventional study of HDM SLIT-tablet (12 SQ-HDM) and Placebo in Allergic Rhinoconjunctivitis and Allergic Rhinitis, sponsored by ALK-Abelló A/S. Completed at 30 sites in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
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 conducted in China. The treatment period will be 24-28 weeks.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's enrollment of 327 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →ALK-Abelló A/S is the lead sponsor of 67 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Biological: HDM SLIT-tablet (12 SQ-HDM)
Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Other: Placebo
For daily administration (1 tablet per day) Other Names: Acarizax, Odactra
For daily administration (1 tablet per day)
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 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.
Time frame: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.
Plan to share: No
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Ran from Sep 2025 to primary completion in Aug 2026, 11 months.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's 11 months is close to that.
Counting every sponsor, half of 41 studies reached it within 13 months; a quarter within 6 and three quarters within 35.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2026, on Oct 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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