Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02596321 | A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma | PHASE3 | COMPLETED | 112 | — | — | Oct 1, 2015 | Jun 1, 2016 | Mar 1, 2018 | 9 | Belarus, Russia |
primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
| Arm | Type | Description |
|---|---|---|
| Mitizax ALK HDM tablet | EXPERIMENTAL | Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU) |
| Placebo tablet | PLACEBO_COMPARATOR | Placebo tablet |
| Name | Type | Description |
|---|---|---|
| Mitizax | DRUG | Allergen extract |
| Placebo | DRUG | Placebo tablet |
Inclusion Criteria: * Written informed consent obtained before entering the study * Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year * Use of sym...