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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04502966 | Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction | PHASE2 | COMPLETED | 199 | — | — | Nov 5, 2020 | Feb 20, 2025 | Apr 27, 2026 | 1 | United Kingdom |
NAC (TNSS Area-under-Curve \[AUC 0-1hr\]), comparing the TNSS AUC 0-1 hr between the referenced treatment arms: a clinical tolerance outcome measure at Year 3, one year after completion of treatment. The Total Nasal Symptom Score (TNSS) is a participant-reported composite symptom assessment of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each scored on a scale from 0 to 3 where 0 = none, 3 = severe. TNSS total score is calculated as the sum of the response for all 4 individual nasal symptom scores and can range from a minimum score of 0 to a maximum score of 12: a higher score indicates more severe symptoms. The primary treatment comparison is between SLIT/Dupilumab and Double-Placebo.
| Arm | Type | Description |
|---|---|---|
| Grazax® +Dupixent® | EXPERIMENTAL | Participants randomized to this assignment will receive the following during the initial 2-year period of the trial: * Once daily tablet of Grazax® sublingual immunotherapy and * Dupixent® administered every other week (e.g., biweekly) by subcutaneous injection |
| Grazax® + Dupixent® Placebo | EXPERIMENTAL | Participants randomized to this assignment will receive the following during the initial 2-year period of the trial: * Once daily tablet of Grazax® sublingual immunotherapy and * Placebo for Dupixent® administered every other week (e.g., biweekly) by subcutaneous injection |
| Grazax® Placebo +Dupixent® Placebo | PLACEBO_COMPARATOR | Participants randomized to this assignment will receive the following during the initial 2-year period of the trial: * Once daily tablet of placebo for Grazax® sublingual immunotherapy and * Placebo for Dupixent® administered every other week (e.g., biweekly) by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Dupixent® | BIOLOGICAL | An initial dose of 600 mg (two 300 mg injections), followed by 300 mg administered every other week (biweekly), by subcutaneous injection. |
| Grazax® | BIOLOGICAL | One Grazax® tablet daily, by sublingual administration. Grazax® is formulated as a freeze-dried oral lyophilisate/orally disintegrating tablet for oromucosal use. The active pharmaceutical ingredient is a standardized allergen extract derived from extraction and purification of grass pollen from timothy grass (Phleum pratense). The biological activity of the allergen is expressed in Standardized Quality Tablet units (SQ-T) units. The Grazax® dosage is one oral lyophilisate (75,000 Standardized Quality Tablet units (SQ-T) or approximately 2800 Bioequivalent allergy units (BAU), a measure of Phleum pratense SQ total biological potency defined by the FDA. |
| Dupixent® Placebo | DRUG | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose followed by a single injection administered every other week. Dupixent® placebo is a subcutaneous injection whose composition is identical to the active Dupixent®, with the exception of the active pharmaceutical ingredient. |
| Grazax® Placebo | DRUG | One tablet of Placebo (for Grazax®) daily, by sublingual administration. Grazax® placebo is a tablet whose composition is identical to the active Grazax® tablet with the only exception being exclusion of the active pharmaceutical ingredient, Phleum pratense Standardized Quality Tablet (SQ-T) units. |
Inclusion Criteria: * Participant must be able to understand and provide informed consent * A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years, with peak symptoms in May, June, or July * A clinical history of moderate to severe rhinoconjunctivitis symptoms ...