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Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Phase 3 trial testing 300 IR in Rhinitis, Allergic, Perennial in 1,607 participants. Completed in 25 June 2018.
| Lead sponsor | Stallergenes Greer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,607 |
| Start date | 29 September 2015 |
| Primary completion | 25 June 2018 |
| Estimated completion | 25 June 2018 |
| Sites | 2 locations across France, United States |
Stallergenes Greer — full company profile →
Adults 12 to 65, any sex, with Rhinitis, Allergic, Perennial or House Dust Mite Allergy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.
| Group | Value | 95% CI |
|---|---|---|
| 300 IR | 3.62 | 3.33 – 3.92 |
| Placebo | 4.35 | 4.06 – 4.66 |
Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12. Lower is better.
| Group | Value | 95% CI |
|---|---|---|
| 300 IR | 3.16 | 2.89 – 3.43 |
| Placebo | 3.79 | 3.53 – 4.07 |
Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.
| Group | Value | 95% CI |
|---|---|---|
| 300 IR | 0.21 | 0.17 – 0.25 |
| Placebo | 0.30 | 0.26 – 0.35 |
Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 300 IR | Placebo |
|---|---|---|---|
| Appendicitis | Infections and infestations | — | — |
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — |
| Tick-borne viral encephalitis | Infections and infestations | — | — |
| Tonsillitis | Infections and infestations | — | — |
| Cellulitis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — |
| Joint dislocation | Injury, poisoning and procedural complications | — | — |
| Pelvic fracture | Injury, poisoning and procedural complications | — | — |
| Spinal fracture | Injury, poisoning and procedural complications | — | — |
| Chondromalacia | Musculoskeletal and connective tissue disorders | — | — |
| Plica syndrome | Musculoskeletal and connective tissue disorders | — | — |
| Chest pain | General disorders | — | — |
| Chronic fatigue syndrome | General disorders | — | — |
| Renal colic | Renal and urinary disorders | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Reaction | System | 300 IR | Placebo |
|---|---|---|---|
| Oral pruritus | Gastrointestinal disorders | — | — |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Ear pruritus | Ear and labyrinth disorders | — | — |
| Oedema mouth | Gastrointestinal disorders | — | — |
| Tongue oedema | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Lip oedema | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Appendicitis, Pharyngeal disorder, Dermatitis atopic, Tick-borne viral encephalitis, Tonsillitis, Cellulitis, Pneumonia, Breast cancer.
Data from ClinicalTrials.gov NCT02443805 adverse events section.
The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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