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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.
This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year.
The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 IR | Active Comparator | 300 IR tablet of HDM Allergen Extracts |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 IR | Biological | 300 IR tablet of HDM Allergen Extracts |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Combined Score | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Rhinitis Total Symptom Score (RTSS) | 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. | 12 months |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Demoly, MD | CHU Arnaud de Villeneuve, Montpellier, France | Principal Investigator |
| Tom Casale, MD | University of South of Florida, Tampa, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South of Florida | Tampa | Florida | 33610 | United States | ||
| CHU Arnaud de Villeneuve |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39035788 | Derived | Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul. | |
| 38225952 | Derived |
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2,174 (50.9%) and 486 (11.4%) patients were excluded before and during the placebo run-in period, respectively. The main reason for screen failures at these two stages was a failure to meet randomization criteria.
This study was conducted between 29 September 2015 (first patient, first visit) and 25 June 2018 (last patient, last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 IR | 300 IR tablet of HDM Allergen Extracts |
| FG001 | Placebo | Placebo tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) included all randomized patients who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 IR | 300 IR tablet of HDM Allergen Extracts |
| BG001 | Placebo | Placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Combined Score | 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. | The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the primary analysis: 1,262 pts. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | 12 months |
|
12 months
Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
1,607 patients were randomized. 6 patients randomized by mistake did not receive any IP of the treatment period and were excluded from the Safety Set.
Accordingly, the Safety Set comprised 1,601 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 IR | 300 IR tablet of HDM Allergen Extracts | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral pruritus | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martine Le Gall, Director of Clinical Development | Stallergenes Greer | +33 1 55 59 25 56 | martine.legall@stallergenesgreer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2017 | Aug 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2018 | Aug 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo |
| Biological |
Placebo tablet |
|
| Average Rescue Medication Score (RMS) | Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better. | 12 months |
| Montpellier |
| 34295 |
| France |
| Pfaar O, De Blay F, Canonica GW, Casale TB, Gevaert P, Hellings PW, Kowal K, Passalacqua G, Tortajada-Girbes M, Vidal C, Worm M, Bahbah F, Demoly P. Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial. World Allergy Organ J. 2023 Dec 22;17(1):100849. doi: 10.1016/j.waojou.2023.100849. eCollection 2024 Jan. |
| Lost to Follow-up |
|
| Pregnancy |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Non-compliance with study drug |
|
| Withdrawal by parent/guardian |
|
| Any other reason not above-mentioned |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo tablet |
|
|
|
| Secondary | Average Rhinitis Total Symptom Score (RTSS) | 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. | The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | 12 months |
|
|
|
| Secondary | Average Rescue Medication Score (RMS) | Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better. | The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | 12 months |
|
|
|
| 800 |
| 21 |
| 800 |
| 424 |
| 800 |
| EG001 | Placebo | Placebo tablet | 0 | 801 | 9 | 801 | 223 | 801 |
| Tick-borne viral encephalitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Plica syndrome | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chronic fatigue syndrome | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oedema mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tongue oedema | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |