Trial Outcomes & Findings for Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR (NCT NCT02443805)

Last Updated: 2019-10-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1607 participants

Primary outcome timeframe

12 months

Results posted on

2019-10-14

Participant Flow

This study was conducted between 29 September 2015 (first patient, first visit) and 25 June 2018 (last patient, last visit).

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.

Participant milestones

Participant milestones
Measure	300 IR 300 IR tablet of HDM Allergen Extracts	Placebo Placebo tablet
Overall Study STARTED	802	805
Overall Study COMPLETED	589	678
Overall Study NOT COMPLETED	213	127

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR tablet of HDM Allergen Extracts	Placebo Placebo tablet
Overall Study Adverse Event	100	18
Overall Study Withdrawal by Subject	73	74
Overall Study Lost to Follow-up	19	14
Overall Study Pregnancy	6	5
Overall Study Protocol Violation	2	4
Overall Study Lack of Efficacy	1	1
Overall Study Non-compliance with study drug	6	4
Overall Study Withdrawal by parent/guardian	3	5
Overall Study Any other reason not above-mentioned	3	2

Baseline Characteristics

Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=711 Participants 300 IR tablet of HDM Allergen Extracts	Placebo n=765 Participants Placebo tablet	Total n=1476 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 13.07 • n=5 Participants	29.6 years STANDARD_DEVIATION 12.58 • n=7 Participants	29.6 years STANDARD_DEVIATION 12.81 • n=5 Participants
Sex: Female, Male Female	360 Participants n=5 Participants	396 Participants n=7 Participants	756 Participants n=5 Participants
Sex: Female, Male Male	351 Participants n=5 Participants	369 Participants n=7 Participants	720 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	660 Participants n=5 Participants	719 Participants n=7 Participants	1379 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	37 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) White	660 Participants n=5 Participants	701 Participants n=7 Participants	1361 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment North America	212 participants n=5 Participants	240 participants n=7 Participants	452 participants n=5 Participants
Region of Enrollment Europe	453 participants n=5 Participants	477 participants n=7 Participants	930 participants n=5 Participants
Region of Enrollment Israel	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Region of Enrollment Russia	23 participants n=5 Participants	25 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	300 IR n=586 Participants 300 IR tablet of HDM Allergen Extracts	Placebo n=676 Participants Placebo tablet
Total Combined Score	3.62 Units on a scale Interval 3.33 to 3.92	4.35 Units on a scale Interval 4.06 to 4.66

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	300 IR n=586 Participants 300 IR tablet of HDM Allergen Extracts	Placebo n=676 Participants Placebo tablet
Average Rhinitis Total Symptom Score (RTSS)	3.16 Units on a scale Interval 2.89 to 3.43	3.79 Units on a scale Interval 3.53 to 4.07

SECONDARY outcome

Timeframe: 12 months

Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.

Outcome measures

Outcome measures
Measure	300 IR n=586 Participants 300 IR tablet of HDM Allergen Extracts	Placebo n=676 Participants Placebo tablet
Average Rescue Medication Score (RMS)	0.21 Units on a scale Interval 0.17 to 0.25	0.30 Units on a scale Interval 0.26 to 0.35

Adverse Events

300 IR

Serious events: 21 serious events

Other events: 424 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 223 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	300 IR n=800 participants at risk 300 IR tablet of HDM Allergen Extracts	Placebo n=801 participants at risk Placebo tablet
Gastrointestinal disorders Oral pruritus	23.6% 189/800 • 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.	3.6% 29/801 • 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.
Gastrointestinal disorders Oedema mouth	14.0% 112/800 • 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.	0.37% 3/801 • 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.
Gastrointestinal disorders Tongue oedema	8.5% 68/800 • 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.	0.37% 3/801 • 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.
Gastrointestinal disorders Lip oedema	7.6% 61/800 • 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.	1.00% 8/801 • 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.
Gastrointestinal disorders Dysphagia	6.6% 53/800 • 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.	0.25% 2/801 • 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.
Gastrointestinal disorders Nausea	5.9% 47/800 • 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.	1.00% 8/801 • 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.
Gastrointestinal disorders Abdominal pain upper	5.4% 43/800 • 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.	1.5% 12/801 • 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.
Infections and infestations Nasopharyngitis	13.4% 107/800 • 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.	14.6% 117/801 • 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.
Respiratory, thoracic and mediastinal disorders Throat irritation	17.0% 136/800 • 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.	3.4% 27/801 • 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.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	5.8% 46/800 • 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.	0.12% 1/801 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 45/800 • 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.	3.9% 31/801 • 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.
Ear and labyrinth disorders Ear pruritus	14.4% 115/800 • 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.	1.6% 13/801 • 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.
Nervous system disorders Headache	7.1% 57/800 • 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.	8.5% 68/801 • 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.

Additional Information

Martine Le Gall, Director of Clinical Development

Stallergenes Greer

Phone: +33 1 55 59 25 56

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place