Trial · NCT02443805

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

NCT02443805, Phase 3, Completed, Stallergenes Greer; results first posted 2019-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR. Trials, record NCT02443805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02443805

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
NCT number: NCT02443805
Status: Completed
Phases: Phase 3
Enrollment: 1,607 participants, actual
Lead sponsor: Stallergenes Greer
Conditions: Rhinitis, Allergic, Perennial, House Dust Mite Allergy
Interventions: 300 IR, Placebo
First posted: 2015-05-14
Last updated: 2019-10-14
Results first posted: 2019-09-25

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Combined Score	12 months	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.
Secondary	Average Rhinitis Total Symptom Score (RTSS)	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.
Secondary	Average Rescue Medication Score (RMS)	12 months	Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Combined Score	12 months	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.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Average Rhinitis Total Symptom Score (RTSS)	12 months	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.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Average Rescue Medication Score (RMS)	12 months	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.	Units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Combined Score	300 IR	3.62	95% Confidence Interval 3.33 to 3.92	Units on a scale
Total Combined Score	Placebo	4.35	95% Confidence Interval 4.06 to 4.66	Units on a scale
Average Rhinitis Total Symptom Score (RTSS)	300 IR	3.16	95% Confidence Interval 2.89 to 3.43	Units on a scale
Average Rhinitis Total Symptom Score (RTSS)	Placebo	3.79	95% Confidence Interval 3.53 to 4.07	Units on a scale
Average Rescue Medication Score (RMS)	300 IR	0.21	95% Confidence Interval 0.17 to 0.25	Units on a scale
Average Rescue Medication Score (RMS)	Placebo	0.30	95% Confidence Interval 0.26 to 0.35	Units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	300 IR	802
Overall Study	STARTED	Placebo	805
Overall Study	COMPLETED	300 IR	589
Overall Study	COMPLETED	Placebo	678
Overall Study	NOT COMPLETED	300 IR	213
Overall Study	NOT COMPLETED	Placebo	127

Source ClinicalTrials.gov

Adverse events86

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Oral pruritus	Gastrointestinal disorders	300 IR	189	800
other	Oral pruritus	Gastrointestinal disorders	Placebo	29	801
other	Oedema mouth	Gastrointestinal disorders	300 IR	112	800
other	Oedema mouth	Gastrointestinal disorders	Placebo	3	801
other	Tongue oedema	Gastrointestinal disorders	300 IR	68	800
other	Tongue oedema	Gastrointestinal disorders	Placebo	3	801
other	Lip oedema	Gastrointestinal disorders	300 IR	61	800
other	Lip oedema	Gastrointestinal disorders	Placebo	8	801
other	Dysphagia	Gastrointestinal disorders	300 IR	53	800
other	Dysphagia	Gastrointestinal disorders	Placebo	2	801

1 to 10 of 86Source ClinicalTrials.gov

See all 86 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	300 IR	0	800
Total, all-cause mortality	Placebo	0	801
Total, other adverse events	300 IR	424	800
Total, other adverse events	Placebo	223	801
Total, serious adverse events	300 IR	21	800
Total, serious adverse events	Placebo	9	801

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38225952	DERIVED	PubMed
39035788	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
300 IR vs Placebo: deaths from any cause	Trial comparisons
300 IR vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02443805

GET https://conductscience.org/api/trials/v1/NCT02443805/events?page=2

API reference For AI assistants