Trial · NCT03237325

DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

NCT03237325, Phase 3, Completed, Soligenix; results first posted 2022-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer. Trials, record NCT03237325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03237325

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Trial

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

Title: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
NCT number: NCT03237325
Status: Completed
Phases: Phase 3
Enrollment: 266 participants, actual
Lead sponsor: Soligenix
Conditions: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
Interventions: SGX942, Placebo
First posted: 2017-08-02
Last updated: 2022-11-08
Results first posted: 2022-08-29

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Duration of Severe Oral Mucositis (SOM)	approx. 13 weeks	To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Duration of Severe Oral Mucositis (SOM)	approx. 13 weeks	The analysis population was defined as all participants receiving a minimum of 55 Gray of cumulative radiation.	days	MEDIAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Duration of Severe Oral Mucositis (SOM)	SGX942		12.5	95% Confidence Interval 4.0 to 22.0	days
Duration of Severe Oral Mucositis (SOM)	Placebo		20.0	95% Confidence Interval 12.0 to 29.0	days

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SGX942	127
Overall Study	STARTED	Placebo	139
Overall Study	COMPLETED	SGX942	112
Overall Study	COMPLETED	Placebo	114
Overall Study	NOT COMPLETED	SGX942	15
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events228

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	Anaemia	Blood and lymphatic system disorders	SGX942	20	127
other	Anaemia	Blood and lymphatic system disorders	Placebo	31	139
other	Neutropenia	Blood and lymphatic system disorders	SGX942	21	127
other	Neutropenia	Blood and lymphatic system disorders	Placebo	16	139
other	Deafness	Ear and labyrinth disorders	SGX942	8	127
other	Deafness	Ear and labyrinth disorders	Placebo	7	139
other	Hypoacusis	Ear and labyrinth disorders	SGX942	7	127
other	Hypoacusis	Ear and labyrinth disorders	Placebo	8	139
other	Tinnitus	Ear and labyrinth disorders	SGX942	29	127
other	Tinnitus	Ear and labyrinth disorders	Placebo	37	139

1 to 10 of 228Source ClinicalTrials.gov

See all 228 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SGX942	7	127
Total, all-cause mortality	Placebo	9	139
Total, other adverse events	SGX942	123	127
Total, other adverse events	Placebo	135	139
Total, serious adverse events	SGX942	74	127
Total, serious adverse events	Placebo	64	139

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27015977	BACKGROUND	PubMed
27746305	BACKGROUND	PubMed
28649557	BACKGROUND	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
SGX942 vs Placebo: deaths from any cause	Trial comparisons
SGX942 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/NCT03237325

GET https://conductscience.org/api/trials/v1/NCT03237325/events?page=2

API reference For AI assistants