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

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ClinicalTrials.gov Identifier: NCT03237325

Recruitment Status : Completed

First Posted : August 2, 2017

Results First Posted : August 29, 2022

Last Update Posted : November 8, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Soligenix

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Oral Mucositis
Interventions	Drug: SGX942 Drug: Placebo
Enrollment	266

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	SGX942	Placebo
Arm/Group Description	Patients are randomized 1:1 active/...	Patients are randomized 1:1 active/...
Arm/Group Description	Patients are randomized 1:1 active/placebo. SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.	Patients are randomized 1:1 active/placebo. Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Period Title: Overall Study
Started	127	139
Completed	112	114
Not Completed	15	25
Reason Not Completed
Lost to Follow-up	3	5
Physician Decision	2	4
Withdrawal by Subject	9	12
Noncompliance with Study Procedures	1	1
Termination by Sponsor	0	1
Reason other than described	0	2

Baseline Characteristics

Arm/Group Title		SGX942	Placebo	Total
Arm/Group Description		Patients are randomized 1:1 active/...	Patients are randomized 1:1 active/...	Total of all reporting groups
Arm/Group Description		Patients are randomized 1:1 active/placebo. SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.	Patients are randomized 1:1 active/placebo. Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.	Total of all reporting groups
Overall Number of Baseline Participants		127	139	266
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX942 or Placebo)
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	127 participants	139 participants	266 participants
		57.2 (7.48)	58.8 (8.74)	58.1 (8.19)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	127 participants	139 participants	266 participants
	Female	22 17.3%	28 20.1%	50 18.8%
	Male	105 82.7%	111 79.9%	216 81.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	127 participants	139 participants	266 participants
	Hispanic or Latino	9 7.1%	15 10.8%	24 9.0%
	Not Hispanic or Latino	105 82.7%	113 81.3%	218 82.0%
	Unknown or Not Reported	13 10.2%	11 7.9%	24 9.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	127 participants	139 participants	266 participants
	American Indian or Alaska Native	2 1.6%	1 0.7%	3 1.1%
	Asian	1 0.8%	3 2.2%	4 1.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	5 3.9%	6 4.3%	11 4.1%
	White	118 92.9%	128 92.1%	246 92.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 0.8%	1 0.7%	2 0.8%
HPV Status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	127 participants	139 participants	266 participants
	Positive	93 73.2%	92 66.2%	185 69.5%
	Negative	34 26.8%	47 33.8%	81 30.5%

Outcome Measures

1.Primary Outcome


Title	Duration of Severe Oral Mucositis (SOM)
Description	To assess the efficacy of SGX942 compared to placebo in decreasing the...
Description	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.
Time Frame	approx. 13 weeks

Outcome Measure Data

Analysis Population Description

The analysis population was defined as all participants receiving a minimum of 55 Gray of cumulative radiation.


Arm/Group Title	SGX942	Placebo
Arm/Group Description:	Patients are randomized 1:1 active/...	Patients are randomized 1:1 active/...
Arm/Group Description:	Patients are randomized 1:1 active/placebo. SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.	Patients are randomized 1:1 active/placebo. Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Overall Number of Participants Analyzed	118	130
Median (95% Confidence Interval) Unit of Measure: days
	12.5 (4.0 to 22.0)	20.0 (12.0 to 29.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SGX942, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1798
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Adverse Events

Time Frame	Adverse event (AE) data was collected between randomization through 6 weeks after radiation therapy treatment ended. Participants received up to 7 weeks of radiation, for a maximum AE collection time of 13 weeks.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	SGX942	Placebo
Arm/Group Description	Patients are randomized 1:1 active/...	Patients are randomized 1:1 active/...
Arm/Group Description	Patients are randomized 1:1 active/placebo. SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.	Patients are randomized 1:1 active/placebo. Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
All-Cause Mortality
	SGX942	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/127 (5.51%)	9/139 (6.47%)
Serious Adverse Events Serious Adverse Events
	SGX942	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	74/127 (58.27%)	64/139 (46.04%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/127 (0.79%)	1/139 (0.72%)
Febrile neutropenia ^† 1	3/127 (2.36%)	2/139 (1.44%)
Cardiac disorders
Acute coronary syndrome ^† 1	0/127 (0.00%)	1/139 (0.72%)
Atrial fibrillation ^† 1	2/127 (1.57%)	0/139 (0.00%)
Cardiac failure ^† 1	0/127 (0.00%)	1/139 (0.72%)
Myocardial infarction ^† 1	0/127 (0.00%)	1/139 (0.72%)
Gastrointestinal disorders
Constipation ^† 1	2/127 (1.57%)	3/139 (2.16%)
Dysphagia ^† 1	5/127 (3.94%)	5/139 (3.60%)
Impaired gastric emptying ^† 1	0/127 (0.00%)	1/139 (0.72%)
Incarcerated inguinal hernia ^† 1	0/127 (0.00%)	1/139 (0.72%)
Large intestine perforation ^† 1	0/127 (0.00%)	1/139 (0.72%)
Nausea ^† 1	3/127 (2.36%)	4/139 (2.88%)
Oral pain ^† 1	0/127 (0.00%)	1/139 (0.72%)
Stomatitis ^† 1	0/127 (0.00%)	2/139 (1.44%)
Upper gastrointestinal haemorrhage ^† 1	1/127 (0.79%)	0/139 (0.00%)
Vomiting ^† 1	4/127 (3.15%)	2/139 (1.44%)
General disorders
Death ^† 1	1/127 (0.79%)	0/139 (0.00%)
Pyrexia ^† 1	5/127 (3.94%)	3/139 (2.16%)
Infections and infestations
Bronchiolitis ^† 1	0/127 (0.00%)	1/139 (0.72%)
Corona virus infection ^† 1	1/127 (0.79%)	0/139 (0.00%)
Device related infection ^† 1	1/127 (0.79%)	0/139 (0.00%)
Gastroenteritis ^† 1	0/127 (0.00%)	1/139 (0.72%)
Lung infection ^† 1	1/127 (0.79%)	1/139 (0.72%)
Neutropenic sepsis ^† 1	2/127 (1.57%)	1/139 (0.72%)
Pneumococcal sepsis ^† 1	1/127 (0.79%)	0/139 (0.00%)
Pneumonia ^† 1	1/127 (0.79%)	2/139 (1.44%)
Sepsis ^† 1	3/127 (2.36%)	1/139 (0.72%)
Septic shock ^† 1	1/127 (0.79%)	0/139 (0.00%)
Urinary tract infection ^† 1	0/127 (0.00%)	1/139 (0.72%)
Injury, poisoning and procedural complications
Radiation oesophagitis ^† 1	0/127 (0.00%)	1/139 (0.72%)
Subdural haematoma ^† 1	1/127 (0.79%)	0/139 (0.00%)
Toxicity to various agents ^† 1	1/127 (0.79%)	1/139 (0.72%)
Wrist fracture ^† 1	0/127 (0.00%)	1/139 (0.72%)
Investigations
Weight decreased ^† 1	0/127 (0.00%)	1/139 (0.72%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/127 (0.79%)	1/139 (0.72%)
Dehydration ^† 1	7/127 (5.51%)	4/139 (2.88%)
Failure to thrive ^† 1	1/127 (0.79%)	1/139 (0.72%)
Hyperglycaemia ^† 1	2/127 (1.57%)	0/139 (0.00%)
Hyperkalaemia ^† 1	0/127 (0.00%)	1/139 (0.72%)
Hyponatraemia ^† 1	1/127 (0.79%)	1/139 (0.72%)
Nervous system disorders
Encephalopathy ^† 1	0/127 (0.00%)	1/139 (0.72%)
Presyncope ^† 1	0/127 (0.00%)	1/139 (0.72%)
Seizure ^† 1	1/127 (0.79%)	0/139 (0.00%)
Syncope ^† 1	2/127 (1.57%)	2/139 (1.44%)
Psychiatric disorders
Alcohol withdrawal syndrome ^† 1	0/127 (0.00%)	1/139 (0.72%)
Renal and urinary disorders
Acute kidney injury ^† 1	12/127 (9.45%)	8/139 (5.76%)
Renal failure ^† 1	0/127 (0.00%)	1/139 (0.72%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/127 (0.79%)	0/139 (0.00%)
Orthopnoea ^† 1	1/127 (0.79%)	0/139 (0.00%)
Pulmonary embolism ^† 1	1/127 (0.79%)	0/139 (0.00%)
Vascular disorders
Embolism ^† 1	4/127 (3.15%)	0/139 (0.00%)
Thrombosis ^† 1	0/127 (0.00%)	1/139 (0.72%)
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SGX942	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	123/127 (96.85%)	135/139 (97.12%)
Blood and lymphatic system disorders
Anaemia ^† 1	20/127 (15.75%)	31/139 (22.30%)
Neutropenia ^† 1	21/127 (16.54%)	16/139 (11.51%)
Ear and labyrinth disorders
Deafness ^† 1	8/127 (6.30%)	7/139 (5.04%)
Hypoacusis ^† 1	7/127 (5.51%)	8/139 (5.76%)
Tinnitus ^† 1	29/127 (22.83%)	37/139 (26.62%)
Gastrointestinal disorders
Constipation ^† 1	71/127 (55.91%)	66/139 (47.48%)
Diarrhoea ^† 1	32/127 (25.20%)	34/139 (24.46%)
Dry mouth ^† 1	61/127 (48.03%)	68/139 (48.92%)
Dyspepsia ^† 1	20/127 (15.75%)	23/139 (16.55%)
Dysphagia ^† 1	55/127 (43.31%)	60/139 (43.17%)
Gastrooesophageal reflux disease ^† 1	8/127 (6.30%)	10/139 (7.19%)
Nausea ^† 1	88/127 (69.29%)	97/139 (69.78%)
Odynophagia ^† 1	17/127 (13.39%)	12/139 (8.63%)
Oesophagitis ^† 1	7/127 (5.51%)	7/139 (5.04%)
Oral pain ^† 1	20/127 (15.75%)	21/139 (15.11%)
Salivary duct inflammation ^† 1	7/127 (5.51%)	4/139 (2.88%)
Stomatitis ^† 1	9/127 (7.09%)	21/139 (15.11%)
Vomiting ^† 1	43/127 (33.86%)	57/139 (41.01%)
General disorders
Asthenia ^† 1	17/127 (13.39%)	11/139 (7.91%)
Chills ^† 1	7/127 (5.51%)	2/139 (1.44%)
Fatigue ^† 1	57/127 (44.88%)	64/139 (46.04%)
Medical device site pain ^† 1	8/127 (6.30%)	6/139 (4.32%)
Pyrexia ^† 1	17/127 (13.39%)	13/139 (9.35%)
Oral candidiasis ^† 1	34/127 (26.77%)	40/139 (28.78%)
Infections and infestations
Candida infection ^† 1	20/127 (15.75%)	20/139 (14.39%)
Injury, poisoning and procedural complications
Radiation skin injury ^† 1	46/127 (36.22%)	55/139 (39.57%)
Investigations
Alanine aminotransferase increased ^† 1	4/127 (3.15%)	9/139 (6.47%)
Blood creatinine increased ^† 1	14/127 (11.02%)	21/139 (15.11%)
Blood urea increased ^† 1	8/127 (6.30%)	4/139 (2.88%)
Lymphocyte count decreased ^† 1	6/127 (4.72%)	9/139 (6.47%)
Neutrophil count decreased ^† 1	12/127 (9.45%)	17/139 (12.23%)
Weight decreased ^† 1	32/127 (25.20%)	34/139 (24.46%)
White blood cell count decreased ^† 1	8/127 (6.30%)	14/139 (10.07%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	38/127 (29.92%)	43/139 (30.94%)
Dehydration ^† 1	26/127 (20.47%)	23/139 (16.55%)
Hyperglycaemia ^† 1	3/127 (2.36%)	7/139 (5.04%)
Hyperkalaemia ^† 1	2/127 (1.57%)	7/139 (5.04%)
Hypokalaemia ^† 1	23/127 (18.11%)	23/139 (16.55%)
Hypomagnesaemia ^† 1	10/127 (7.87%)	17/139 (12.23%)
Hyponatraemia ^† 1	16/127 (12.60%)	11/139 (7.91%)
Musculoskeletal and connective tissue disorders
Neck pain ^† 1	8/127 (6.30%)	5/139 (3.60%)
Nervous system disorders
Dizziness ^† 1	27/127 (21.26%)	17/139 (12.23%)
Dysgeusia ^† 1	58/127 (45.67%)	61/139 (43.88%)
Headache ^† 1	31/127 (24.41%)	23/139 (16.55%)
Somnolence ^† 1	9/127 (7.09%)	8/139 (5.76%)
Psychiatric disorders
Anxiety ^† 1	12/127 (9.45%)	15/139 (10.79%)
Depression ^† 1	4/127 (3.15%)	8/139 (5.76%)
Insomnia ^† 1	14/127 (11.02%)	21/139 (15.11%)
Renal and urinary disorders
Acute kidney injury ^† 1	13/127 (10.24%)	11/139 (7.91%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	15/127 (11.81%)	16/139 (11.51%)
Dysphonia ^† 1	11/127 (8.66%)	12/139 (8.63%)
Dyspnoea ^† 1	5/127 (3.94%)	7/139 (5.04%)
Hiccups ^† 1	18/127 (14.17%)	21/139 (15.11%)
Oropharyngeal pain ^† 1	40/127 (31.50%)	44/139 (31.65%)
Upper-airway cough syndrome ^† 1	7/127 (5.51%)	7/139 (5.04%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	9/127 (7.09%)	11/139 (7.91%)
Erythema ^† 1	8/127 (6.30%)	13/139 (9.35%)
Rash ^† 1	7/127 (5.51%)	5/139 (3.60%)
Skin hyperpigmentation ^† 1	9/127 (7.09%)	5/139 (3.60%)
Vascular disorders
Hypertension ^† 1	4/127 (3.15%)	16/139 (11.51%)
Hypotension ^† 1	10/127 (7.87%)	10/139 (7.19%)
Lymphoedema ^† 1	7/127 (5.51%)	7/139 (5.04%)
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Richard Straube, MD/Chief Medical Officer
Organization:	Soligenix, Inc.
Phone:	609-538-8200
EMail:	rstraube@soligenix.com

Publications:

North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.

Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.

Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.

Layout table for additonal information

Responsible Party:	Soligenix
ClinicalTrials.gov Identifier:	NCT03237325
Other Study ID Numbers:	IDR-OM-02
First Submitted:	July 26, 2017
First Posted:	August 2, 2017
Results First Submitted:	August 3, 2022
Results First Posted:	August 29, 2022
Last Update Posted:	November 8, 2022

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