NCT03237325

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

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Soligenix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

Conditions

• Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
• Oral Mucositis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2017-12-04
• Primary completion: 2020-06-24
• Completion: 2021-06-24
• First posted: 2017-08-02
• Last updated: 2022-11-08
• Results posted: 2022-08-29

Locations

53 sites across 5 countries: United States, Belgium, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study