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    The EU Clinical Trials Register currently displays   41467   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2017-003702-41
    Sponsor's Protocol Code Number:IDR-OM-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-12-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-003702-41
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
    A.3.2Name or abbreviated title of the trial where available
    IDR-OM-02
    A.4.1Sponsor's protocol code numberIDR-OM-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03237325
    A.5.4Other Identifiers
    Name:US IND NumberNumber:117,853
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSoligenix UK Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSoligenix, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNational Institutes of Health
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSoligenix, Inc.
    B.5.2Functional name of contact pointRichard Straube, MD
    B.5.3 Address:
    B.5.3.1Street Address29 Emmons Drive; Suite C-10
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908235-1146
    B.5.6E-mailRStraube@Soligenix.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDusquetide
    D.3.2Product code SGX942
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDusquetide
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeSGX942
    D.3.9.3Other descriptive nameSGX94, IMX-001, IMX-942
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
    E.1.1.1Medical condition in easily understood language
    Ulcer formation in the mouth
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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 lesion ≥3) in patients receiving fractionated radiation treatments and concomitant cisplatin chemotherapy, given as 80-100 mg/m2 every third week, for the treatment of squamous cell carcinoma of the oral cavity or oropharynx.
    E.2.2Secondary objectives of the trial
    To assess the impact of SGX942 compared to placebo on the following clinically important secondary objectives:
    1. To assess the impact that SGX942 has on the Area-Under-the-Curve (AUC) for SOM (WHO Grade ≥3) by time plot (severity-weighted duration)
    2. To assess the impact that SGX942 has on the Area-Under-the-Curve (AUC) for ulcerative oral mucositis (UOM; defined as WHO Grade ≥2) by time plot (severity-weighted duration)
    3. To assess the impact that SGX942 has on the incidence of SOM
    4. To assess the impact that SGX942 has on the quality of life assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Question for Head and Neck Cancer 43 question (QLQH& N43) instrument
    5. To assess the impact that SGX942 has on the amount of opioids used
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria in order to be eligible for enrollment:
    1. Willing and able to understand and sign an informed consent
    2. Males or females age greater than or equal to 18 years
    3. Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases that has been evaluated for human papillomavirus (HPV)
    4. Scheduled to receive cisplatin chemotherapy of 80-100 mg/m² given every third week
    5. Scheduled to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy at each site
    6. Planned radiation treatment fields must include at least 2 oral sites (retromolar trigone, buccal mucosa, floor of mouth, tongue, or soft palate), with each site receiving ≥55 Gy
    7. Female subjects of childbearing potential who are less than 2 years postmenopausal must agree to and comply with using birth control while participating in this study
    E.4Principal exclusion criteria
    Patients with any of the following criteria are NOT eligible for enrollment:
    1. Current mucositis
    2. Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
    3. Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
    4. Current use of prohibited therapies listed in Section 8.2
    5. Prior radiation to the head and neck
    6. Chemotherapy treatment within the previous 12 months
    7. Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
    8. Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following (the below are examples of evidence of significant disease, not required tests):
    A. Estimated creatinine clearance <30 mL/min
    B. ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal
    C. Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
    D. Thrombocytopenia (less than 60,000 cells/mm3)
    E. CD4+ T cell count below 200 cells per μL (verification only required if there is a clinical diagnosis of HIV infection)
    9. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
    10. Women who are pregnant or breast-feeding
    11. Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
    12. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or quality of the data
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome for this study is the duration of SOM, defined as the number of days from the first oral examination with a WHO Grade assessment of ≥3 until the first time the patient has a WHO Grade of <3 with no subsequent readings ≥3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical evaluation of mucositis will be performed and graded by trained study evaluators in accordance with WHO Oral Mucositis Grading system at each study drug administration visit, which is twice a week to a maximum of 9 weeks, and thereafter once a week through 6 weeks post-RT (see Table 7 of Protocol)
    E.5.2Secondary end point(s)
    Secondary endpoints will be analyzed in hierarchical order:
    1. The Area-Under-the-Curve (AUC) for SOM (WHO Grade ≥3) by time plot (severity-weighted duration)
    2. The Area-Under-the-Curve (AUC) for ulcerative oral mucositis (UOM; defined as WHO Grade ≥2) by time plot (severity-weighted duration)
    3. The incidence of SOM
    4. The quality of life assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Question for Head and Neck Cancer 43 question (QLQH& N43) instrument
    5. The amount of opioids used

    The following secondary endpoints will also be examined:
    • The cumulative number of days of radiation treatment breaks
    • The duration of SOM in patients receiving a cumulative minimum of 55 Gy of fractionated RT and concomitant cisplatin chemotherapy, given as 80-100 mg/m2 every third week (mITT population)
    • The duration of UOM
    • The cumulative amount of pain reported by patients
    • The duration of SOM using an alternative definition calculated as the number of days from the first oral examination with WHO grade ≥3 through the last assessment with a WHO score ≥3 (and not to the first assessment with a WHO grade <3) with no further reports of a WHO grade ≥3.
    • The duration of SOM in the Per-Protocol Population defined as patients receiving a cumulative radiation dose of at least 55 Gy and all scheduled study drug.

    Safety:
    • The incidence, type, and body system categorization of AEs
    • The incidence, type, and body system categorization of SAEs
    • The changes from Baseline for hematology parameters, clinical chemistry parameters, and vital signs
    • Tumor status at 12 weeks and 12 months following completion of RT categorized using the RECIST criteria
    • The incidence and severity of reported infections assessed by CTCAE grading
    • The 12 month post-RT survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to Table 7 of the protocol and section 10.2. Secondary Efficacy Endpoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 201
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 260
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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