Summary
EudraCT Number:2021-004979-14
Sponsor's Protocol Code Number:AR-320-003
National Competent Authority:France - ANSM
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2022-04-28
Trial results
A. Protocol Information
A.1Member State ConcernedFrance - ANSM
A.2EudraCT number2021-004979-14
A.3Full title of the trial
A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A study to see if suvratoxumab is safe and works to stop pneumonia developing in people who are on mechanical ventilators who have a bacteria in their lungs, commonly called Staphylococcus, that has not yet caused an infection.
A.3.2Name or abbreviated title of the trial where available
SAATELLITE-2
A.4.1Sponsor's protocol code numberAR-320-003
A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05331885
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 SponsorAridis Pharmaceuticals, Inc.
B.1.3.4CountryUnited States
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 supportAridis Pharmaceuticals, Inc.
B.4.2CountryUnited States
B.4.1Name of organisation providing supportCOMBACTE-NET
B.4.2CountryNetherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationAridis Pharmaceuticals, Inc.
B.5.2Functional name of contact pointClinical Operations
B.5.3 Address:
B.5.3.1Street Address983 University Ave, Building B
B.5.3.2Town/ cityLos Gatos
B.5.3.3Post codeCA 95032-7637
B.5.3.4CountryUnited States
B.5.4Telephone number+1408 385 1742
B.5.5Fax number+1408 960 3822
B.5.6E-mail[email protected]
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.3.2Product code AR-320
D.3.4Pharmaceutical form Solution for infusion
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 INNSUVRATOXUMAB
D.3.9.2Current sponsor codeAR-320
D.3.9.3Other descriptive nameMEDI4893
D.3.9.4EV Substance CodeSUB189814
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
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 Yes
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
Prevention of nosocomial pneumonia
E.1.1.1Medical condition in easily understood language
Prevention of an infection of the lungs that develops within 48 hours or more of hospital admission and which was not developing at the time of admission.
E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10052596
E.1.2Term Nosocomial pneumonia
E.1.2System Organ Class 100000004862
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.
E.2.2Secondary objectives of the trial
1. To evaluate the safety of a single IV dose of suvratoxumab.
2. To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia or death.
3. To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial S. aureus pneumonia.
4. To evaluate the effect of suvratoxumab on reducing the incidence of long-term nosocomial pneumonia caused by S. aureus.
5. To measure the effect of suvratoxumab on the magnitude of healthcare utilization.
6. To evaluate the serum pharmacokinetics (PK) of suvratoxumab.
7. To evaluate the serum Anti-Drug Antibody (ADA) responses to suvratoxumab.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Adult (18 [unless otherwise specified by local Country laws] to 65 years of age) or Adolescent (12 to < 18 years of age [unless otherwise specified by local Country laws]) at the time of screening.
2. Written informed consent and written informed assent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPPA] in the US, EU Data Privacy Directive in the EU) obtained from the subject/legally acceptable representative (LAR) prior to performing any protocol-related procedures, including screening evaluations.
3. Females of childbearing potential (inclusive of adolescents) who are sexually active with a non-sterilized male partner must have evidence of not being pregnant upon enrolment and have a negative pregnancy test prior to administration of investigational product.
- Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral oophorectomy, or complete hysterectomy), premenarchal or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
4. Tracheal or bronchial sample positive by polymerase chain reaction (PCR) for S. aureus within 36 hours prior to randomization. Note: the 36-hour window will be determined by the time of sample collection.
5. Currently intubated and on mechanical ventilation in the ICU.
6. Expected to remain intubated and mechanically ventilated for ≥ 3 days based on investigator estimate.
7. No diagnosis of new-onset pneumonia within 72 hours prior to randomization (subjects with evidence of resolved pneumonia will be eligible).
E.4Principal exclusion criteria
1. The study subject is moribund or unlikely to survive for a week post randomization despite delivery of adequate antibiotics and supportive care, based on clinical judgement by the PI.
2. Acute confirmed or suspected active S. aureus disease at study enrolment and investigational product dosing (colonization is acceptable as per inclusion criterion #4).
3. Active pulmonary disease that would impair the ability to diagnose pneumonia, such as active tuberculosis or fungal disease, obstructing lung cancer, large empyema, cystic fibrosis, or acute respiratory distress syndrome with lung "white out".
4. Receipt of anti- S. aureus systemic antibiotics for > 48 hours within 72 hours prior to randomization that are considered active against the S. aureus strain with which the subject is colonized, or anticipated ongoing receipt of anti- S. aureus systemic antibiotics.
5. APACHE-II score ≥ 25 (if Glasgow Coma Scale [GCS] score is > 5) or ≥ 30 (if GCS score is ≤ 5), or SOFA score ≥ 9 at time of randomization.
- Note: Vasopressors only used to improve cerebral perfusion pressure (e.g., subarachnoid hemorrhage) will not be entered in the calculation of the cardiovascular component of the SOFA score.
6. Receipt of any investigational drug therapy within 30 days prior to randomization.
7. Previous receipt of a mAb within 60 days prior to randomization.
8. Subjects with a CD4 count of < 200 due to advanced human immunodeficiency virus (HIV) infection. Subjects with a history of HIV infection who have been on highly active antiretroviral therapy and asymptomatic from HIV infection for at least 6 months may be enrolled.
9. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
10. Not able to complete long-term follow-up for at least 90 days post dose based on investigator judgment.
11. Pregnant female or nursing mother.
E.5 End points
E.5.1Primary end point(s)
Incidence of nosocomial all-cause pneumonia through 30 days post dose.
E.5.1.1Timepoint(s) of evaluation of this end point
Any time through 30 days post dose.
E.5.2Secondary end point(s)
1. TEAEs and clinical laboratory assessments through 30 days post dose, and TESAEs and TEAEs of special interest (TEAESI) through 90 days, and for a subset of subjects through 180 days post dose.
2. Incidence of nosocomial all-cause pneumonia or death through 30 days post dose.
3. Incidence of nosocomial S. aureus pneumonia through 30 days post dose.
4. Incidence of nosocomial pneumonia caused by S. aureus through 90 days post dose.
5. Magnitude of healthcare utilization (e.g., duration of mechanical ventilation, duration of ICU stay, duration of hospital stay, number of and days of systemic antibiotic use) through 90 days post dose in all subjects and in a subset of subjects through 180 days post dose.
6. Suvratoxumab serum concentration and PK parameters through 30 days post dose, and in a subset of subjects through 90 days post dose.
7. Suvratoxumab ADA response in serum through 30 days post dose, and in a subset of subjects through 90 days post dose.
E.5.2.1Timepoint(s) of evaluation of this end point
1. Any time through 30 days post dose; any time through 90 days post dose; in a subset of subjects any time through 180 days post dose.
2. Any time through 30 days post dose.
3. Any time through 30 days post dose.
4. Any time through 90 days post dose.
5. Any time through 90 days post dose; in a subset of subjects any time through 180 days post dose.
6. Any time through 30 days post dose; in a subset of subjects any time through 90 days post dose.
7. Any time through 30 days post dose; in a subset of subjects any time through 90 days post dose.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
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 concerned16
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA65
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
Belgium
France
Greece
Israel
Netherlands
Portugal
Spain
Switzerland
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
The end of the trial is defined as the date of the last protocol - specified visit/ assessment (including telephone contact) for the last subject in the study.
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 months6
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 months6
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 14
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) Yes
F.1.1.6.1Number of subjects for this age range: 14
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 550
F.1.3Elderly (>=65 years) No
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 Yes
F.3.3.2Women of child-bearing potential using contraception No
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 Yes
F.3.3.6.1Details of subjects incapable of giving consent
Intubated and on mechanical ventilation in the Intensive Care Unit (ICU).
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state54
F.4.2 For a multinational trial
F.4.2.1In the EEA 105
F.4.2.2In the whole clinical trial 564
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
G.4 Investigator Network to be involved in the Trial: 1
G.4.1Name of Organisation COMBACTE-NET
G.4.3.4Network Country Netherlands
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-08-18
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status