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    Summary
    EudraCT Number:2021-002395-39
    Sponsor's Protocol Code Number:WN43174
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-01
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-002395-39
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI-N-METHYL-D-ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI-LEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with NMDAR or LGI1 mediated autoimmune Encephalitis
    A.4.1Sponsor's protocol code numberWN43174
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name Enspryng
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSatralizumab
    D.3.2Product code Ro 533-3787/F01- 04
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSatralizumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.4EV Substance CodeSUB195082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.IMP: 2
    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 nameSatralizumab
    D.3.2Product code Ro 533-3787/F01- 06
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSatralizumab
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.4EV Substance CodeSUB195082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NMDAR or LGI1 mediated autoimmune Encephalitis
    E.1.1.1Medical condition in easily understood language
    Autoimmune encephalitis is inflammation of the brain caused by autoimmune Response
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072378
    E.1.2Term Encephalitis autoimmune
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Part 1: To evaluate the efficacy of satralizumab compared with placebo on degree of disability and clinical severity, as measured by a 1 point improvement in the Modified Rankin Scale (mRS)
    • Part 2: To evaluate the long-term safety and tolerability of satralizumab
    E.2.2Secondary objectives of the trial
    • Part 1: To evaluate the efficacy of satralizumab compared with placebo
    based on time to Modified Rankin Scale (mRS score), time to rescue
    therapy, proportion of participants with sustained seizure cessation,
    change in Clinical Assessment Scale in Autoimmune Encephalitis (CASE)
    score, Montreal Overall Cognitive Assessment (MOCA) total score, Rey
    Auditory Verbal Learning Test (RAVLT) score, and mRS score
    • Part 1: To evaluate the safety of satralizumab compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
    • Onset of autoimmune encephalitis (AIE) symptoms <=9 months before randomization
    • Meet the definition of "New Onset" or "Incomplete Responder" AIE
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo
    • For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
    N-methyl-D-aspartic acid receptor (NMDAR) AIE Cohort
    • Age >=12 years
    • Diagnosis of probable or definite NMDAR encephalitis
    Leucine-rich glioma-inactivated 1 (LGI1) AIE Cohort
    • Age >=18 years
    • Diagnosis of LGI1 encephalitis
    E.4Principal exclusion criteria
    • Any untreated teratoma or thymoma at baseline visit (randomization)
    • History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
    • For patients with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
    • Historically known positivity to an intracellular antigen with high cancer association or GAD-65
    • • Historically known positivity to any cell surface neuronal antibodies
    other than NMDAR and LGI1, in the absence of NMDAR and LGI1
    antibody positivity
    • Confirmed paraneoplastic encephalitis
    • Confirmed central or peripheral nervous system demyelinating disease
    • Alternative causes of associated symptoms
    • History of herpes simplex virus encephalitis in the previous 24 weeks
    • Any previous/concurrent treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation
    • Any previous treatment with anti-CD19 antibody, complement inhibitors, neonatal Fc receptor antagonists, anti−B-lymphocyte stimulator monoclonal antibody
    • Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
    • Treatment with oral cyclophosphamide within 1 year prior to baseline Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening
    • Concurrent use of more than one IST as background therapy
    • Contraindication to all of the following rescue treatments: rituximab, IVIG, highdose corticosteroids, or intravenous (IV) cyclophosphamide
    • Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal
    • Planned surgical procedure during the study
    • Evidence of progressive multifocal leukoencephalopathy
    • Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
    • Congenital or acquired immunodeficiency, including HIV infection
    • Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection
    • Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit
    • Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening
    • Evidence of latent or active tuberculosis (TB)
    • History of drug or alcohol abuse within 1 year prior to baseline
    • History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator’s opinion, may lead to increased risk of complications such as GI perforation
    • Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit
    • History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening
    • History of severe allergic reaction to a biologic agent
    • A history of suicide attempt within 3 years prior to screening except if
    this is clearly associated with and occurs during the acute phase of LGI-1
    or NMDAR encephalitis
    • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug
    • Laboratory abnormalities at Screening
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of participants with mRS score improvement >=1 from baseline and no use of rescue therapy at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 24
    E.5.2Secondary end point(s)
    1. Time to mRS score improvement >=1 from baseline without use of
    rescue therapy
    2. Time to rescue therapy
    3. Proportion of participants with sustained seizure cessation at Week
    24, as defined by 4 consecutive weeks of no seizures maintained until
    Week 24, and no use of rescue therapy
    4. Change in CASE score from baseline at Week 24
    5. MOCA total score at Week 24
    6. RAVLT score at Week 24 (LGI1 AIE cohort)
    7. mRS score at Week 24 (as measured on a 7-point scale; NMDAR AIE
    cohort)
    8. Incidence, seriousness, and severity of adverse events, with severity
    determined according to National Cancer Institute Common Terminology
    Criteria for Adverse Events, Version 5.0
    9. Change from baseline in targeted vital signs, clinical laboratory test
    results, electrocardiogram (ECG) results, weight, height (<18 years
    only), and Columbia-Suicide Severity Rating Scale (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Up to approximately 5 years
    4. Baseline (Day -28 to Day 1) to Week 24
    5-7. At Week 24
    8. Up to approximately 5 years
    9. Baseline (Day -28 to Day 1) to approximately 5 years
    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 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 Yes
    E.8.1.7.1Other trial design description
    Basket Study
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Argentina
    Ghana
    Brazil
    China
    Japan
    Korea, Republic of
    Russian Federation
    United States
    Denmark
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 16
    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) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-06-01. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For participants unable to give consent due to the severity of their disease, the ICF may be signed by a legally authorized representative and participant assent obtained, as per local requirements.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 152
    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)
    Participants can continue to receive treatment with study drug until the availability of satralizumab as post-trial access in accordance with local regulation, or until the Sponsor decides to discontinue the development program.
    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 Decision2022-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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