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    Summary
    EudraCT Number:2021-002609-93
    Sponsor's Protocol Code Number:DRI17224
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002609-93
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment, and who are naïve to omalizumab
    Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, multicéntrico y de determinación del rango de dosis de rilzabrutinib seguido de una fase de extensión abierta en pacientes con urticaria crónica espontánea (UCE) de moderada a grave que siguen sintomáticos a pesar del uso de tratamiento antihistamínico H1 y sin tratamiento previo con omalizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rilzabrutinib for the treatment of chronic spontaneous urticaria in patients who remain symptomatic despite the use of H1 antihistamine and who are naïve to omalizumab
    Rilzabrutinib para el tratamiento de la urticaria crónica espontánea en pacientes que siguen sintomáticos a pesar del uso de antihistamínicos H1 y sin tratamiento previo con omalizumab
    A.4.1Sponsor's protocol code numberDRI17224
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1263-4226
    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 SponsorSanofi aventis recherche et developpement
    B.1.3.4CountryFrance
    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 supportSanofi Aventis Recherche et Developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 nameRilzabrutinib
    D.3.2Product code SAR444671
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRilzabrutinib
    D.3.9.2Current sponsor codeSAR444671
    D.3.9.3Other descriptive namePRN1008
    D.3.9.4EV Substance CodeSUB192772
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic spontaneous urticaria
    Urticaria crónica espontánea
    E.1.1.1Medical condition in easily understood language
    Chronic spontaneous urticaria
    Urticaria crónica espontánea
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of rilzabrutinib in study participants with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamines (H1-AH)
    Demostrar la eficacia de rilzabrutinib en los participantes del estudio con urticaria crónica espontánea (UCE) que siguen sintomáticos a pesar del uso de antihistamínicos H1 (AH-H1).
    E.2.2Secondary objectives of the trial
    • To demonstrate the efficacy of rilzabrutinib on urticaria activity composite endpoint and itch or hives, separately, at various time points
    • To evaluate safety outcome measures
    • To assess the plasma PK of rilzabrutinib in participants with CSU
    • Demostrar la eficacia de rilzabrutinib con respecto al criterio de valoración compuesto de la actividad de la urticaria y el picor o las ronchas, por separado, en diversos momentos.
    • Evaluar las medidas de los resultados de seguridad.
    • Evaluar la FC en plasma de rilzabrutinib en participantes con UCE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants who have a diagnosis of CSU refractory to H1-AH at the time of randomization
    - Diagnosis of CSU ≥3 months prior to screening visit (Visit 1).
    - The presence of itch and hives for ≥6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period.
    - Participants using a study defined H1-AH for CSU treatment. For participants on stable doses of non-study-approved H1-AH, investigators may switch participants to an equivalent dose of a study-approved H1-AH maintenance medication.
    - Participants who are omalizumab naïve.
    - Participants must be willing and able to complete a daily symptom e-diary for the duration of the study.
    - During the 7 days before randomization: UAS7 ≥16 and ISS7 ≥8
    - Body mass index (BMI) >17.5 and <40 kg/m2.
    - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    - Participantes que tienen un diagnóstico de UCE refractario a AH-H1 en el momento de la aleatorización.
    - Diagnóstico de UCE ≥3 meses antes de la visita de selección (visita 1).
    - Participantes que utilizan un AH-H1 definido en el estudio para el tratamiento de la UCE. En el caso de los participantes que estén recibiendo dosis estables de un AHH1 no aprobado para el estudio, los investigadores podrán cambiar la dosis de los participantes a una dosis equivalente a la de un medicamento AH-H1 de mantenimiento aprobado para el estudio.
    - Participantes sin tratamiento previo con omalizumab.
    - Los participantes deben estar dispuestos y ser capaces de rellenar un diario electrónico de síntomas diariamente durante todo el estudio.
    - Durante los 7 días previos a la aleatorización: UAS7 ≥16 y ISS7 ≥8.
    - Índice de masa corporal (IMC) >17,5 y <40 kg/m2
    - Todo uso de anticonceptivos por parte de varones y mujeres debe estar en consonancia con la regulación local relativa a los métodos anticonceptivos para los participantes en estudios clínicos.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Clearly defined underlying etiology for CUs other than CSU (main manifestation being physical urticaria)
    - Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
    - Participants with active atopic dermatitis (AD).
    - Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study.
    - Known or suspected immunodeficiency, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
    - History of serious infections requiring intravenous (IV) therapy with the potential for recurrence or currently active moderate to severe infection at Screening, including active coronavirus disease 2019 (COVID-19).
    - Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening.
    - Active malignancy or history of malignancy within 5 years
    - Conditions that may predispose the participant to excessive bleeding
    - Any participant with an uncontrolled disease state as judged by the Investigator, such as asthma, psoriasis, or inflammatory bowel disease, etc. that are typically treated with oral or parenteral corticosteroids
    - Previous use of a BTK inhibitor.
    - Has received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at least 5 times the respective elimination half-life time (whichever is longer).
    - Previous exposure to another investigative antibody for CSU
    - Positive for human immunodeficiency virus (HIV) antibody test.
    - Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with positive DNA test result at screening or within 3 months prior to the screening visit.
    - Positive hepatitis C antibody test result at screening or within 3 months prior to the screening visit.
    - Tuberculosis infection
    - Any of significant laboratory abnormalities and ECG findings at the screening visit
    Se excluirá del estudio a los participantes que cumplan cualquiera de los siguientes criterios:
    - Etiología subyacente claramente definida para UC distinta a la UCE (donde la manifestación principal es la urticaria física).
    - Presencia de morbilidades cutáneas distintas de la UCE que puedan interferir en la evaluación de los resultados del estudio.
    - Participantes con dermatitis atópica (DA) activa.
    - Enfermedad(es) concomitante(s) grave(s) que, a criterio del investigador, pudiera(n) afectar negativamente la participación del paciente en el estudio.
    - Inmunodeficiencia conocida o sospechada, incluidos los antecedentes de infecciones oportunistas invasivas (p. ej., histoplasmosis, listeriosis, coccidioidomicosis, neumocistosis y aspergilosis), a pesar de la resolución de la infección, o infecciones recurrentes de frecuencia anormal o de duración prolongada que sugieran un estado inmunocomprometido, a juicio del investigador.
    - Antecedentes de infecciones graves recurrentes que requieran tratamiento intravenoso, o infección activa de moderada a grave en curso en la visita de selección (grado 2 o superior), incluida la enfermedad por coronavirus 2019 (COVID-19) activa.
    - Vacuna de virus vivos atenuados, excepto la vacuna del bacilo de Calmette-Guérin, en los 28 días anteriores al día 1 o tenga programado recibir una durante el ensayo; vacunación con bacilo de Calmette-Guérin en los 12 meses anteriores a la visita de selección.
    - Neoplasia maligna activa o antecedentes de neoplasia maligna en los 5 años previos.
    - Condiciones que pueden predisponer a la participante a un sangrado excesivo.
    - Cualquier participante con un estado de enfermedad incontrolado según juicio del investigador, como asma, psoriasis o enfermedad intestinal inflamatoria, etc. que normalmente se tratan con corticoesteroides orales o parenterales.
    - Uso previo de un inhibidor de la BTK.
    - Haber recibido cualquier medicamento en investigación (o estar usando actualmente un dispositivo en investigación) en los 30 días anteriores al día 1 o, al menos, 5 veces el tiempo de semivida de eliminación respectivo (lo que suponga más tiempo).
    - Exposición previa a otro anticuerpo en investigación para la UCE.
    - Resultado positivo para la prueba de anticuerpos contra el virus de la inmunodeficiencia humana (VIH).
    - Presencia de antígeno de superficie del virus de la hepatitis B (AgsHB) o anticuerpo contra el antígeno central del virus de la hepatitis B (HBcAb) con resultado positivo en la prueba de ADN en la selección o en los 3 meses anteriores a la visita de selección.
    - Resultado positivo para la prueba de anticuerpos contra el virus de la hepatitis C (VHC) en la selección o en los 3 meses anteriores a la visita de selección.
    - Infección por tuberculosis.
    - Cualquier anomalía de laboratorio significativa y/o hallazgos del ECG en la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Change from baseline in weekly urticaria activity score (UAS7) at Week 12 (except US and US reference countries)
    2 - For US and US reference countries only: change from baseline in weekly itch severity score (ISS7) at Week 12
    1- Cambio con respecto al momento inicial en la puntuación semanal de la actividad de la urticaria (UAS7) en la semana 12 (excepto en EE. UU. y los países de referencia de EE. UU.).
    2- Solo para EE. UU. y los países de referencia de EE. UU.: cambio con respecto al momento inicial en la puntuación semanal de la severidad del picor (ISS7) en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2 - From baseline to Week 12
    1,2 - Desde el momento inicial hasta la semana 12.
    E.5.2Secondary end point(s)
    1 - Change from baseline in UAS7 at Week 4
    2 - Change from baseline in ISS7 at Week 12 (except US and US reference countries)
    3 - For US and US reference countries only: change from baseline in UAS7 at Week 12
    4 - Change from baseline in weekly hives severity score (HSS7) at Week 12
    5 - Proportion of participants with UAS7 ≤6 at Week 12
    6 - Proportion of participants with UAS7 = 0 at Week 12
    7 - Percentages of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the double blind phase
    8 - Percentages of participants experiencing TEAEs or SAEs during the open lable extension (OLE) phase
    9 - Plasma PK concentrations of rilzabrutinib in participants with CSU
    1- Cambio con respecto al momento inicial en la UAS7 en la semana 4.
    2- Cambio con respecto al momento inicial en la ISS7 en la semana 12 (excepto en EE. UU. y los países de referencia de EE. UU.).
    3- Solo para EE. UU. y los países de referencia de EE. UU.: cambio con respecto al momento inicial en la UAS7 en la semana 12.
    4- Cambio con respecto al momento inicial en la puntuación semanal de la severidad de las ronchas (HSS7) en la semana 12.
    5- Proporción de participantes con UAS7 ≤6 en la semana 12.
    6- Proporción de participantes con UAS7 = 0 en la semana 12.
    7- Porcentaje de los participantes que experimentan acontecimientos adversos derivados del tratamiento (AADT) o acontecimientos adversos graves (AAG) durante la fase de doble ciego.
    8- Porcentaje de los participantes que experimentan AADT o AAG durante la fase de extensión abierta (OLE).
    9- Concentraciones plasmáticas de FC de rilzabrutinib en participantes con UCE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - From baseline to Week 4
    2, 3, 4 - From baseline to Week 12
    5, 6 - At Week 12
    7 - Until Week 12
    8, 9 - Until Week 52
    1 - Desde el momento inicial hasta la semana 4.
    2,3,4 - Desde el momento inicial hasta la semana 12.
    5,6 - En la semana 12.
    7 - Hasta la semana 12.
    8,9 - Hasta la semana 52.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    Germany
    Italy
    Poland
    Spain
    Argentina
    E.8.7Trial has a data monitoring committee No
    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
    La última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 213
    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 Decision2021-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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