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    Summary
    EudraCT Number:2021-002669-16
    Sponsor's Protocol Code Number:GA43512
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-12-28
    Trial results View 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 number2021-002669-16
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT AND DOSE-RANGING STUDY OF MTPS9579A IN PARTICIPANTS WITH REFRACTORY CHRONIC SPONTANEOUS URTICARIA
    ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, CON ENMASCARAMIENTO DOBLE, COMPARATIVO CON PLACEBO Y DE BÚSQUEDA DE DOSIS DE MTPS9579A EN PARTICIPANTES CON URTICARIA CRÓNICA ESPONTÁNEA RESISTENTE AL TRATAMIENTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MTPS9579A in Participants with Refractory Chronic Spontaneous Urticaria
    estudio de MTPS9579A en participantes con urticaria crónica espontánea refractaria
    A.4.1Sponsor's protocol code numberGA43512
    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 SponsorGenentech 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    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.5.4Telephone number+349132557300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@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 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 nameMTPS9579A
    D.3.2Product code RO7198434
    D.3.4Pharmaceutical form Solution for injection/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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeRO7198434
    D.3.9.3Other descriptive nameRO7198434 (MTPS9579A)
    D.3.9.4EV Substance CodeSUB195292
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 injection/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
    Refractory Chronic Spontaneous Urticaria
    Urticaria crónica espontánea refractaria
    E.1.1.1Medical condition in easily understood language
    Urticaria (hives) are red, itchy welts that result from a skin reaction. Chronic spontaneous urticaria is defined as persistent symptoms of urticaria with no specific trigger for 6 weeks or more.
    La urticaria son ronchas rojas que pican de una reacción de la piel.La urticaria crónica espontánea son síntomas persistentes de urticaria sin un desencadenante específico durante 6 semanas o más.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 evaluate the efficacy of MTPS9579A compared with placebo based on change from baseline in the Urticaria Activity Score summed over 7 days (UAS7)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of MTPS9579A compared with placebo based on proportion of patients with well-controlled urticaria (UAS7<=6) and patients who achieve complete response (UAS7=0)
    • To evaluate the safety of MTPS9579A compared with placebo
    • To characterize the pharmacokinetic (PK) profile of MTPS9579A
    • To evaluate the immune response to MTPS9579A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-75 years
    • Body mass index (BMI) of 18-38 kg/m^2 and weight >=40 kg at screening
    • Diagnosis of CSU refractory to second-generation H1 antihistamine (sgH1-AHs) at the time of randomization
    • Demonstrated compliance with required use of the Urticaria eDiary
    • For patients on H2 antihistamines or leukotriene receptor antagonists (LTRAs) for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
    • Use of contraceptive measures
    -18 y 75 años

    -índice de masa corporal (IMC) de 18−38 kg/m2 y pesar ≥ 40 kg en el momento de la selección.
    -Diagnóstico de UCE resistente a AH-H1sg en el momento de la aleatorización
    - Cumplimiento demostrado con el uso requerido de Urticaria eDiary
    - Para los pacientes que tomen antihistamínicos H2 o antagonistas del receptor de leucotrienos (ARLT) indicados en afecciones distintas a la UCE (como para la ERGE o el asma): tratamiento a una dosis estable durante ≥ 2 semanas anteriores a la selección, sin cambios previstos a lo largo del estudio, incluido el periodo de selección
    - Uso de medidas anticonceptivas.
    E.4Principal exclusion criteria
    • Previous participation in a clinical trial of MTPS9579A
    • Chronic urticaria with known cause or other diseases with symptoms of urticaria or angioedema
    • Skin disease associated with chronic itching
    • Uncontrolled disease where flares are commonly treated with systemic corticosteroids
    • History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study
    -Participación previa en un ensayo clínico con MTPS9579A.

    -Urticaria crónica con causa conocida u otras enfermedades con síntomas de urticaria o angioedema
    -Dermatosis asociada a prurito crónico
    -Enfermedad no controlada en la que las reagudizaciones se tratan con frecuencia con corticoesteroides sistémicos
    -Antecedentes o evidencia de cualquier condición / enfermedad médica clínicamente significativa o anomalías en las pruebas de laboratorio que, a juicio del investigador, impidan la participación segura del paciente y la finalización del estudio, o interfieran con la realización e interpretación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in the UAS7 at Week 12
    1. Cambio con respecto al valor inicial en el UAS7 en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Week 0) and Week 12
    1. Visita basal (semana 0) y semana 12
    E.5.2Secondary end point(s)
    1. Proportion of patients with well-controlled urticaria (UAS7 <=6) at Week 12
    2. Proportion of patients who achieve complete response (UAS7 =0) at Week 12
    3. Incidence and severity of adverse events, with severity determined according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS toxicity grading scale), with slight modifications for clarity and for alignment with internal practices
    4. Change from baseline in targeted vital signs, physical examination findings, clinical laboratory test results, and ECG parameters
    5. Serum concentration of MTPS9579A at specified timepoints
    6. Prevalence and incidence of anti-drug antibodies (ADAs) to MTPS9579A during the study
    1. Proporción de pacientes con urticaria bien compensada (UAS7<= 6) en la semana 12.
    2. Proporción de pacientes que logran una respuesta completa (UAS7 =0) en la semana 12.
    3. Incidencia e intensidad de acontecimientos adversos, evaluada esta última según la tabla de la División de sida (DAIDS) para la clasificación de la gravedad de los acontecimientos adversos en adultos y niños (HHS, 2017) (en lo sucesivo, denominada la escala de grados de toxicidad de la DAIDS), con pequeñas modificaciones para mayor claridad y para adaptarla a las prácticas internas.
    4. Cambios con respecto al inicio en los parámetros vitales pertinentes, los hallazgos de la exploración física, los resultados de las pruebas analíticas y los parámetros del ECG.
    5. Concentraciones séricas de MTPS9579A en momentos especificados
    6. Prevalencia de anticuerpos antifármaco (AAF) en el momento inicial e incidencia de AAF durante el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. At Week 12
    3. Up to Week 25
    4. Baseline (Week 0) to Week 20
    5. At Weeks 0, 1, 4, 8, 12 and 20
    6. At Weeks 0, 4, 12 and 20
    1-2. En la semana 12
    3. Hasta la semana 25
    4.Visita basal (semana 0) a semana 20
    5. En las semanas 0, 1, 4, 8, 12 y 20
    6. En las semanas 0, 4, 12 y 20
    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 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Poland
    Spain
    United States
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV), occurs or safety follow-up is received from the last patient, whichever occurs later. The end of the study is expected to occur 20 weeks after the last patient is enrolled.
    In addition, the Sponsor may decide to terminate the study at any time.
    El final de este estudio se define como la fecha en que se produce el último paciente, la última visita (LPLV) o se recibe el seguimiento de seguridad del último paciente, lo que ocurra más tarde. Se espera que el final del estudio ocurra 20 semanas después de que se inscriba al último paciente.
    Además, el Patrocinador puede decidir finalizar el estudio en cualquier momento.
    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 months1
    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 months1
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 30
    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)
    Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide the Genentech IMP (MTPS9579A) or any other study treatments to patients who have completed the study.
    The Sponsor may evaluate whether to continue providing MTPS9579A in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Actualmente, el Promotor (Genentech, miembro del Grupo Roche) no tiene planes de proporcionar Genentech IMP (MTPS9579A) ni ningún otro tratamiento del estudio a los pacientes que hayan completado el estudio.
    El Promotor puede evaluar si continúa proporcionando MTPS9579A de acuerdo con la Política global de Roche sobre acceso continuo a medicamentos en investigación, disponible en el siguiente sitio web: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2022-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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