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    Summary
    EudraCT Number:2021-006447-95
    Sponsor's Protocol Code Number:CDX0159-07
    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:2022-06-17
    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 number2021-006447-95
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Inducible Urticaria
    Estudio de fase II de búsqueda de dosis, aleatorizado, doble ciego y controlado con un
    placebo, para evaluar la eficacia y la seguridad del CDX-0159 en pacientes con urticaria
    crónica inducible
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    No aplica.
    A.4.1Sponsor's protocol code numberCDX0159-07
    A.5.4Other Identifiers
    Name:INDNumber:140159
    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 SponsorCelldex Therapeutics
    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 supportCelldex Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelldex Therapeutics, Inc.
    B.5.2Functional name of contact pointPhilip Golden
    B.5.3 Address:
    B.5.3.1Street Address160 Gould Street, Suite 202
    B.5.3.2Town/ cityNeedham
    B.5.3.3Post codeMA 02494
    B.5.3.4CountryUnited States
    B.5.4Telephone number17812348713
    B.5.6E-mailpgolden@celldex.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 nameCDX-0159
    D.3.2Product code CDX-0159
    D.3.4Pharmaceutical form Suspension for injection
    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 INNCDX-0159
    D.3.9.1CAS number 2438203-51-9
    D.3.9.2Current sponsor codeCDX-0159
    D.3.9.3Other descriptive nameHumanised IgG1k monoclonal antibody against KIT
    D.3.9.4EV Substance CodeSUB219179
    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
    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
    Chronic Inducible Urticaria
    Urticaria Inducible Crónica (CIndU)
    E.1.1.1Medical condition in easily understood language
    Long-lasting hives with an unknown cause
    Habones de larga duración de origen desconocido
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10012499
    E.1.2Term Dermatographic urticaria
    E.1.2System Organ Class 100000004858
    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 different dose regimens of CDX-0159 compared to placebo, in achieving a negative provocation test in patients with H1AH refractory CIndU in each subtype (ColdU and SD).
    Evaluar la eficacia de diferentes regímenes de dosis de CDX-0159 en comparación con el placebo, para lograr una prueba de provocación negativa en pacientes con UICd refractaria a H1AH en cada subtipo: Urticaria por Frío (ColdU) y Dermografismo sintomático(SD).
    E.2.2Secondary objectives of the trial
    •To evaluate efficacy of different dose regimens of CDX-0159 compared to placebo, in improving provocation thresholds and itch triggered by provocation
    test in each CIndU subtype.
    •To evaluate efficacy of different dose regimens of CDX-0159 compared to placebo, in achieving a negative provocation test and improving itch triggered
    by provocation test in combined CIndU patients.
    •To evaluate the safety profile of different dose regimens of CDX-0159 compared to placebo, in each CIndU subtype, and combined CIndU patients.
    • Evaluar la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para mejorar los umbrales de provocación y el prurito generado por el test de provocación en cada subtipo de CIndU.
    • Evaluar la eficacia de diferentes pautas posológicas de CDX-0159, en comparación con un placebo, para conseguir un test de provocación negativo y mejorar el picor generado por el test en todos los pacientes con CIndU, sumando los dos subtipos.
    • Evaluar el perfil toxicológico de las diferentes pautas posológicas de CDX-0159,
    en comparación con un placebo, en cada uno de los subtipos de CIndU y en toda la muestra de pacientes, sumando los dos subtipos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females, >/= 18 years of age.
    2. Diagnosis of ColdU or SD >/= 3 months.
    3. Diagnosis of chronic ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
    a.The presence of recurrent pruritic wheals with or without angioedema for >/= 6 weeks at any time prior to Visit 1 despite the use of H1 antihistamines.
    b.Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
    c.UCT of < 12 during the 14 days prior to treatment.
    4. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
    5. Willing and able to complete a daily symptom electronic diary and comply with study visits.
    1. Hombres y mujeres, >/= 18 años de edad.
    2. Diagnóstico de ColdU o SD >/= 3 meses.
    3. Diagnóstico de ColdU crónico o SD a pesar del uso de un régimen estable de antihistamínico H1 no sedante de segunda generación definido por:
    a. La presencia de ronchas pruriginosas recurrentes con o sin angioedema durante >/= 6 semanas en cualquier momento antes de la Visita 1 a pesar del uso de antihistamínicos H1.
    b. En un régimen estable de antihistamínico H1 no sedante de segunda generación durante >/= 4 semanas antes del tratamiento del estudio.
    c. UCT < 12 durante los 14 días previos al tratamiento.
    4. Tanto los hombres como las mujeres en edad fértil deben aceptar usar
    anticonceptivos altamente efectivos durante el estudio y durante los 150 días posteriores al tratamiento.
    5. Dispuesto y capaz de completar un diario electrónico de síntomas y cumplir con las visitas del estudio.
    E.4Principal exclusion criteria
    1. Women who are pregnant or nursing.
    2. Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD.
    3. Active, pruritic skin condition in addition to CIndU.
    4. Medical condition that would cause additional risk or interfere with study procedures.
    5. Known HIV, hepatitis B or hepatitis C infection.
    6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
    7. History of anaphylaxis
    1. Mujeres embarazadas o lactantes.
    2. Urticaria crónica espontánea u otras formas de CIndU además de ColdU o SD.
    3. Condición cutánea activa y pruriginosa además de CIndU.
    4. Condición médica que podría causar un riesgo adicional o interferir con los procedimientos del estudio.
    5. Infección conocida por VIH, hepatitis B o hepatitis C.
    6. Vacunación (vacuna activa) dentro de los 2 meses anteriores al tratamiento del estudio (los sujetos deben aceptar evitar la vacunación durante el estudio). Se permiten las vacunas inactivadas, como la inyección contra la influenza estacional o vacuna contra el COVID-19.
    7. Historial de anafilaxia
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion (%) of patients with a negative provocation test at Week 12 in the ColdU subtype cohort
    oFor ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min after provocation using TempTest®
    •Proportion (%) of patients with a negative provocation test at Week 12 in the SD subtype cohort
    oFor SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min after provocation using the FricTest®
    •Proporción (%) de pacientes con una prueba de provocación negativa en la semana 12 en la cohorte del subtipo ColdU
    oPara los pacientes con ColdU, una prueba de provocación negativa se define como la ausencia de habones en el sitio de la provocación en los 10 minutos posteriores a la provocación con TempTest®
    •Proporción (%) de pacientes con una prueba de provocación negativa en la semana 12 en la cohorte del subtipo SD
    oPara los pacientes SD, una prueba de provocación negativa se define como la ausencia de habones en el sitio de provocación en los 10 minutos posteriores a la provocación con FricTest®
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    •Mean change from baseline to Week 12 in CTT in the ColdU subtype cohort
    •Mean change from baseline to Week 12 in CFT in the SD subtype cohort
    •Mean change from baseline to Week 12 in WI-NRSprovo in the ColdU subtype cohort
    •Mean change from baseline to Week 12 in WI-NRSprovo in the SD subtype cohort
    •Proportion (%) of patients with a negative provocation test at Week 12 in the combined CIndU subtype cohorts
    •Mean change from baseline to Week 12 in WI-NRSprovo in the combined CIndU subtype cohorts
    •Proportion (%) of patients experiencing TEAEs over the 20-week treatment period by subtype cohort and in the combined CIndU subtype cohorts
    •Cambio medio desde el inicio hasta la semana 12 en CTT en la cohorte del subtipo ColdU
    •Cambio medio desde el inicio hasta la semana 12 en CFT en la cohorte del subtipo SD
    •Cambio medio desde el inicio hasta la semana 12 en WI-NRSprovo en la cohorte del subtipo ColdU
    •Cambio medio desde el inicio hasta la semana 12 en WI-NRSprovo en la cohorte del subtipo SD
    •Proporción (%) de pacientes con una prueba de provocación negativa en la semana 12 en las cohortes combinadas de subtipos de CIndU
    •Cambio medio desde el inicio hasta la semana 12 en WI-NRSprovo en las cohortes combinadas de subtipos de CIndU
    •Proporción (%) de pacientes que experimentaron eventos adversos surgidos durante el tratamiento (TEAE) durante el período de tratamiento de 20 semanas por subtipo de cohortes y en las cohortes de subtipos de CIndU combinadas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    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 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) 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 trial3
    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 EEA75
    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
    South Africa
    United States
    Estonia
    Poland
    Bulgaria
    Spain
    Germany
    Belgium
    Georgia
    Hungary
    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
    Última Visita del Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 180
    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)
    Hospital standard of care.
    Según el estandar de tratamiento del hospital.
    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 Decision2022-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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