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    Summary
    EudraCT Number:2020-004775-40
    Sponsor's Protocol Code Number:APD334-202EU
    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:2021-09-28
    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 number2020-004775-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
    Estudio multicéntrico, aleatorizado, doble ciego y de grupos paralelos para evaluar la eficacia y seguridad del etrasimod por vía oral como tratamiento de inducción y mantenimiento para enfermedad de Crohn activa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease
    Un estudio que evalúa la eficacia y seguridad de Etrasimod en el tratamiento de pacientes con enfermedad de Crohn activa de moderada a grave.
    A.3.2Name or abbreviated title of the trial where available
    CULTIVATE
    A.4.1Sponsor's protocol code numberAPD334-202EU
    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 SponsorArena 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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointTracy Angelly
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number349372310102980
    B.5.6E-mailtangelly@arenapharm.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 nameEtrasimod
    D.3.2Product code APD334
    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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 nameEtrasimod
    D.3.2Product code APD334
    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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease a form of inflammatory bowel disease.
    La enfermedad de Crohn es una forma de enfermedad inflamatoria intestinal.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Substudy A - Phase 2 (SSA-P2) (optional)
    •To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD)
    Substudy 1 - Phase 2b - (SS1-P2b)
    • To evaluate the dose-response relationship of 2 doses of etrasimod vs placebo as induction therapy in subjects with moderately to severely active CD
    • To select an oral etrasimod dose(s), based on efficacy and safety for continued development
    Substudy 2 – Induction (Phase 3) (SS2-I)
    • To evaluate the efficacy of the selected etrasimod dose vs placebo as induction therapy in subjects with moderately to severely active CD
    Substudy 3 – Maintenance (Phase 3) (SS3-M)
    • To evaluate the efficacy of etrasimod vs placebo as maintenance therapy in subjects with moderately to severely active CD
    Substudy 4 – Long-Term Extension (SS4-E)
    • To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to severely active CD
    Subestudio A–Fase 2 (opcional)
    Evaluar la seguridad, la tolerabilidad y la eficacia de 2 dosis de etrasimod como tratamiento de inducción en sujetos con enfermedad de Crohn (EC) activa de moderada a grave.
    Subest 1–Fase 2b
    Evaluar la relación dosis respuesta de 2 dosis de etrasimod vs placebo como tratamiento de inducción en sujetos con EC activa de moderada a grave.
    Seleccionar la(s) dosis por vía oral de etrasimod, en función de la eficacia y la seguridad, para continuar con su desarrollo.
    Subest 2 – Inducción (fase 3)
    Evaluar la eficacia de la dosis seleccionada de etrasimod vs placebo como tratamiento de inducción en sujetos con EC activa de moderada a grave.
    Subest 3 – Mantenimiento (fase 3)
    Evaluar la eficacia de etrasimod vs placebo como tratamiento de mantenimiento en sujetos con EC activa de moderada a grave.
    Subest 4 – Extensión a largo plazo
    Evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo de etrasimod en sujetos con EC activa de moderada a grave.
    E.2.2Secondary objectives of the trial
    SSA (optional)
    long-term safety, tolerability & efficacy of etrasimod in subjects with moderately to severely active CD
    PK effects of etrasimod as induction & maintenance therapy in subjects with moderately to severely active CD
    SS1
    Long-Term safety, tolerability & efficacy of etrasimod in subjects with moderately to severely active CD
    SS2
    safety & tolerability of selected etrasimod Ph3 dose vs placebo as induction therapy in subjects with moderately to severely active CD
    SS3
    efficacy of etrasimod on sustained clinical remission & endoscopic response, endoscopic remission & corticosteroid-free clinical remission in subjects with moderately to severely active CD characterize safety & tolerability of etrasimod as maintenance therapy in subjects with moderately to severely active CD
    SS4
    Long-Term efficacy of etrasimod in subjects with moderately to severely active CD
    SSA (opcional)
    Seguridad, tolerabilidad y eficacia a largo plazo de etrasimod en sujetos con EC activa de moderada a grave.
    Efectos farmacocinéticos y farmacodinámicos de etrasimod como tratamiento de inducción y de mantenimiento en sujetos con EC activa de moderada a grave.
    SS1
    Seguridad, tolerabilidad y eficacia a largo plazo de etrasimod en sujetos con EC activa de moderada a grave
    SS2
    Seguridad y tolerabilidad de la dosis seleccionada de fase III de etrasimod vs placebo como tratamiento de inducción en sujetos con EC activa de moderada a grave
    SS3
    eficacia de etrasimod sobre la remisión clínica mantenida y la respuesta endoscópica, la remisión endoscópica y la remisión clínica sin corticoesteroides en sujetos con EC activa de moderada a grave.
    Caracterizar seguridad y tolerabilidad de etrasimod como tratamiento de mantenimiento en sujetos con EC activa de moderada a grave.
    SS4
    Eficacia a largo plazo de etrasimod en sujetos con EC activa de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects 18 to 80 years of age, inclusive, at the time of consent
    2. Ability to provide written informed consent and to be compliant with the schedules of protocol assessments
    3. Have CD for ≥ 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart
    4. Have moderately to severely active CD at Screening, defined as:
    − Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, AND
    − Unweighted average worst daily abdominal pain (AP) score ≥ 2 unweighted average daily loose/watery stool frequency (SF) score ≥ 4,
    AND
    − Simple Endoscopic Score in Crohn's disease (SES-CD) of ≥ 6 or SES-CD ≥ 4 for subjects with isolated ileal disease
    5. Demonstrated inadequate response, loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD
    − Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide)
    − Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate)
    − Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
    − Integrin receptor antagonist (eg, vedolizumab)
    − Interleukin-12/-23 antagonist (eg, ustekinumab)
    6. Females of childbearing potential must be nonpregnant
    7. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
    a. A female who is not of childbearing potential must meet 1 of the following:
    − Postmenopausal, defined as no menses for 12 months without an alternative medical cause and confirmed by follicle-stimulating hormone (FSH) within postmenopausal range according to local standards
    − Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy
    b. A female who is of childbearing potential must agree to using a highly effective contraception method during treatment and for 4 weeks following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly.
    The following are considered highly effective birth control methods:
    − Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal
    − Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted
    − Intrauterine device (IUD)
    − Intrauterine hormone-releasing system (IUS)
    − Bilateral tubal occlusion
    − Vasectomized partner, provided that partner is the sole sexual partner of the FOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
    − Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study drug). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable
    c. A male must agree to using condoms during treatment and for 4 weeks following treatment
    SS3-M, SS4-E: Females and males must continue to meet contraception criterion described above
    1. Sujetos de 18 a 80 años de edad, ambos inclusive, en el momento del consentimiento.
    2. Capacidad de proporcionar consentimiento informado por escrito y de cumplir los calendarios de las evaluaciones del protocolo.
    3. Tener EC durante ≥3 meses antes de la aleatorización, que afecta como mínimo al íleon y/o colon; el diagnóstico puede haber sido confirmado en cualquier momento en el pasado por endoscopia o histopatología. La endoscopia de selección y los informes de histopatología pueden servir como documentos originales para los sujetos que no tengan informes de diagnóstico por endoscopia en su historia clínica.
    4. Tener EC activa de moderada a grave en la selección, definida como:
    - Puntuación en el Índice de Actividad de la Enfermedad de Crohn (IAEC) ≥220 y ≤450, Y
    - Puntuación media no ponderada del peor dolor abdominal (DA) diario ≥2 O puntuación media no ponderada de frecuencia de deposiciones (FD) sueltas/líquidas ≥4, Y
    - Puntuación endoscópica simple en la enfermedad de Crohn (SES-EC) ≥6 o SES-EC ≥4 para los sujetos con enfermedad de íleon aislada.
    5. Mostrar una respuesta inadecuada, pérdida de respuesta o intolerancia a ≥1 de los siguientes tratamientos para la EC (consulte el Anexo 9):
    a. Corticoesteroides orales (p. ej., prednisona [o su equivalente] o budesónida)
    b. Inmunodepresores (p. ej., azatioprina, 6-mercaptopurina, o metotrexato)
    c. Antagonistas del factor de necrosis tumoral alfa (TNFα) (p. ej., infliximab, adalimumab, certolizumab pegol o biosimilares)
    d. Antagonista de los receptores de integrinas (p. ej., vedolizumab)
    e. Antagonista de la interleucina 12/ 23 (p. ej., ustekinumab)
    6. Las mujeres en edad fértil no pueden estar embarazadas.
    7. Las mujeres deben cumplir con a o b de los siguientes criterios y los hombres deben cumplir con el criterio c para ser elegible para el estudio:
    a. Una mujer que no esté en edad fértil debe cumplir con uno de los siguientes requisitos:
    - Posmenopáusica, definida como ausencia de menstruación durante 12 meses sin una causa médica alternativa y confirmada por la hormona estimulante del folículo (FSH) dentro del rango posmenopáusico de acuerdo con los estándares locales.
    - Procedimiento de esterilización permanente, como histerectomía, salpingectomía bilateral u ooforectomía bilateral
    b. Una mujer en edad fértil debe aceptar el uso de un método anticonceptivo altamente eficaz durante el tratamiento y durante las 4 semanas posteriores al mismo, que puede lograr una tasa de fracaso de menos del 1% por año cuando se usa de manera consistente y correcta.
    Los siguientes se consideran métodos anticonceptivos altamente efectivos:
    - Anticoncepción hormonal combinada (que contiene estrógenos y progestágenos) asociada con la inhibición de la ovulación, que puede ser oral, intravaginal o transdérmica.
    - Anticoncepción hormonal de progestágeno solo asociada con la inhibición de la ovulación, que puede ser oral, inyectada o implantada.
    - Dispositivo intrauterino (DIU)
    - Sistema de liberación de hormonas intrauterinas (SIU)
    - Oclusión tubárica bilateral
    - Pareja vasectomizada, siempre que esa pareja sea la única pareja sexual del participante del ensayo FOCBP y que la pareja vasectomizada haya recibido una evaluación médica del éxito quirúrgico.
    - Abstinencia sexual (abstinencia sexual completa definida como abstenerse de relaciones heterosexuales durante todo el período de riesgo asociado con el fármaco del estudio). La fiabilidad de la abstinencia sexual debe evaluarse en relación con la duración del estudio clínico y el estilo de vida preferido y habitual del sujeto. La abstinencia periódica (calendario, sintotérmico, métodos posovulación) no es aceptable.
    c. Un hombre debe aceptar usar preservativo durante el tratamiento y durante las 4 semanas posteriores al tratamiento.
    SS3-M, SS4-E: Las mujeres y los hombres deben seguir cumpliendo con el criterio de anticoncepción descrito anteriormente.
    E.4Principal exclusion criteria
    Key exclusion criteria:
    - History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin-12/-23 antagonist, and integrin receptor antagonist)
    - Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening
    - Have functional or post-operative short-bowel syndrome (ie, have > 3 small bowel resections) or any associated complications that may require surgery or interfere with efficacy assessments
    - Had surgical treatment for intra-abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization
    - Had intestinal resection ≤ 24 weeks prior to randomization or other intra-abdominal surgeries ≤ 12 weeks prior to randomization. Subjects who have undergone previous colonic resection or ileocolectomy must have > 25 cm of colon remaining
    - Have an ileostomy or a colostomy
    - Have a serious infection requiring intravenous antibiotic(s)/medication(s) ≤ 4 weeks prior to randomization
    - Have primary or secondary immunodeficiency syndromes, history of organ transplant, history of an opportunistic infection, history of disseminated herpes simplex or herpes zoster, have or test positive for HIV, HBV, or active HCV
    - Lactating female who is breastfeeding
    1. Antecedentes de respuesta inadecuada (es decir, ausencia de respuesta principal) a ≥2 clases de fármacos biológicos comercializados para el tratamiento de la EC (es decir, antagonistas de TNFα, antagonista de la interleucina 12/ 23 y antagonista del receptor de integrina, consulte el Anexo 9).
    2. Padecer colitis ulcerosa, colitis indeterminada, colitis microscópica, colitis isquémica, colitis por radiación, colitis asociada a la enfermedad diverticular, megacolon tóxico, o colitis infecciosa activa o un resultado positivo en la prueba de la toxina Clostridioides difficile en la selección.
    3. Tener síndrome del intestino corto funcional o posoperatorio (es decir, haber tenido >3 resecciones del intestino delgado) o cualquier complicación derivada de este síndrome que pueda requerir cirugía o interferir con las evaluaciones de la eficacia.
    4. Haber recibido tratamiento quirúrgico debido a abscesos intrabdominales ≤8 semanas antes de la aleatorización, o tratamiento quirúrgico para abscesos perianales ≤4 semanas antes de la aleatorización.
    5. Haber sufrido una resección intestinal ≤24 semanas antes de la aleatorización u otras intervenciones quirúrgicas intrabdominales ≤12 semanas antes de la aleatorización. Los sujetos que se hayan sometido anteriormente a resección colónica o a ileocolectomía deben tener >25 cm de colon restante.
    6. Haberse sometido a una ileostomía o colostomía.
    7. Padecer una infección grave que requiera antibiótico(s)/medicamento(s) por vía intravenosa ≤4 semanas antes de la aleatorización.
    8. Presentar síndromes de inmunodeficiencia primaria o secundaria, antecedentes de trasplante de órganos, antecedentes de infección oportunista, antecedentes de herpes simple diseminado o de herpes zóster, resultado positivo de la prueba del virus de la inmunodeficiencia humana, el virus de la hepatitis B o el virus activo de la hepatitis C.
    9. Mujer en período de lactancia que está dando el pecho.
    E.5 End points
    E.5.1Primary end point(s)
    SSA-P2
    Portion of subjects with endoscopic response
    SS1-P2b
    Proportion of subjects with endoscopic response at Week 14
    SS2-I
    Proportion of subjects with endoscopic response at Week 14
    Proportion of subjects with clinical remission CDAI at Week 14
    SS3-M
    Proportion of subjects with clinical remission CDAI at Week 52
    Proportion of subjects with endoscopic response at Week 52
    SSA-P2
    Proporción de sujetos con respuesta endoscópica
    SS1-P2b
    Proporción de sujetos con respuesta endoscópica en la semana 14.
    SS2-I
    Proporción de sujetos con respuesta endoscópica en la semana 14.
    Proporción de sujetos con IAEC de remisión clínica en la semana 14.
    SS3-M
    Proporción de sujetos con IAEC de remisión clínica en la semana 52.
    Proporción de sujetos con respuesta endoscópica en la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14 (SSA-P2, SS1-P2b, SS2-I)
    Week 52 (SS3-M)
    Week 66 (SSA-P2)
    Semana 14 (SSA-P2, SS1-P2b, SS2-I)
    Semana 52 (SS3-M)
    Semana 66 (SSA-P2)
    E.5.2Secondary end point(s)
    SSA-P2:
    Proportion of subjects with clinical remission CDAI
    Change from baseline in SES-CD score
    Change from baseline in CDAI score
    SS1-P2b:
    Proportion of subjects with clinical remission CDAI at Week 14
    SS2-I:
    • Proportion of subjects with clinical remission PRO2 at Week 14
    • Proportion of subjects with clinical response CDAI at Week 14
    • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14
    • Proportion of subjects with endoscopic remission at Week 14
    SS3-M
    • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline (defined as Week 14 or EI-Week 6 Visit)
    • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M baseline
    • Proportion of subjects with corticosteroid-free clinical remission CDAI at Week 52 among subjects receiving corticosteroids at SS3-M baseline
    • Proportion of subjects with endoscopic remission at Week 52
    • Proportion of subjects with clinical remission PRO2 at Week 52
    SS4-E
    • Proportion of subjects with clinical remission CDAI by visit up to the end of treatment
    • Proportion of subjects with clinical remission PRO2 by visit up to the end of treatment
    SSA-P2:
    Proporción de sujetos con IAEC de remisión clínica.
    Cambio desde el inicio en la puntuación SES-EC.
    Cambio desde el inicio en la puntuación IAEC.
    SS1-P2b:
    Proporción de sujetos con el IAEC de remisión clínica en la semana 14.
    SS2-I:
    Proporción de sujetos con RCP2 de remisión clínica en la semana 14.
    Proporción de sujetos con IAEC de respuesta clínica en la semana 14.
    Proporción de sujetos con respuesta endoscópica e IAEC de remisión clínica en la semana 14.
    Proporción de sujetos con remisión endoscópica en la semana 14.
    SS3-M
    Proporción de sujetos con IAEC de remisión clínica en la semana 52 de entre los sujetos en IAEC de remisión clínica al inicio del SE3-M (definido como la visita de la semana 14 o en la visita de la semana 6 de la AI).
    Proporción de sujetos con respuesta endoscópica en la semana 52 de entre los sujetos con respuesta endoscópica al inicio del SE3-M.
    Proporción de sujetos con IAEC de remisión clínica sin corticoesteroides en la semana 52 de entre los sujetos que recibían corticoesteroides al inicio del SE3-M.
    Proporción de sujetos con remisión endoscópica en la semana 52.
    Proporción de sujetos con RCP2 de remisión clínica en la semana 52.
    SS4-E
    Proporción de sujetos con IAEC de remisión clínica por visita hasta el fin del tratamiento.
    Proporción de sujetos con RCP2 de remisión clínica por visita hasta el fin del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 14 (SS1-P2b, SS2-I)
    Week 52 (SS3-M)
    Week 66 (SSA-P2)
    Week 274 (SS4-E)
    Semana 14 (SS1-P2b, SS2-I)
    Semana 52 (SS3-M)
    Semana 66 (SSA-P2)
    Semana 274 (SS4-E)
    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    dose finding
    hallazgo de dosis
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Fase 2/3
    seameless Ph2/3
    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 EEA273
    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
    Australia
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czechia
    Denmark
    Egypt
    France
    Georgia
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Moldova, Republic of
    Netherlands
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 1107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 658
    F.4.2.2In the whole clinical trial 1265
    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
    Ninguno
    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 Decision2021-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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