| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Aggressive and Indolent B-cell Malignancies |
| neoplasias linfoides B agresivas e indolentes |
|
| E.1.1.1 | Medical condition in easily understood language |
| Phase II Signal Finding Study in B-Cell Malignancies |
| Estudio de fase II de búsqueda de neoplasias linfoides B agresivas e indolentes. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061275 |
| E.1.2 | Term | Mantle cell lymphoma |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10008976 |
| E.1.2 | Term | Chronic lymphocytic leukemia |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 24.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10085128 |
| E.1.2 | Term | Follicular lymphoma |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10058728 |
| E.1.2 | Term | Richter's syndrome |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. To evaluate the safety and tolerability of zilovertamab vedotin
2. To evaluate the safety and tolerability of zilovertamab vedotin in combination with nemtabrutinib
3. To evaluate zilovertamab vedotin with respect to objective response rate
4. To evaluate zilovertamab vedotin in combination with nemtabrutinib with respect to objective response rate |
1.Evaluar la seguridad y la tolerabilidad de zilovertamab vedotina.
2.Evaluar la seguridad y la tolerabilidad de zilovertamab vedotina en combinación con nemtabrutinib.
3.Evaluar zilovertamab vedotina en cuanto a la tasa de respuestas objetivas
4.Evaluar zilovertamab vedotina en combinación con nemtabrutinib en cuanto a la tasa de respuestas objetivas. |
|
| E.2.2 | Secondary objectives of the trial |
1. To evaluate zilovertamab vedotin with respect to duration of response
2. To evaluate zilovertamab vedotin in combination with nemtabrutinib with respect to duration of response
3. To evaluate the safety and tolerability of zilovertamab vedotin |
1.Evaluar zilovertamab vedotina en cuanto a la duración de la respuesta.
2.Evaluar zilovertamab vedotina en combinación con nemtabrutinib en cuanto a la duración de la respuesta.
3.Evaluar la seguridad y la tolerabilidad de zilovertamab vedotina. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. For aggressive B-cell malignancies:
• Cohort A:
a. Has biopsy proven histologically confirmed MCL.
AND
b. Has relapsed or refractory disease after at least 2 prior systemic therapies
• Cohort B:
a. Has biopsy proven histologically confirmed RT
AND
b. Has relapsed or refractory disease after at least 1 prior systemic therapy.
• Cohort C:
a. Has biopsy proven histologically confirmed MCL
AND
b. Has relapsed or refractory disease after at least 1 prior systemic therapy, has no prior exposure to a non-covalent BTKi.
2. For indolent B-cell malignancies, Part 1:
• Cohort D:
a. Has biopsy proven histologically confirmed FL Grade 1-3A
AND
b. Has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
OR
c. Has histologically confirmed CLL
AND
d. Has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
3. For indolent B-cell malignancies, Part 2:
• Cohort E:
a. Has biopsy proven histologically confirmed FL Grade 1-3A
AND
b. Has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
• Cohort F:
a. Has histologically confirmed CLL
AND
b. Has relapsed c or refractory d disease after at least 2 prior systemic therapies and no other available therapy.
4. Disease status requirements:
• For Cohorts A and B:
a. Has PET positive disease verified by BICR at Screening
b. Has radiographically measurable disease per the Lugano Response Criteria, as assessed locally by the investigator and confirmed by BICR.
• For Cohort C:
a. Has PET positive assessed locally by investigator at Screening, defined as 4-5 on the Lugano 5-point scale.
b. Has radiographically measurable disease per the Lugano Response
Criteria
• For Cohort D and E:
a. Has radiographically measurable disease per the Lugano Response Criteria, OR
b. Has PET positive disease verified by BICR at Screening defined as 4-5
on a 5-point scale.
• For Cohorts D, and F: symptomatic disease that mandates treatment
• For Cohorts D (FL) and E: clinical features that mandate treatment such as high tumor burden according to the modified GELF criteria.
5. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
6. Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening.
7. Is male or female, from 18 years of age inclusive, at the time of providing informed consent.
8. If male, agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
- Zilovertamab vedotin: 110 days
- Nemtabrutinib: 12 days
• Refrains from donating sperm
PLUS either:
• Abstains from heterosexual intercourse as their preferred and usual lifestyle and agrees to remain abstinent OR
• Uses contraception unless confirmed to be azoospermic
9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Not a WOCBP
OR
• A WOCBP and:
- Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle. The length of time required to continue contraception for each study intervention is as follows:
◦ Zilovertamab vedotin: 50 days
◦ Nemtabrutinib: 30 days
- Has a negative highly sensitive pregnancy test within 24 hours for urine and 72 hours for serum before the first dose of study intervention with zilovertamab vedotin and at least 30 days after
study intervention with nemtabrutinib.
- Abstains from breastfeeding during the study intervention period and for at least 20 days after study intervention.
- Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
10. The participant has provided documented informed consent for the study. May also provide consent for FBR.
11. For Cohorts A, B, C, D and E: Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated has been provided. Archival tissue must have been collected <5 years prior to Screening.
12. Have an ECOG performance status of 0 to 2 assessed within 7 days before C1D1.
13. Prior exposure to MMAE-containing drugs is allowed.
14. Have adequate organ function. Specimens must be collected and reviewed within 7 days before the start of study intervention. |
1.Neoplasias malignas de linfocitos B agresivas
Cohorte A: LCM confirmado por biopsia según clasificación de neoplasias de los tejidos hematopoyético y linfático de la OMS y enf. recidivantea o resistenteb después de al menos 2 ttos sistémicos previos, incluido un iBTK, y se administró terapia CAR-T o no se es apto para recibirla por motivos clínicos, logísticos o elección del participante.
Cohorte B: TR confirmada por biopsia según clasificación de neoplasias de los tejidos hematopoyético y linfático y Enf. recidivantea o resistenteb después de al menos 1 tto sistémico previo
Cohorte C: LCM confirmado por biopsia según la clasificación de neoplasias de los tejidos hematopoyético y linfático de la OMS y enf. recidivantea o resistenteb después de al menos 1 tto previo, sin exposición a iBTK no covalente
2.Neoplasias malignas de linfocitos B de crecimiento lento, parte 1 (optimización de pauta): Cohorte D: LF de grado 1-3A confirmado por biopsia según clasificación de neoplasias de los tejidos hematopoyético y linfático de la OMS y enf. recidivantea o resistenteb después de al menos 2 ttos y ningún otro tto disponible o LLC confirmada según criterios iwCLL de 2018 y Enf. recidivantec o resistented después de al menos 2 ttos y ningún otro tto disponible
3.Neoplasias malignas de linfocitos B de crecimiento lento, parte 2 (ampliación a efectos de eficacia): Cohorte E: LF de grado 1-3A confirmado por biopsia según clasificación de neoplasias de los tejidos hematopoyético y linfático de la OMS y enf. recidivantea o resistenteb después de al menos 2 y ningún otro tto disponible. Cohorte F:LLC confirmada según criterios del iwCLL de 2018 y Enf. recidivantec o resistented después de al menos 2 ttos y ningún otro tto disponible
4.Estado de la enf: En cohortes A y B: Enf. con PET positiva, verificada con ECIE en período de selección, definida como 4-5 en escala de 5 puntos de Lugano. Presencia de enf. mensurable radiológicamente conforme a criterios de respuesta de Lugano, según la evaluación del invest. y confirmada por ECIE. Cohorte C: Enf. con PET positiva, según evaluación del investigador en período de selección, definida como 4-5 en escala de 5 puntos de Lugano. Presencia de enf. mensurable radiológicamente conforme a criterios de respuesta de Lugano, según evaluación del investigador, con al menos 1 lesión ganglionar (no irradiada) de ≥1,5 cm de eje mayor, con independencia de la longitud del eje menor, o una lesión extraganglionar de ≥1,0 cm de eje mayor y menor. En la cohorte D (LF) y E: Presencia de enf. mensurable radiológicamente conforme a criterios de respuesta de Lugano, según evaluación local y confirmada por ECIE, con al menos 1 lesión ganglionar (no irradiada) de ≥1,5 cm de eje mayor, con independencia de la longitud del eje menor, Y/O una lesión extraganglionar de ≥1,0 cm de eje mayor y menor o Enf. con PET positiva, verificada mediante una ECIE en período de selección, definida como 4-5 en escala de 5 puntos. En las cohortes D (LLC), F y G: enf. sintomática que requiere tto según criterios del iwCLL. Cohortes D (LF) y E: características clínicas que exijan tto.
5.Pacientes positivos para HBsAg si han recibido tto antiviral contra el VHB durante al menos 4 semanas y tengan carga viral indetectable
6.Pacientes con antecedentes de inf. por VHC si la carga viral del VHC es indetectable.
7.Varón o mujer mayor de 18 años para otorgar el consentimiento informado.
8.Si es varón, se compromete durante la intervención y el tiempo necesario para eliminar cada intervención del estudio después de la última dosis. tiempo de la anticoncepción: Zilovertamab vedotina: 110 días, Nemtabrutinib: 12 días, abstenerse a donar semen y mantener relaciones y compromiso de mantener abstinencia o uso de anticonceptivos, a menos que se confirme azoospermia
9. Podrán participar mujeres no embarazadas ni en período de lactancia y que cumplan al menos 1 de estas: No es una mujer en edad fértil, es una mujer en edad fértil y usa un método anticonceptivo muy eficaz, con baja dependencia de la usuaria o practica abstinencia de relaciones, durante la intervención y durante el tiempo necesario para eliminar cada intervención del estudio después de recibir la última dosis y se compromete a no donar óvulos a otras personas ni congelarlos o conservarlos durante este período. Tiempo de la anticoncepción es: Zilovertamab vedotina: 50 días, Nemtabrutinib: 30 días.
10.El participante otorgará su consentimiento informado y para investigaciones biomédicas futuras
11.Cohortes A, B, C, D (LF) y E: El participante proporcionará una muestra de tejido tumoral de archivo o biopsia reciente. El tejido de archivo deberá haberse obtenido menos de 5 años antes.
12. Estado funcional ECOG de 0 a 2 determinado en 7 días previos al D1C1.
13. Permitida la exposición previa a fármacos que contengan MMAE
14. Presencia de función orgánica adecuada. Las muestras deberán obtenerse y analizarse 7 días previos al comienzo del estudio. |
|
| E.4 | Principal exclusion criteria |
1. Has received solid organ transplant at any time.
2. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina (<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication.
3. In participants with prior allo-SCT, acute GVHD or ongoing evidence of chronic GVHD manifesting as Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea or requiring systemic immunosuppression for treatment/prophylaxis for their GVHD.4. Has pericardial effusion or clinically significant pleural effusion.
5. Has ongoing Grade >1 peripheral neuropathy.
6. Has a demyelinating form of Charcot-Marie-Tooth disease.
7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
8. Participants with FL who have transformed to a more aggressive typeof lymphoma.
9. Has received prior therapy with a ROR1-directed therapy.
10. Has contraindication to any of the study intervention components.
11. Has received prior systemic anticancer therapy, including investigational agents, within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (small molecules like kinase inhibitors) prior to the first dose of study intervention.
12. Has received prior radiotherapy within 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities.
A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
13. Has ongoing corticosteroid therapy exceeding 30 mg daily of prednisone equivalent.
If taken, prednisone equivalent dosing of ≤30 mg daily must have been stable for at least 4 weeks prior to C1D1 unless corticosteroid treatment is required for lymphoma symptom control prior to C1D1. In that case, up to 100 mg per day of prednisone equivalent can be given for up to 5 days, and tumor assessments must have been completed prior to the start of corticosteroid treatment.
14. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
15. Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to C1D1 or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer until <30 days after the last IMP dose.
16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
17. Has known active CNS lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease) and clinical remission.
18. Has an active infection requiring systemic therapy.
19. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority.
20. Active HBV or HCV infection.
21. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
22. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Other Exclusions (Cohort C):
23. Has QTc prolongation (defined as a QTcF >450 msecs) or other significant ECG abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
24. Is currently being treated with the following drugs:
- CYP 2C9 substrates with a narrow therapeutic index (such as warfarin , phenytoin)
- CYP 2C8 substrates with a narrow therapeutic index (such as paclitaxel )
- CYP 2C19 substrates with a narrow therapeutic index (such as Smephenytoin)
- CYP 2D6 substrates with a narrow therapeutic index (such as thioridazine, pimozide)
- P-gp substrates with a narrow therapeutic index (such as digoxin)
25. Has any clinically significant gastrointestinal abnormalities that might alter absorption. |
1.Recepción de un trasplante de órgano sólido en cualquier momento.
2.Enfermedad cardiovascular clínicamente importante: accidente cerebrovascular/ictus, infarto de miocardio, angina de pecho inestable <6 meses antes de la inclusión, insuficiencia cardíaca congestiva o arritmia cardíaca grave con necesidad de medicación.
3.En participantes con un alo-TCM previo, EICH aguda o signos persistentes de EICH crónica que se manifiestan como bilirrubina sérica de grado ≥2, afectación cutánea de grado ≥3 o diarrea de grado ≥3 o necesidad de inmunodepresión sistémica como tratamiento o profilaxis de la EICH.
4.Presencia de derrame pericárdico o derrame pleural.
5.Presencia de neuropatía periférica de grado >1.
6.Presencia de una forma desmielinizante de la enfermedad de Charcot-Marie-Tooth.
7.Antecedentes de una segunda neoplasia maligna, a menos que se haya completado un tratamiento potencialmente curativo sin signos de neoplasia maligna durante dos años.
8.Presencia de un LF que se ha transformado en un tipo más agresivo de linfoma.
9.Recepción de tratamiento previo con un tratamiento dirigido contra ROR1.
10.Contraindicación de cualquiera de los componentes de la intervención del estudio.
11. Recepción de un tratamiento antineoplásico sistémico previo, incluidos fármacos experimentales, en el período equivalente a 5 semividas o 4 semanas o 2 semanas antes de la primera dosis de intervención del estudio.
12. Recepción de radioterapia en los 28 días previos al comienzo de la intervención del estudio. Los participantes deberán haberse recuperado de toda toxicidad relacionada con la radioterapia.
13. Tratamiento en curso con corticosteroides que supere los 30mg al día de un equivalente de prednisona.
En caso de tomarse, la dosis del equivalente de prednisona de ≤30mg al día deberá haberse mantenido estable durante al menos 4 semanas antes del D1C1 a menos que se precise dicho tratamiento para controlar los síntomas del linfoma antes del D1C1. En tal caso, podrán administrarse hasta 100mg al día de un equivalente de prednisona durante un máximo de 5 días y las evaluaciones tumorales deberán haberse realizado antes del inicio del tratamiento con corticosteroides.
14. Vacuna de microorganismos vivos o vivos atenuados en los 30 días previos a la primera dosis de intervención del estudio. Se permite la administración de vacunas inactivadas.
15. Recepción de un inhibidor o inductor potente de la enzima CYP3A4 en los 7 días previos al D1C1 o necesidad prevista de uso crónico de un inhibidor o inductor potente de la enzima CYP3A4 hasta menos de 30 días después de la última dosis del PEI.
16. Participación activa o pasada en un estudio de un fármaco en investigación o uso de un dispositivo en investigación en las cuatro semanas previas a la administración de la primera dosis de la intervención del estudio.
17. Presencia de afectación activa del SNC por el linfoma (ya conocida o recién determinada). Los candidatos con afectación del SNC previa podrán participar si dicha afectación está en remisión radiológica, citológica y clínica.
18. Presencia de una infección activa con necesidad de tratamiento sistémico.
19. Antecedentes conocidos de infección por el VIH. No será necesario realizar pruebas de VIH a menos que lo exijan las autoridades sanitarias locales.
20. Infección activa por el VHB o VHC.
21. Antecedentes o datos presentes de cualquier proceso, tratamiento, anomalía analítica u otra circunstancia que, en opinión del investigador responsable del tratamiento, pueda confundir los resultados del estudio o dificultar la participación durante la totalidad del estudio, haciendo que la participación no sea lo más conveniente para el posible participante.
22. Presencia de un trastorno psiquiátrico o por abuso de sustancias que podría dificultar la capacidad del participante para colaborar en el cumplimiento de los requisitos del estudio.
Otros criterios de exclusión (cohorte C)
23. Presencia de prolongación del QTc (definida como un QTcF >450 ms) u otras anomalías electrocardiográficas significativas, como bloqueo AV de segundo grado de tipo II, bloqueo AV de tercer grado o bradicardia (frecuencia ventricular inferior a 50 latidos/min).
24. Tratamiento presente con los siguientes fármacos: Sustratos de CYP 2C9 con un índice terapéutico estrecho (como warfarina o fenitoína), Sustratos de CYP 2C8 con un índice terapéutico estrecho (como paclitaxel), Sustratos de CYP 2C19 con un índice terapéutico estrecho (como S-mefenitoína) Sustratos de CYP 2D6 con un índice terapéutico estrecho (como tioridazina o pimozida) y sustratos de la gp-P con un índice terapéutico estrecho (como digoxina).
25. Presencia de cualquier anomalía digestiva clínicamente significativa que pueda alterar la absorción. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1.Percentage of participants with ≥1 adverse event (AE) [Cohorts C and D]
2. Percentage of participants discontinuing from study therapy due to AE (Cohorts C and D)
3. Percentage of participants with dose-limiting toxicity (DLT) [Cohort C]
4. Objective response rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR)
5. ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as assessed by investigator |
1. Porcentaje de participantes con > 1 de acontecimientos adversos (cohortes C y D)
2. Porcentaje de pacientes discontinuados en el estudio debido a los acontecimientos adversos (cohortes C y D)
3. Porcentaje de pacientes con toxicidad limitante de la dosis (Cohorte C).
4. Tasa de respuesta objetiva (ORR) según los criterios de respuesta de Lugano según lo evaluado por una revisión central independiente
5. Tasa de respuesta objetiva (ORR) según los criterios del Workshop internacional sobre la leucemia linfocítica crónica (iwCLL) evaluados por el investigador. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 57 months
2. Up to approximately 57 months
3. Up to approximately 57 months
4. Up to approximately 57 months
5. Up to approximately 57 months |
1. hasta 57 meses aproximadamente.
2. hasta 57 meses aproximadamente
3. hasta 57 meses aproximadamente
4. hasta 57 meses aproximadamente
5. hasta 57 meses aproximadamente |
|
| E.5.2 | Secondary end point(s) |
1. Duration of response (DOR) per Lugano Response Criteria as assessed
by BICR
2. DOR per iwCLL Criteria as assessed by investigator
3. Percentage of participants with ≥1 AE (Cohorts A, B, E, and F)
4. Percentage of participants discontinuing from study therapy due to AE
(Cohorts A, B, E, and F) |
1. Duración de respuesta conforme a los criterios de respuesta de Lugano, según una ECIE
2. Duración de respuesta por iwCLL evaluados por el investigador
3. Porcentaje de participantes con > 1 acontencimientos adversos (Cohorte A,B,E y F)
4.Porcentaje de participantes que discontinúan la terapia debido a los acontecimientos adversos (Cohorte A,B,E y F) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 57 months
2. Up to approximately 57 months
3. Up to approximately 57 months
4. Up to approximately 57 months |
1. hasta 57 meses aproximadamente
2. hasta 57 meses aproximadamente
3. hasta 57 meses aproximadamente
4. hasta 57 meses aproximadamente |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Patient reported outcome; Anti-Drug Antibody testing, Receptor occupancy |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 26 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Brazil |
| Canada |
| Chile |
| Israel |
| Korea, Republic of |
| Malaysia |
| Peru |
| Singapore |
| United States |
| Estonia |
| Poland |
| Sweden |
| Spain |
| Czechia |
| Germany |
| Italy |
| Ireland |
| Portugal |
| Russian Federation |
| Turkey |
| United Kingdom |
|
| E.8.7 | Trial 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 |
| última visita ultimo paciente |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 4 |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | 6 |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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