Clinical Trials Register

Summary
EudraCT Number:	2018-004614-18
Sponsor's Protocol Code Number:	I6T-MC-AMAM
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-07-04
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-004614-18

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease

Estudio de fase 3, multicéntrico, aleatorizado, con enmascaramiento doble, comparativo con un placebo y un tratamiento activo y sin re-aleatorización para evaluar la eficacia y la seguridad de mirikizumab en pacientes con enfermedad de Crohn activa de moderada a grave

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Estudio para evaluar la eficacia y la seguridad de mirikizumab en pacientes con enfermedad de Crohn activa

A.3.2

Name or abbreviated title of the trial where available

VIVID-1

A.4.1

Sponsor's protocol code number

I6T-MC-AMAM

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Lilly S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly Cork Ltd
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Island House, Eastgate Road, Eastgate Business Park
B.5.3.2	Town/ city	Little Island
B.5.3.3	Post code	.
B.5.3.4	Country	Ireland
B.5.6	E-mail	ensayosclinicos@lilly.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MIRIKIZUMAB
D.3.2	Product code	LY3074828
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MIRIKIZUMAB
D.3.9.1	CAS number	1884201-71-1
D.3.9.2	Current sponsor code	LY3074828
D.3.9.3	Other descriptive name	MIRIKIZUMAB
D.3.9.4	EV Substance Code	SUB177588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MIRIKIZUMAB
D.3.2	Product code	LY3074828
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Mirikizumab
D.3.9.1	CAS number	1884201-71-1
D.3.9.2	Current sponsor code	LY3074828
D.3.9.3	Other descriptive name	MIRIKIZUMAB
D.3.9.4	EV Substance Code	SUB177588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	STELARA 130 mg concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	USTEKINUMAB
D.3.9.1	CAS number	815610-63-0
D.3.9.3	Other descriptive name	USTEKINUMAB
D.3.9.4	EV Substance Code	SUB27761
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Stelara 90 mg solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	USTEKINUMAB
D.3.9.1	CAS number	815610-63-0
D.3.9.3	Other descriptive name	USTEKINUMAB
D.3.9.4	EV Substance Code	SUB27761
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MIRIKIZUMAB
D.3.2	Product code	LY3074828
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MIRIKIZUMAB
D.3.9.1	CAS number	1884201-71-1
D.3.9.2	Current sponsor code	LY3074828
D.3.9.3	Other descriptive name	MIRIKIZUMAB
D.3.9.4	EV Substance Code	SUB177588
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderately to severely active Crohn’s disease

Enfermedad de Crohn activa de moderada a grave

E.1.1.1

Medical condition in easily understood language

Crohn’s disease

Enfermedad de Crohn

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate whether treatment with mirikizumab is superior to placebo as assessed by endoscopic response at Week 52 and clinical remission by PRO at Week 52

Evaluar si el tratamiento con mirikizumab es superior al placebo desde el punto de vista de la respuesta endoscópica en la semana 52 y la remisión clínica en la semana 52 de acuerdo con los RPP.

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic response at Week 12
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in clinical remission by PRO at Week 12
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic remission at Week 52
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in corticosteroid-free clinical remission by PRO or endoscopic remission at Week 52
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in the stability of clinical remission by PRO through Week 52
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in the durability of endoscopic response at Week 52
- To evaluate whether mirikizumab is superior to ustekinumab in achieving endoscopic response at Week 52
- To evaluate whether mirikizumab is noninferior to ustekinumab in clinical remission by CDAI at Week 52

-Comp. la eficacia del tratamiento con mirikizumab (miri) vs. placebo según la respuesta endoscópica en la sem. 12.
-Comp. la eficacia del tratamiento con miri vs. placebo según la remisión clínica en la sem. 12 de acuerdo con los RPP.
-Comp. la eficacia del tratamiento con miri vs. placebo según la remisión endoscópica en la sem. 52.
-Comp. la eficacia del tratamiento con miri vs. placebo según la remisión clínica sin admin. de corticoesteroides en función de los RPP o de la remisión endoscópica en la sem. 52.
-Comp. la eficacia del tratamiento con miri vs. placebo según la estabilidad de la remisión clínica hasta la sem. 52, en función de los RPP.
-Comp. la eficacia del tratamiento con miri vs. placebo según la duración de la remisión endoscópica en la sem. 52.
-Evaluar si miri es superior a ustekinumab según la consecución de la respuesta endoscópica en la sem. 52.
-Evaluar si miri no es inferior a ustekinumab según la remisión clínica de acuerdo con el CDAI en la sem. 52.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Diagnosis of CD for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
• If female, subject must meet the contraception recommendations

• Diagnóstico de EC al menos 3 meses antes del período inicial.
• Diagnóstico confirmado de EC moderada a grave, de acuerdo con la frecuencia de las deposiciones (FD), la puntuación relativa al dolor abdominal (DA) y la SES-CD.
• Intolerancia, pérdida de respuesta o respuesta insuficiente (demostradas) al tratamiento convencional o biológico para la EC.
• Las mujeres deben cumplir los requisitos relativos a las medidas anticonceptivas.

E.4

Principal exclusion criteria

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome
• Have a stoma or ostomy
• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
• Have ever received any monoclonal antibodies binding IL-23

• Presentar en la actualidad diagnóstico de colitis ulcerosa, enfermedad inflamatoria intestinal inclasificable (EII-IN) (anteriormente denominada “colitis indeterminada”), absceso abdominal o perianal o síndrome del intestino corto.
• Presentar un estoma u ostomía.
• Haberse sometido a resección intestinal en el transcurso de los 6 meses anteriores al período inicial, o a cualquier tipo de cirugía intra o extraabdominal en el transcurso de los 3 meses anteriores a dicho período.
• Haber recibido anteriormente cualquier anticuerpo monoclonal dirigido a la IL-23.

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of Participants Achieving Endoscopic Response Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score [Time Frame: Week 52]
2. Percentage of Participants Achieving Clinical Remission Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP) [Time Frame: Week 52]

1. Porcentaje de pacientes que alcancen la respuesta endoscópica de acuerdo con la puntuación endoscópica simple total para la enfermedad de Crohn (SES-CD) (intervalo de tiempo: semana 52).
2. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con los resultados percibidos por el paciente (RPP) relativos a la frecuencia de las deposiciones (FD) y el dolor abdominal (DA) (intervalo de tiempo: semana 52).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 52

Semana 52

E.5.2

Secondary end point(s)

3. Percentage of Participants Achieving Endoscopic Remission Endoscopic remission based on SES-CD total score [Time Frame: Week 52]
4. Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free Clinical remission by PRO based on SF and AP and endoscopic remission based on SES-CD total score [Time Frame: Week 52]
5. Percentage of Participants Achieving Clinical Remission Clinical remission by PRO is based on SF and AP [Time Frame: Week 12]
6. Percentage of Participants Achieving Clinical Remission Clinical remission based on CDAI [Time Frame: Week 52]
7. Change from Baseline in C-Reactive Protein Change from baseline in C-Reactive Protein [Time Frame: Baseline, Week 52]
8. Change from Baseline in Fecal Calprotectin Change from baseline in fecal calprotectin [Time Frame: Baseline, Week 52]
9. Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn’s Disease
Percentage of participants with EIMs of Crohn’s Disease [Time Frame: Week 52]
10. Percentage of Participants with Fistulae Response Percentage of participants with fistulae response [Time Frame: Week 52]
11. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab
PK: AUC of mirikizumab [Time Frame: Baseline through Week 52]
12. Change from Baseline in Health Related Quality of Life Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time Frame: Baseline, Week 52]

3. Porcentaje de pacientes que alcancen la remisión endoscópica de acuerdo con la puntuación total SES-CD (intervalo de tiempo: semana 52).
4. Porcentaje de pacientes que alcancen la remisión clínica o endoscópica de entre los que habían alcanzado la remisión clínica sin la administración de corticoesteroides (de acuerdo con los RPP relativos a la FD y al DA) y la remisión endoscópica (de acuerdo con la puntuación total SES-CD) (intervalo de tiempo: semana 52).
5. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con los RPP relativos a la FD y el DA (intervalo de tiempo: semana 12).
6. Porcentaje de pacientes que alcancen la remisión clínica de acuerdo con el CDAI (intervalo de tiempo: semana 52).
7. Variación respecto al período inicial en la concentración de proteína C-reactiva (intervalo de tiempo: período inicial, semana 52).
8. Variación respecto al período inicial en la concentración de calprotectina fecal (intervalo de tiempo: período inicial, semana 52).
9. Porcentaje de participantes con manifestaciones extraintestinales (MEI) de la enfermedad de Crohn.
Porcentaje de participantes con MEI de la enfermedad de Crohn (intervalo de tiempo: semana 52).
10. Porcentaje de participantes con respuesta de la fístula (intervalo de tiempo: semana 52).
11. Farmacocinética (FC): Área bajo la curva (ABC) de concentración-tiempo de mirikizumab; FC: ABC de mirikizumab (intervalo de tiempo: desde el período inicial hasta la semana 52).
12. Variación respecto al período inicial en la calidad de vida relacionada con la salud de acuerdo con la puntuación del cuestionario sobre la enfermedad inflamatoria intestinal (IBDQ) (intervalo de tiempo: período inicial, semana 52).

E.5.2.1

Timepoint(s) of evaluation of this end point

secondary endpoint [3, 4, 6, 9, 10] Timepoints: Week 52
secondary endpoint [5] Timepoints: Week 12
secondary endpoint [7, 8, 11, 12] Timepoints: Baseline - Week 52

Criterio secundario de valoración [3, 4, 6, 9, 10] Puntos temporales: semana 52
Criterio secundario de valoración [5] Puntos temporales: semana 12
Criterio secundario de valoración [7, 8, 11, 12] Puntos temporales: período inicial – semana 52

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Ustekinumab

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

294

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

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

Argentina

Australia

Austria

Belgium

Brazil

Canada

China

Croatia

Czech Republic

Denmark

France

Germany

Hungary

Israel

Italy

Japan

Korea, Republic of

Latvia

Lithuania

Malaysia

Mexico

Netherlands

Poland

Romania

Russian Federation

Serbia

Slovakia

Spain

Sweden

Switzerland

Taiwan

Turkey

Ukraine

United Kingdom

United States

E.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1045

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

520

F.4.2.2

In the whole clinical trial

1100

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)

Participants who complete Study I6T-MC-AMAM (AMAM) through Visit 17 will be given the option to enroll in Study I6T-MC-AMAX (AMAX) if they are eligible. Participants who do not meet enrollment criteria for Study AMAX or who do not choose to participate in Study AMAX will return for two post-treatment follow-up visits in Study AMAM. The first such follow-up visit will be 4 weeks after the last dose (V801). The second such follow-up visit will be from 12 to 16 weeks after the last dose (V802).

Los participantes que completen la visita 17 del estudio I6T-MC-AMAM (AMAM) y se consideren idóneos tendrán la opción de participar en el estudio I6T-MC-AMAX (AMAX). Los que no cumplan los criterios de reclutamiento de AMAX o decidan no participar realizarán las dos visitas de seguimiento post tratamiento de AMAM, la primera de las cuales tendrá lugar 4 semanas tras la última dosis (V801). La segunda visita de seguimiento se llevará a cabo entre 12 y 16 semanas después de la última dosis (V802).

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-04

P. End of Trial
P.	End of Trial Status	Completed

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