Clinical Trials Register

Summary
EudraCT Number:	2018-004614-18
Sponsor's Protocol Code Number:	I6T-MC-AMAM
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-07-30
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

Italy - Italian Medicines Agency

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

Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato verso placebo e comparatore attivo, per valutare l'efficacia e la sicurezza di Mirikizumab in pazienti con malattia di Chron moderata o severa

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

Studio per valutare l'efficacia e la sicurezza di Mirikizumab in pazienti affetti da Morbo di Chron attivo

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

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/130/2020

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	IN 46285
B.5.3.4	Country	United States
B.5.6	E-mail	EU_Lilly_Clinical_Trials@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.3.9.4	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.9.4	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.1	Product name	Ustekinumab
D.3.2	Product code	[Ustekinumab]
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.3.9.2	Current sponsor code	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.1	Product name	Ustekinumab
D.3.2	Product code	[Ustekinumab]
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	USTEKINUMAB
D.3.9.1	CAS number	815610-63-0
D.3.9.2	Current sponsor code	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.9.4	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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
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

Morbo di Chron moderato o severo

E.1.1.1

Medical condition in easily understood language

Crohn’s disease

morbo di Chron

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 the clinical efficacy of mirikizumab in partecipants with Crohn's disease

Valutare l'efficacia clinica di mirikizumab nei partecipanti con Morbo di Crohn

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of mirikizumab on endoscopic and clinical improvement
- To evaluate the efficacy of mirikizumab on quality of life.
- To evaluate the efficacy of mirikizumab on biomarkers, PK, and PD

- valutare l'efficacia di mirikizumab sul miglioramento endoscopico e clinico
- Valutare l'efficacia di mirikizumab sulla qualità della vita
- Valutare l'efficacia di mirikizumab su biomarcatori, PK e PD

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Title: An Open Label Addendum to the AMAM adult study to Assess Efficacy and Safety of Mirikizumab in the Induction and Maintenance of Remission in Adolescents (15 to <18 years of age) with Moderately to Severely Active Crohn's Disease (CD).
Protocol Addendum of sub-study dated on 08Jun2020.
Objective: To evaluate the safety and efficacy of miri in adolescents with CD.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: titolo: Un addendum in aperto allo studio AMAM sugli adulti per valutare l'efficacia e la sicurezza di Mirikizumab nell'induzione e nel mantenimento della remissione negli adolescenti (da 15 a <18 anni di età) con malattia di Crohn attiva da moderata a grave (CD)
Protocol Addendum del sottostudio datato 08Jun2020.
Obiettivo: valutare la sicurezza e l'efficacia di miri negli adolescenti con MC.

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

- diagnosi di CD da almeno 3 mesi prima del baseline
-diagnosi di CD moderato/severo confermata e valutata tramite SF, AP score, and SES-CD
-dimostrata intolleranza, perdita di risposta o risposta inadeguata alle terapie convenzionali o biologiche per CD
-se soggetti di sesso femminile, i soggetti devono rispettare le raccomandazioni sulla contraccezione

E.4

Principal exclusion criteria

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or short bowel syndrome
• Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery.
• Have a stoma, ileoanal pouch 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

-presenza di diagnosi attuale di colite ulcerativa, IBD-U (nota come colite indeterminata), o short bowel syndrome
- stoma, una sacca ileonale o ostomia
- Attualmente ha o si sospetta che abbia un ascesso. Gli ascessi cutanei e perianali recenti non portano a esclusione se drenati, adeguatamente trattati e risolti almeno 3 settimane prima del basale o 8 settimane prima del basale per ascessi intra-addominali, a condizione che non vi sia alcuna necessità anticipata di ulteriori interventi chirurgici
-aver avuto una resezione intestinale entro 6 mesi, o qualsiasi altra chirurgia intra addominale o extra addominale entro 3 mesi dal baseline
-aver mai ricevuto una qualsiasi terapia con anticorpi monoclonali che legano 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. Percentuale di partecipanti che ottengono risposta endoscopica Risposta endoscopica basata sul punteggio endoscopico semplice per il punteggio totale della malattia di Crohn (SES-CD) [Intervallo di tempo: settimana 52]
2. Percentuale di partecipanti che raggiungono la remissione clinica La remissione clinica per paziente refertato risultato (PRO) basato sulla frequenza delle feci (SF) e dolore addominale (AP) [Time Frame: Week 52]

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 52

settimana 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. Percentuale di partecipanti che raggiungono la remissione endoscopica Remissione endoscopica basata sul punteggio totale SES-CD [Time Frame: Week 52]
4. Percentuale di partecipanti che ottengono la remissione clinica o la remissione endoscopica che erano corticosteroide Libera remissione clinica di PRO basata su SF e AP e sulla remissione endoscopica basata sul punteggio totale SES-CD [Time Frame: Week 52]
5. Percentuale di partecipanti che ottengono la remissione clinica La remissione clinica di PRO si basa su SF e AP [Time Frame: Week 12]
6. Percentuale di partecipanti che raggiungono la remissione clinica Remissione clinica basata su CDAI [Time Frame: Week 52]
7. Variazione dal valore basale nel cambiamento di proteina C-reattiva [Tempo fotogramma: linea di base, settimana 52]
8. Cambiamento rispetto al basale nella Calprotectina fecale [Time Frame: Baseline, Week 52]
9. Percentuale di partecipanti con manifestazioni extraintestinali (EIM) della malattia di Crohn
Percentuale di partecipanti con EIMs of Crohn's Disease [Time Frame: Week 52]
10. Percentuale di partecipanti con risposta alle fistole [Time Frame: Week 52]
11. Farmacocinetica (PK): area sotto la curva del tempo di concentrazione (AUC) di Mirikizumab [Time Frame: Baseline through Week 52]
12. Cambiamento rispetto al basale della qualità della vita correlata alla salute Qualità della vita correlata alla salute sulla base del punteggio del questionario sulla malattia infiammatoria delle viscere intestinali (IBDQ) [Time Frame: Baseline, Week 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

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

Information not present in EudraCT

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

Australia

Brazil

Canada

China

India

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

Taiwan

Turkey

Ukraine

United States

Austria

Belgium

Croatia

Denmark

France

Germany

Hungary

Italy

Latvia

Lithuania

Netherlands

Poland

Romania

Slovakia

Spain

Sweden

Switzerland

United Kingdom

Czechia

Argentina

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

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

1150

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).

I partecipanti che completano lo studio AMAM con la Visita 17 avranno la possibilità di proseguire con lo Studio I6T-MC-AMAX (AMAX) se idonei. I partecipanti che non soddisfano i criteri di iscrizione per lo Studio AMAX o che non scelgono di partecipare allo studio AMAX torneranno per2visite di FU post-trattamento nello studio AMAM. La1visita di controllo di questo tipo sarà4settimane dopo l'ultima dose (V801). La2visita di controllo di questo tipo sarà da12a16sett dopo l'ultima dose(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

2019-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-16

P. End of Trial
P.	End of Trial Status	Ongoing

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Orphan Designation Number:
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