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SNCTP000003754 | EUCTR2018-004614-18 | BASEC2019-01133

Ein grossangelegter kontrollierter Klinischer Versuch für Patienten mit mittelschwerem bis schwerem aktiven Morbus Crohn um das Medikament Mirikizumab auf Wirksamkeit und Sicherheit zu bewerten.

Data source: BASEC (Imported from 22.09.2021), WHO (Imported from 18.04.2021)
Changed: 15.09.2021
Disease category: Digestive Systems diseases (non cancer)

Brief description of trial (Data source: BASEC)

Die Studie untersucht Morbus Crohn. Wir machen diese Studie, um die Wirksamkeit und Sicherheit bei Mirikizumab (Studienmedikament) zu untersuchen.

In dieser Studie erhalten die Patienten Mirikizumab, Ustekinumab oder Placebo (enthält keinen Wirkstoff) zur Behandlung von Morbus Crohn.

Die Zuteilung zu den Gruppen erfolgt zufällig, das heisst, die Studie ist randomisiert. Weder Sie selbst noch Ihre Prüfärztin/Ihr Prüfarzt weiss, welches Medikament Sie erhalten. Mirikizumab ist noch nicht in der Schweiz zugelassen.

Die Studie ist in 4 Phasen unterteilt (Screening, Behandlungsphase 1, Behandlungsphase 2 and Anschlussphase) und rund 1100 Patientinnen und Patienten teilnehmen werden, darunter 12 Patienten in der Schweiz. Die Teilnahme an der Studie wird bis zu 72 Wochen (17 Monate) dauern.

Die Patienten werden gebeten, ihr Ansprechen auf das Studienmedikament in einem elektronischen Tagebuch (eDiary), das ihnen zur Verfügung gestellt wird, festzuhalten. Die Prüfärztin/der Prüfarzt wird den Patienten Näheres dazu erklären.

Health conditions investigated (Data source: BASEC)

Diese Studie untersucht Morbus Crohn (Crohn-Krankheit).

Health conditions (Data source: WHO)

moderately to severely active Crohn’s disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Diese Studie untersucht die Wirksamkeit und Sicherheit von Mirikizumab (900 mg, I.V; 300 mg, S.C) im Vergleich zu Ustekinumab (6mg/kg I.V; 90 mg S.C) und Placebo.

Interventions (Data source: WHO)


Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIRIKIZUMAB
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Mirikizumab
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: STELARA 130 mg concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: MIRIKIZUMAB
Product

Criteria for participation in trial (Data source: BASEC)

Zur Teilnahme an diesem klinischen Versuch müssen die Patienten:

- älter als 18 Jahre sein.
- seit mindestens 3 Monaten an fistulierende Crohns-Krankheit

Exclusion criteria (Data source: BASEC)

Eine Teilnahme ist nicht möglich wenn die Patienten:
- schwanger sind oder noch stillen
- an Krebs leiden
- an Colitis ulcerosa, Kurzdarmsyndrom oder Reizdarmsyndrom leiden.

Inclusion/Exclusion Criteria (Data source: WHO)

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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 55

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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004614-18

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2018-004614-18-PL

Further information on trial

Date trial registered

09.07.2019

Incorporation of the first participant

03.09.2019

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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 - VIVID-1

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: Ustekinumab
Number of treatment arms in the trial: 3

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: To evaluate the clinical efficacy of mirikizumab in participants with Crohn's disease.
;Secondary Objective: - 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.
;Timepoint(s) of evaluation of this end point: Week 52;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]

Secundary end point (Data source: WHO)

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

;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]

Contact information (Data source: WHO)

Eli Lilly and Company

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bern, St. Gallen

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Republic of, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. Stephan Brand
+4171 494 10 65
stephan.brand@kssg.ch

Contact for general information (Data source: WHO)

Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com

Contact for scientific information (Data source: WHO)

Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Eli Lilly and Company

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Ostschweiz (EKOS)

Date of authorisation by the ethics committee

05.12.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01133

Secondary ID (Data source: WHO)

I6T-MC-AMAM
2018-004614-18-HU