Zusammenfassende Beschreibung der Studie (Datenquelle: 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.
Untersuchte Krankheiten(Datenquelle: BASEC)
Diese Studie untersucht Morbus Crohn (Crohn-Krankheit).
Health conditions
(Datenquelle: 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]
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: BASEC)
Diese Studie untersucht die Wirksamkeit und Sicherheit von Mirikizumab (I.V, S.C) im Vergleich zu Ustekinumab (6mg/kg I.V; 90 mg S.C) und Placebo.
Interventions
(Datenquelle: 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
Kriterien zur Teilnahme an der Studie
(Datenquelle: BASEC)
Zur Teilnahme an diesem klinischen Versuch müssen die Patienten:
- älter als 18 Jahre sein.
- seit mindestens 3 Monaten an fistulierende Crohns-Krankheit
Ausschlusskriterien
(Datenquelle: 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
(Datenquelle: WHO)
Gender:
Female: yes
Male: yes
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? no
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 55
Exclusion criteria:
? 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 intraabdominal
or extra abdominal surgery within 3 months of baseline.
? Have ever received anti-IL23p19 Antibodies.
-
Weitere Informationen zur Studie
Datum der Studienregistrierung
28.05.2019
Einschluss der ersten teilnehmenden Person
10.07.2019
Rekrutierungsstatus
Not Recruiting
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie
(Datenquelle: 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
(Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primäre Endpunkte
(Datenquelle: WHO)
Main Objective: To evaluate the efficacy of mirikizumab is superior to placebo in
participants with Crohn's disease as assessed by
- clinical response by patient reported outcome (PRO) at Week 12 and
endoscopic response at Week 52
- clinical response by patient reported outcome (PRO) at Week 12 and
clinical remission by Crohn's Disease Activity Index (CDAI) at Week 52 ;Secondary Objective: -To evaluate the efficacy of mirikizumab is superior to placebo as
assessed by endoscopic response, endoscopic remission, clinical
remission by CDAI, and Urgency NRS
- To evaluate the efficacy of mirikizumab in comparison to ustekinumab
as assessed by endoscopic response, endoscopic remission, clinical
remission by CDAI
- To evaluate the efficacy of mirikizumab in comparison to placebo in
health outcomes and quality of life measures, symptomatic endpoints,
inflammatory biomarkers
- To evaluate the pharmacokinetic and
pharmacokinetic/pharmacodynamic relationships of mirikizumab;Primary end point(s): 1. Percentage of Participants Achieving Clinical Response and
Endoscopic Response
Clinical response by Patient Reported Outcome (PRO) based on stool
frequency (SF) and abdominal pain (AP)
Endoscopic response based on Simple Endoscopic Score for Crohn's
Disease (SES-CD) total score
2. Percentage of Participants Achieving Clinical Response and Clinical
Remission
Clinical response by PRO based on SF and AP
Clinical remission based on CDAI;Timepoint(s) of evaluation of this end point: Week 12, Week 52
Sekundäre Endpunkte
(Datenquelle: WHO)
Secondary end point(s): 3. Proportion of participants achieving endoscopic response based on
Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
4. Proportion of participants achieving clinical remission by CDAI
5. Proportion of participants achieving endoscopic response based on
SES-CD total score
6. Proportion of participants achieving endoscopic remission based on
SES-CD total score
7. Percentage of Participants achieving clinical remission based on CDAI
8. Change from baseline in Urgency NRS
9. Percentage of Participants Achieving Clinical Response and Clinical
Remission based on PRO
10. Percentage of Participants Achieving Clinical Response by PRO and
Endoscopic Remission by SES-CD
11. Percentage of Participants Who Are Corticosteroid-free AND in
Clinical Response by PRO AND either in Clinical Remission by CDAI or
Endoscopic Remission by SES-CD
12. Change from Baseline in C-Reactive Protein
13. Change from Baseline in Fecal Calprotectin
14. Percentage of Participants Achieving Clinical Response by PRO with
Extraintestinal Manifestations (EIMs) of Crohn's Disease
15. Percentage of participants achieving clinical response by PRO with
fistulae response
16. Pharmacokinetics (PK): Area Under the Concentration Time Curve
(AUC) of Mirikizumab
17. Change from Baseline in Health Related Quality of Life based on
Inflammatory Bowel Disease Questionnaire (IBDQ) score;Timepoint(s) of evaluation of this end point: secondary endpoint [3 ,4, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17]
Timepoints: Week 52
secondary endpoint [5 ,6, 7, 8, 9, 10, 11, 14, 15] Timepoints: Week 12
secondary endpoint [11] Timepoints: Week 40-52
Kontakt für Auskünfte
(Datenquelle: WHO)
Eli Lilly and Company
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
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 zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Bern, St Gallen
Durchführungsländer
(Datenquelle: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Latvia, Lithuania, Mexico, Netherlands, Poland, Republic of, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
Prof. Dr. Stephan Brand
+4171 494 10 65
stephan.brand@kssg.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz (EKOS)
Datum der Bewilligung durch die Ethikkommission
05.12.2019
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2019-01133
Secondary ID (Datenquelle: WHO)
I6T-MC-AMAM
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