A multicenter, open-label phase 3 long-term extension study to evaluate the long-term efficacy and safety of Mirikizumab in patients with Crohn's disease.
Zusammenfassung der Studie
The main purpose of your participation in the study is less about the treatment of your condition, but rather to answer the following scientific questions: • Whether Mirikizumab (LY3074828) can help patients with Crohn's disease with prolonged use. • How safe Mirikizumab is and what side effects it has with long-term administration. If you decide to participate, you will be treated with Mirikizumab. The medication will be administered as an injection under the skin. Duration: You may participate in this study for a period of up to 3 years. You can withdraw from the study at any time. The follow-up phase after treatment lasts 12 to 16 weeks after the last dose of the study medication. There will be 19 examination visits during the study (in person or by phone) and 2 follow-up visits after the last dose of the study medication.
(BASEC)
Untersuchte Intervention
If you decide to participate, you will be treated with Mirikizumab.
If you are willing to participate in the study, you will receive Mirikizumab once every 4 weeks. All participants in the AMAG study will receive Mirikizumab as an injection under the skin. Participants in the AMAM study whose endoscopy results do not show the required improvement will receive their first 3 doses as intravenous (IV) injection as part of this study. Following the first 3 doses, participants in this group who show improvement will receive the subsequent doses as injections under the skin. All other participants in the AMAM study whose endoscopy results show the required improvement will receive all doses of Mirikizumab as injections under the skin.
(BASEC)
Untersuchte Krankheit(en)
This study investigates Crohn's disease.
(BASEC)
(1) Participants from the phase III AMAM study (EudraCT 2018-004614-18), for whom the following applies: Participants who have completed all study assessments at week 52 of the AMAM study, including the endoscopy at week 52 to assess responder/non-responder status, and who, in the opinion of the investigator, would derive clinical benefit from treatment with Mirikizumab. (BASEC)
Ausschlusskriterien
(1) Participants who have been diagnosed with any disease (or signs or symptoms of a disease), including the development of a malignant disease or suspicion of an active malignant disease prior to dose administration at visit 1 of the AMAX study, which would have excluded them from the previous originator study or necessitated withdrawal from the study. (2) [14] Participants who have been diagnosed with a serious infection (including but not limited to hepatitis B, hepatitis C, HIV, and active tuberculosis [TB]) during the originator study or prior to dose administration at visit 1 of the AMAX study. (3) Participants with a known hypersensitivity to any component of this investigational product or monoclonal antibodies, or participants who have experienced an acute systemic hypersensitivity reaction upon previous administration of the investigational product, thereby excluding Mirikizumab therapy. (BASEC)
Studienstandort
Bern, St Gallen
(BASEC)
Sponsor
Sponsor: Eli Lilly and Company Sponsor Representative: Eli Lilly (Suisse) SA
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. Stephan Brand
+4171 494 10 65
stephan.brand@clutterkssg.chKantonsspital St. Gallen
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.06.2022
(BASEC)
ICTRP Studien-ID
EUCTR2019-002687-27 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease -VIVID 2 (BASEC)
Wissenschaftlicher Titel
A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 (ICTRP)
Öffentlicher Titel
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (ICTRP)
Untersuchte Krankheit(en)
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] (ICTRP)
Untersuchte Intervention
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-
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-
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-
(ICTRP)
Studientyp
Interventional clinical trial of medicinal product (ICTRP)
Studiendesign
Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2 (ICTRP)
Ein-/Ausschlusskriterien
Gender:
Female: yes
Male: yes
Inclusion criteria:
1. Participants who have completed the Phase 2 Study I6T-MC-AMAG (EudraCT 2016- 002204-84), and in the opinion of the investigator, would derive clinical benefit from continued treatment with mirikizumab
2. Participants who have completed the Phase 3 Study I6T-MC-AMAM (2018-004614-18) and in the opinion of the investigator would derive clinical benefit from treatment with mirikizumab
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 708
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
(ICTRP)
Exclusion criteria:
-Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
-Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study
-Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study
-Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
Primäre und sekundäre Endpunkte
Main Objective: To evaluate the long-term efficacy of mirikizumab;Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes
;Primary end point(s): Proportion of participants achieving endoscopic response. Endoscopic response is based on SES-CD score.;Timepoint(s) of evaluation of this end point: Week 52 (ICTRP)
Secondary end point(s): -Proportion of participants achieving clinical remission. Clinical remission is based on the Patient Reported Outcome (PRO) of stool frequency (SF) and abdominal pain (AP).
-Proportion of participants achieving endoscopic remission. Endoscopic remission is based on SES-CD score.
-IBDQ scores over time.
;Timepoint(s) of evaluation of this end point: Weeks 52, 156 (ICTRP)
Registrierungsdatum
11.03.2021 (ICTRP)
Einschluss des ersten Teilnehmers
17.06.2021 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Clinical Trial Registry Office, EU_Lilly_Clinical_Trials@lilly.com, Eli Lilly (ICTRP)
Sekundäre IDs
I6T-MC-AMAX, NCT04232553, 2019-002687-27-HU (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002687-27 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar