Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Mirikizumab (LY3074828)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Mirikizumab
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZ
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have completed the last visit of an eligible study period of 1 of the originator studies (Study AMAF, AMAJ, AMAK, or AMBK). - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial -Have given written informed consent as a legal adult according to local regulations 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 1664 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 129
Exclusion criteria
Exclusion criteria: - Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal,endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety within the study or of interfering with the interpretation of data. - Have a known hypersensitivity to mirikizumab or any component of this investigational product. - Have had investigational product permanently discontinued during a previous mirikizumab study. - Have had temporary investigational product interruption at any time during or at the final study visit of a previous mirikizumab study and, in the opinion of the investigator, restarting mirikizumab would pose an unacceptable risk for the patient’s participation in the study. - Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To access long-term maintenance of efficacy of mirikizumab in subjects based upon sPGA (0, 1) and =90% improvement in PASI 90 among those who entered Study AMAH with sPGA (0,1) and PASI 90 response.;Secondary Objective: To access long term efficacy and patient reported outcomes with mirikizumab treatment in subjects based upon sPGA (0,1), PASI 90, PASI 100, PSS symptoms score of 0 in those with a PSS symptoms score =1 at baseline, (DLQI) score of 0,1 with baseline score >1 and % change in (PPASI), (PSSI) and (NAPSI).;Primary end point(s): Static Physician's Global Assessment (sPGA)(0,1) and Psoriasis Area and Severity Index 90 (PASI 90);Timepoint(s) of evaluation of this end point: Over the course of the study •Proportion of patients with an sPGA (0,1) and =90% improvement in PASI (PASI 90) among those who entered Study AMAH with sPGA (0,1) and PASI 90 response | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): sPGA (0,1), PASI 90, PASI 100, PSS symptoms score, DLQI, PPASI, PSSI and NAPSI;Timepoint(s) of evaluation of this end point: Over the course of the study •Proportion of patients achieving sPGA (0,1), PASI 90, PASI 100 •Proportion of patients achieving PSS symptom score of 0 & in those with a PSS symptoms score =1 at baseline and (DLQI) score of 0,1 with baseline score >1 •Percent change in total score of PPASI, PSSI and NAPSI in those with palmoplantar involvement, scalp involvement and fingernail involvement at baseline | — |
Countries
Argentina, Australia, Canada, Czechia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed