Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Present with chronic plaque psoriasis based on an investigator-confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline, and meet the following criteria:: a) involving =10% body surface area (BSA) and absolute PASI score =12 in affected skin at screening (Visit 1) and baseline (Visit 2), and b) sPGA score of =3 at screening (Visit 1) and baseline (Visit 2). - Candidate for systemic therapy and/or phototherapy - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial - Are =18 years of age 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 1340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103
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. - Are women who are breastfeeding or plan to breastfeed during study - Have had serious, opportunistic or chronic/recurring infection within 3 months prior to screening - Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study. - Have any other skin conditions (excluding plaque psoriasis) that would affect interpretation of the results - Have received systemic nonbiologic therapy within 28 days prior to baseline - Have received topical treatment within 14 days prior to baseline - Have prior use of secukinumab - Have received anti-tumor necrosis factor (TNF) targeting biologics within 8 weeks prior to baseline - Have previous exposure to any biologic therapy targeting IL-12/23 (p40 subunit) or IL-23 (p19 subunit) or IL-17, either marketed or investigational.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Efficacy of mirikizumab induction dosing compared to placebo in subjects based on sPGA (0,1) and PASI 90 at Week 16;Primary end point(s): Static Physician's Global Assessment (sPGA)(0,1) and Psoriasis Area and Severity Index 90 (PASI 90) ;Secondary Objective: • Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75 at Week 4; • Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75, PASI 100, BSA =1% , PSS symptoms score of 0 in those with a PSS symptoms score =1 at baseline and and DLQI (0,1) with at least a 5-point improvement (reduction) from baseline with DLQI baseline score =5 at Week 16 • Efficacy of mirikizumab induction dosing compared to secukinumab based on sPGA (0,1) and PASI 90 at Week 16; ;Timepoint(s) of evaluation of this end point: Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 16- sPGA (0,1) PASI 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PASI 75, PASI 100, BSA =1% with psoriasis involvement, PSS, DLQI, PASI 90, sPGA (0,1);Timepoint(s) of evaluation of this end point: Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 4- PASI 75 Week 16- PASI 75, PASI 100, BSA =1% with psoriasis involvement, PSS symptoms, DLQI Timepoints to assess whether mirikizumab induction dosing is noninferior to secukinumab: Week 24- PASI 90 Week 52- sPGA (0,1), PASI 90, PASI 100 Timepoint to assess whether mirikizumab maintenance Q8W dosing is superior to secukinumab Week 52- sPGA (0,1) PASI 90 | — |
Countries
Argentina, Australia, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed