A Phase 3 Trial in Moderate to Severe Plaque Psoriasis Patients

Phase 1

• Conditions: Moderate to severe plaque psoriasis; MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003299-30-FR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1793

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified