I6T-MC-AMAF

Phase 2

Completed

• Conditions: Psoriasis

• Registration Number: JPRN-jRCT2080223452
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-31
• Study Completion: 2019-10-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Present with chronic plaque psoriasis for at least 6 months prior to baseline and meet the following criteria: plaque psoriasis involving 10% BSA or more, PASI score 12 or more, sPGA score of 3 or more.

Exclusion Criteria

-Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
-Breastfeeding or nursing (lactating) women.
-Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
-Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study.
-Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
-Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
-Have received topical psoriasis treatment within 14 days prior to baseline.
-Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline.

-Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

Study & Design

• Study Type: Interventional
• Study Design: Not specified