A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

Lilly

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02899988

2016-001098-34 (EudraCT Number)

I6T-MC-AMAF (Other Identifier)

16481

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.

Enrollment: 205 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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:

  • plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
  • sPGA score of ≥3 at screening and baseline

• Candidate for biologic treatment for psoriasis.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 4 patient groups, including a placebo group

30 mg Mirikizumab

Experimental group

Description:

30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).

Treatment:

Drug: Mirikizumab

100 mg Mirikizumab

Experimental group

Description:

100 mg Mirikizumab administered SC Q8W.

Treatment:

Drug: Mirikizumab

300 mg Mirikizumab

Experimental group

Description:

300 mg Mirikizumab administered SC Q8W.

Treatment:

Drug: Mirikizumab

Placebo

Placebo Comparator group

Description:

Placebo administered SC Q8W.

Treatment:

Drug: Placebo