A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03482011

I6T-MC-AMAK (Other Identifier)

2017-003298-32 (EudraCT Number)

16505

Details and patient eligibility

About

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

Enrollment: 530 patients

Sex: All

Ages: 18+ 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% BSA and absolute PASI score ≥12 in affected skin at screening and baseline
  • sPGA score of ≥3 at screening and baseline

• Candidate for systemic therapy and/or phototherapy for psoriasis.

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 participant safety within the study or of interfering with the interpretation of data.
• Breastfeeding or nursing women.
• 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 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 12 weeks prior to baseline.
• Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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530 participants in 2 patient groups, including a placebo group

Mirikizumab

Experimental group

Description:

Induction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (\<PASI 90).

Treatment:

Drug: Mirikizumab

Placebo

Placebo Comparator group

Description:

Induction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (\< PASI 90).

Treatment:

Drug: Placebo