A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Secukinumab; Drug: Mirikizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03535194

I6T-MC-AMAJ (Other Identifier)

16504

2017-003286-10 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

Enrollment: 1,484 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have chronic plaque psoriasis for at least 6 months.

Exclusion criteria

• Participant must not be breastfeeding or nursing woman.
• Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
• Participant must not 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.
• Participant must not have any other skin conditions (excluding psoriasis).
• Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
• Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
• Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,484 participants in 5 patient groups

250mg Q4W/250mg Q8W Mirikizumab

Experimental group

Description:

Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

Treatment:

Drug: Mirikizumab

250mg Q4W/125mg Q8W Mirikizumab

Experimental group

Description:

Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

Treatment:

Drug: Mirikizumab

Placebo/250mg Mirikizumab

Experimental group

Description:

Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.

Treatment:

Drug: Mirikizumab

Drug: Placebo

300mg Secukinumab

Active Comparator group

Description:

Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.

Treatment:

Drug: Secukinumab

Japan GPP/EP

Experimental group

Description:

Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.

Treatment:

Drug: Mirikizumab