A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Sponsor
Eli Lilly and Company
Study ID
NCT05855967
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)

Key Dates

Start date
Jun 27, 2023
Status verified
Aug 2025
Primary completion
Aug 8, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
250 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab - PsO With no Active PsA
    Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received: * Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20
  • Experimental: Ixekizumab - Active PsA
    Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20 Participants with active PsA without moderate to severe PsO received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by * Ixekizumab 80 mg SC injection Q4W at Week 4, 8, 12, 16, and 20.

Primary Outcome Measure

Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 [ Time Frame: Week 0 to Week 24 ]

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