Phase 4
N=250
A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
Plaque Psoriasis · Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT05855967 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Aug 2025
Primary outcome: Primary: 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 — 1; 0; 60; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ixekizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1; 0; 60; 8; 39; 6 | — |
| SECONDARY PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 |
86.0 | — |
| SECONDARY PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) |
65.3 | — |
| SECONDARY Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 |
84.0 | — |
Summary
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)
Eligibility Criteria
Inclusion Criteria
All participants:
- Male or nonpregnant, nonbreastfeeding female participants.
For PsO Participants:
- Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline
- Have ≥10% Body Surface Area (BSA) of psoriasis at screening (Visit 1) and baseline
- Have both an static Physician's Global Assessment (sPGA) score of ≥3 and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline
For PsA Participants
- Have a diagnosis of active PsA for at least 6 months (based on a detailed medical history provided by the patient, and a physical exam by the Study Investigator, and/or other evidence such as that provided by joint x-rays, that establishes a history consistent with a diagnosis of active PsA of at least 6 months' duration) and currently meet the Classification for PsA (CASPAR) criteria.
- Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints, as determined by the Tender and Swollen Joint Count Assessment Form at screening and baseline.
- Presence of active PsO or a documented history of psoriasis.
Exclusion Criteria
- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.
- Have a history of drug-induced PsO.
- Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
- Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or will require such during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
- Have diagnosis or history of malignant disease within the 5 years prior to baseline
- Have any other active or recent infection within 4 weeks of baseline
For PsO Participants:
- Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)
- Have pustular, erythrodermic, and/or guttate forms of PsO
- Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).
- Have allergy to rubber or latex.
For PsA Participants:
- Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than methotrexate (MTX), leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline
- Have received treatment with interleukin (IL)17 or IL-12/23 targeted Mab therapy
- Are currently receiving treatment with any biologic or small molecule therapy for PsA or PsO, including investigational therapies (such as, but not limited to, a tumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor, anti-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4 inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab.
- Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.
Data sourced from ClinicalTrials.gov (NCT05855967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.