A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque o… (NCT05855967) | Clinical Trial Compass
CompletedPhase 4
A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
India250 participantsStarted 2023-06-27
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.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 …
What they're measuring
1
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