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

COMPLETEDPHASE4

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

A 24-Week Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety of Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis or Active Psoriatic Arthritis in India

NCT05855967•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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•Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.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).
+6 more criteria

Locations (14)

King George Hospital

Vizag, Andhra Pradesh, India

All India Institute of Medical Sciences

Raipur, Chhattisgarh, India

V.S. General Hospital

Ahmedabad, Gujarat, India

Amber Clinic

Ahmedabad, Gujarat, India

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, India

GMERS Medical College & Hospital

Ahmedabad, Gujarat, India

Tristar Hospital

Surat, Gujarat, India

Father Muller Medical College Hospital

Mangalore, Karnataka, India

Dr. D. Y. Patil Medical College & Hospital

Navi Mumbai, Maharashtra, India

Grant Medical Foundation - Ruby Hall Clinic

Pune, Maharashtra, India

Key Dates

Start Date

June 27, 2023

Primary Completion Date

August 8, 2024

Completion Date

September 23, 2024

Last Updated

August 22, 2025

Enrollment

250

ACTUAL participants

Conditions

Plaque PsoriasisPsoriatic Arthritis

Interventions

Ixekizumab

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab