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

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)

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Drug: Ixekizumab

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Vizag, Andhra Pradesh, India, 530002
      • King George Hospital
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492099
      • All India Institute of Medical Sciences
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Amber Clinic
    • Ahmedabad, Gujarat, India, 380006
      • V.S. General Hospital
    • Ahmedabad, Gujarat, India, 380016
      • B. J. Medical College & Civil Hospital
    • Ahmedabad, Gujarat, India, 380060
      • GMERS Medical College & Hospital
    • Surat, Gujarat, India, 395001
      • Tristar Hospital
  • Karnataka
    • Mangalore, Karnataka, India, 575002
      • Father Muller Medical College Hospital
  • Maharashtra
    • Navi Mumbai, Maharashtra, India, 400706
      • Dr. D. Y. Patil Medical College & Hospital
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation - Ruby Hall Clinic
    • Pune, Maharashtra, India, 411005
      • Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Postgraduate Institute of Medical Education & Research
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Medical College & Hospital
    • Kolkata, West Bengal, India, 700017
      • Wizderm Specialty Skin And Hair Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
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.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect.; TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period.	Week 0 to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.	Week 12
PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal)	The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here.	Week 12
Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24	The ACR 20 is defined as: 20% improvement from baseline in both tender joint count (68 counts) and swollen joint count (66 counts); 20% improvements improvement in at least three of the following five items: Patient's global assessment of arthritis pain (measured on a 100-mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100-mm VAS); Physician's global assessment of disease activity (measured on a 100-mm VAS); Patient's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI); Acute-phase reactant as measured by high-sensitivity C-reactive protein (hs-CRP) assay.	Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic; Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 18528; I1F-IN-RHCZ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes