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

NCT05855967 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 18528I1F-IN-RHCZ
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 14

Brief 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)

Conditions

Plaque Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (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

  * 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 Outcomes (3)

• 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

  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)

  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

  Week 24

Study Arms (2)

Ixekizumab - PsO With no Active PsA

EXPERIMENTAL

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

Ixekizumab - Active PsA

EXPERIMENTAL

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

Interventions

Ixekizumab DRUG

Administered SC

Also known as: LY2439821

Ixekizumab - Active PsA; Ixekizumab - PsO With no Active PsA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

King George Hospital

Vizag, Andhra Pradesh, 530002, India

Location

All India Institute of Medical Sciences

Raipur, Chhattisgarh, 492099, India

Location

V.S. General Hospital

Ahmedabad, Gujarat, 380006, India

Location

Amber Clinic

Ahmedabad, Gujarat, 380015, India

Location

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

GMERS Medical College & Hospital

Ahmedabad, Gujarat, 380060, India

Location

Tristar Hospital

Surat, Gujarat, 395001, India

Location

Father Muller Medical College Hospital

Mangalore, Karnataka, 575002, India

Location

Dr. D. Y. Patil Medical College & Hospital

Navi Mumbai, Maharashtra, 400706, India

Location

Grant Medical Foundation - Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)

Pune, Maharashtra, 411005, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Wizderm Specialty Skin And Hair Clinic

Kolkata, West Bengal, 700017, India

Location

Medical College & Hospital

Kolkata, West Bengal, 700073, India

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: June 27, 2023
• Primary Completion: August 8, 2024
• Study Completion: September 23, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IN (14)