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: Active, not recruiting
• Conditions: Plaque Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Drug: Ixekizumab

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

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• India
  • Andhra Pradesh
    • Vizag, Andhra Pradesh, India, 530002
      • King George Hospital
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492099
      • All India Institute of Medical Sciences
      • Contact: Phone Number: 7639471456
      • Principal Investigator: Satyaki Ganguly
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Amber Clinic
      • Principal Investigator: Vishnu Devkinandan Sharma
    • Ahmedabad, Gujarat, India, 380006
      • V.S. General Hospital
      • Contact: Phone Number: 8980024107
      • Principal Investigator: Dhaiwat Shukla
    • Ahmedabad, Gujarat, India, 380016
      • B. J. Medical College & Civil Hospital
      • Contact: Phone Number: 9898059289
      • Principal Investigator: Bela shah
    • Ahmedabad, Gujarat, India, 380060
      • GMERS Medical College & Hospital
    • Surat, Gujarat, India, 395001
      • Tristar Hospital
      • Contact: Phone Number: 8238004052
      • Principal Investigator: Romi Shah
  • Karnataka
    • Mangalore, Karnataka, India, 575002
      • Father Muller Medical College Hospital
      • Principal Investigator: Ramesh Bhat
      • Contact: Phone Number: 9845084224
  • Maharashtra
    • Navi Mumbai, Maharashtra, India, 400706
      • Dr. D. Y. Patil Medical College & Hospital
      • Contact: Phone Number: 9322266687
      • Principal Investigator: Godse Kiran Vasant
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation - Ruby Hall Clinic
      • Principal Investigator: Ajit Nalawade
      • Contact: Phone Number: 9822746248
    • Pune, Maharashtra, India, 411005
      • Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
      • Contact: Phone Number: 9422087726
      • Principal Investigator: Hemantkumar Vasantrao Talnikar
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Postgraduate Institute of Medical Education & Research
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Medical College & Hospital
      • Contact: Phone Number: 9038831211
      • Principal Investigator: Kaushik Basu
    • Kolkata, West Bengal, India, 700017
      • Wizderm Specialty Skin And Hair Clinic
      • Contact: Phone Number: 9903275551
      • Principal Investigator: Abhishek De

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 sPGA score of ≥3 and 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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ixekizumab; Participants with moderate to severe plaque psoriasis. Participants with active psoriatic arthritis. Ixekizumab will be given by subcutaneous (SC) injection.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Plaque Psoriasis and with Psoriatic Arthritis Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs)	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75)	Week 12
Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1)	Week 12
Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20)	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 (Estimated): July 17, 2024
• Study Completion (Estimated): September 20, 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 (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; 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