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

Last updated: August 6, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

4

Condition

Warts

Arthritis And Arthritic Pain

Psoriatic Arthritis

Treatment

Ixekizumab

Clinical Study ID

NCT05855967
18528
I1F-IN-RHCZ
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 forat 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 PsoriasisArea 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 medicalhistory 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 ahistory 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 3/66swollen joints, as determined by the Tender and Swollen Joint Count Assessment Format screening and baseline.

  • Presence of active PsO or a documented history of psoriasis.

Exclusion

Exclusion Criteria:

  • Have previously completed or withdrawn from this study, participated in any otherstudy with ixekizumab, or have participated in any study investigating other IL-17antagonists.

  • Have a history of drug-induced PsO.

  • Have a known allergy or hypersensitivity to any biologic therapy that would pose anunacceptable risk to the patient if participating in this study.

  • Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or willrequire such during the study that, in the opinion of the investigator inconsultation with Lilly or its designee, would pose an unacceptable risk to theparticipant

  • 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 8weeks 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 forPsA or PsO, including investigational therapies (such as, but not limited to, atumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor,anti-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab.

  • Have had surgical treatment of a joint within 8 weeks prior to baseline or willrequire such up to Week 24.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Ixekizumab
Phase: 4
Study Start date:
June 27, 2023
Estimated Completion Date:
September 23, 2024

Connect with a study center

  • King George Hospital

    Vizag, Andhra Pradesh 530002
    India

    Site Not Available

  • King George Hospital

    Vizag 1253102, Andhra Pradesh 1278629 530002
    India

    Site Not Available

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh 492099
    India

    Site Not Available

  • All India Institute of Medical Sciences

    Raipur 1258980, Chhattisgarh 1444364 492099
    India

    Site Not Available

  • Amber Clinic

    Ahmedabad, Gujarat 380015
    India

    Site Not Available

  • B. J. Medical College & Civil Hospital

    Ahmedabad, Gujarat 380016
    India

    Site Not Available

  • GMERS Medical College & Civil Hospital

    Ahmedabad, Gujarat 380060
    India

    Site Not Available

  • GMERS Medical College & Hospital

    Ahmedabad, Gujarat 380060
    India

    Site Not Available

  • V.S. General Hospital

    Ahmedabad, Gujarat 380006
    India

    Site Not Available

  • Tristar Hospital

    Surat, Gujarat 395001
    India

    Site Not Available

  • Amber Clinic

    Ahmedabad 1279233, Gujarat 1270770 380015
    India

    Site Not Available

  • B. J. Medical College & Civil Hospital

    Ahmedabad 1279233, Gujarat 1270770 380016
    India

    Site Not Available

  • GMERS Medical College & Hospital

    Ahmedabad 1279233, Gujarat 1270770 380060
    India

    Site Not Available

  • V.S. General Hospital

    Ahmedabad 1279233, Gujarat 1270770 380006
    India

    Site Not Available

  • Tristar Hospital

    Surat 1255364, Gujarat 1270770 395001
    India

    Site Not Available

  • Father Muller Medical College Hospital

    Mangalore, Karnataka 575002
    India

    Site Not Available

  • Father Muller Medical College Hospital

    Mangalore 1263780, Karnataka 1267701 575002
    India

    Site Not Available

  • Lilavati Hospital And Research Centre

    Mumbai, Maharashtra 400050
    India

    Site Not Available

  • Government Medical College And Hospital - Nagpur

    Nagpur, Maharashtra 440003
    India

    Site Not Available

  • Dr. D. Y. Patil Medical College & Hospital

    Navi Mumbai, Maharashtra 400706
    India

    Site Not Available

  • Center for Rheumatic Diseases

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra 411001
    India

    Site Not Available

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

    Pune, Maharashtra 411005
    India

    Site Not Available

  • Dr. D. Y. Patil Medical College & Hospital

    Navi Mumbai 6619347, Maharashtra 1264418 400706
    India

    Site Not Available

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune 1259229, Maharashtra 1264418 411001
    India

    Site Not Available

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

    Pune 1259229, Maharashtra 1264418 411005
    India

    Site Not Available

  • Post Graduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, Punjab 160012
    India

    Site Not Available

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, Punjab 1259223 160012
    India

    Site Not Available

  • Medical College & Hospital

    Kolkata, West Bengal 700073
    India

    Site Not Available

  • Wizderm Specialty Skin And Hair Clinic

    Kolkata, West Bengal 700017
    India

    Site Not Available

  • Medical College & Hospital

    Kolkata 1275004, West Bengal 1252881 700073
    India

    Site Not Available

  • Wizderm Specialty Skin And Hair Clinic

    Kolkata 1275004, West Bengal 1252881 700017
    India

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.