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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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05855967
Collaborator
(none)
250
Enrollment
15
Locations
1
Arm
14.5
Anticipated Duration (Months)
16.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jul 5, 2023
Anticipated Primary Completion Date :
Jul 17, 2024
Anticipated Study Completion Date :
Sep 19, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75) [Week 12]

    2. Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1) [Week 12]

    3. Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20) [Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 All India Institute of Medical Sciences Raipur Chhattisgarh India 492099
    2 V.S. General Hospital Ahmedabad Gujarat India 380006
    3 Amber Clinic Ahmedabad Gujarat India 380015
    4 B. J. Medical College & Civil Hospital Ahmedabad Gujarat India 380016
    5 GMERS Medical College & Civil Hospital Ahmedabad Gujarat India 380060
    6 Tristar Hospital Surat Gujarat India 395001
    7 Father Muller Medical College Hospital Mangalore Karnataka India 575002
    8 Lilavati Hospital And Research Centre Mumbai Maharashtra India 400050
    9 Government Medical College And Hospital - Nagpur Nagpur Maharashtra India 440003
    10 Dr. D. Y. Patil Medical College & Hospital Navi Mumbai Maharashtra India 400706
    11 Center for Rheumatic Diseases Pune Maharashtra India 411001
    12 Grant Medical Foundation - Ruby Hall Clinic Pune Maharashtra India 411001
    13 Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh Punjab India 160012
    14 Wizderm Specialty Skin & Hair Clinic Kolkata West Bengal India 700017
    15 Medical College & Hospital Kolkata West Bengal India 700073

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05855967
    Other Study ID Numbers:
    • 18528
    • I1F-IN-RHCZ
    First Posted:
    May 12, 2023
    Last Update Posted:
    May 12, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic
    Psoriasis
    Ixekizumab

    Study Results

    No Results Posted as of May 12, 2023