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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

Primary Purpose

Plaque Psoriasis, Psoriatic Arthritis

Status
Recruiting
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Ixekizumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Exclusion Criteria: Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.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

Sites / Locations

  • All India Institute of Medical Sciences
  • V.S. General HospitalRecruiting
  • Amber ClinicRecruiting
  • B. J. Medical College & Civil HospitalRecruiting
  • GMERS Medical College & Civil Hospital
  • Tristar HospitalRecruiting
  • Father Muller Medical College HospitalRecruiting
  • Government Medical College And Hospital - Nagpur
  • Dr. D. Y. Patil Medical College & Hospital
  • Center for Rheumatic Diseases
  • Grant Medical Foundation - Ruby Hall ClinicRecruiting
  • Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)Recruiting
  • Postgraduate Institute of Medical Education & Research
  • Wizderm Specialty Skin And Hair ClinicRecruiting
  • Medical College & Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ixekizumab

Arm Description

Participants with moderate to severe plaque psoriasis. Participants with active psoriatic arthritis. Ixekizumab will be given by subcutaneous (SC) injection.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75)
Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1)
Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20)

Full Information

First Posted
May 4, 2023
Last Updated
October 1, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05855967
Brief Title
A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
July 17, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis, Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ixekizumab
Arm Type
Experimental
Arm Description
Participants with moderate to severe plaque psoriasis. Participants with active psoriatic arthritis. Ixekizumab will be given by subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
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)
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75)
Time Frame
Week 12
Title
Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1)
Time Frame
Week 12
Title
Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
Raipur
State/Province
Chhattisgarh
ZIP/Postal Code
492099
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
7639471456
First Name & Middle Initial & Last Name & Degree
Satyaki Ganguly
Facility Name
V.S. General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
8980024107
First Name & Middle Initial & Last Name & Degree
Dhaiwat Shukla
Facility Name
Amber Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishnu Devkinandan Sharma
Facility Name
B. J. Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9898059289
First Name & Middle Initial & Last Name & Degree
Bela shah
Facility Name
GMERS Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9227222221
First Name & Middle Initial & Last Name & Degree
Krina Patel
Facility Name
Tristar Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395001
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
8238004052
First Name & Middle Initial & Last Name & Degree
Romi Shah
Facility Name
Father Muller Medical College Hospital
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9845084224
First Name & Middle Initial & Last Name & Degree
Ramesh Bhat
Facility Name
Government Medical College And Hospital - Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9665037576
First Name & Middle Initial & Last Name & Degree
Jayesh Mukhi
Facility Name
Dr. D. Y. Patil Medical College & Hospital
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9322266687
First Name & Middle Initial & Last Name & Degree
Godse Kiran Vasant
Facility Name
Center for Rheumatic Diseases
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9822039297
First Name & Middle Initial & Last Name & Degree
Arvind Chopra
Facility Name
Grant Medical Foundation - Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9822746248
First Name & Middle Initial & Last Name & Degree
Ajit Nalawade
Facility Name
Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9422087726
First Name & Middle Initial & Last Name & Degree
Hemantkumar Vasantrao Talnikar
Facility Name
Postgraduate Institute of Medical Education & Research
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9815924777
First Name & Middle Initial & Last Name & Degree
Sanjeev Handa
Facility Name
Wizderm Specialty Skin And Hair Clinic
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700017
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9903275551
First Name & Middle Initial & Last Name & Degree
Abhishek De
Facility Name
Medical College & Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9038831211
First Name & Middle Initial & Last Name & Degree
Kaushik Basu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/

Learn more about this trial

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

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