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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05855967
Other study ID # 18528
Secondary ID I1F-IN-RHCZ
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date June 27, 2023
Est. completion date September 20, 2024

Study information

Verified date February 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date September 20, 2024
Est. primary completion date July 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion Criteria: - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.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 Design


Intervention

Drug:
Ixekizumab
Administered SC

Locations

Country Name City State
India Amber Clinic Ahmedabad Gujarat
India B. J. Medical College & Civil Hospital Ahmedabad Gujarat
India GMERS Medical College & Hospital Ahmedabad Gujarat
India V.S. General Hospital Ahmedabad Gujarat
India Postgraduate Institute of Medical Education & Research Chandigarh Punjab
India Medical College & Hospital Kolkata West Bengal
India Wizderm Specialty Skin And Hair Clinic Kolkata West Bengal
India Father Muller Medical College Hospital Mangalore Karnataka
India Dr. D. Y. Patil Medical College & Hospital Navi Mumbai Maharashtra
India Grant Medical Foundation - Ruby Hall Clinic Pune Maharashtra
India Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.) Pune Maharashtra
India All India Institute of Medical Sciences Raipur Chhattisgarh
India Tristar Hospital Surat Gujarat
India King George Hospital Vizag Andhra Pradesh

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75) Week 12
Secondary Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1) Week 12
Secondary Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20) Week 24
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