Phase
Condition
Warts
Arthritis And Arthritic Pain
Psoriatic Arthritis
Treatment
Ixekizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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Have previously completed or withdrawn from this study, participated in any otherstudy with ixekizumab, or have participated in any study investigating other IL-17antagonists.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
Connect with a study center
King George Hospital
Vizag, Andhra Pradesh 530002
IndiaSite Not Available
King George Hospital
Vizag 1253102, Andhra Pradesh 1278629 530002
IndiaSite Not Available
All India Institute of Medical Sciences
Raipur, Chhattisgarh 492099
IndiaSite Not Available
All India Institute of Medical Sciences
Raipur 1258980, Chhattisgarh 1444364 492099
IndiaSite Not Available
Amber Clinic
Ahmedabad, Gujarat 380015
IndiaSite Not Available
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat 380016
IndiaSite Not Available
GMERS Medical College & Civil Hospital
Ahmedabad, Gujarat 380060
IndiaSite Not Available
GMERS Medical College & Hospital
Ahmedabad, Gujarat 380060
IndiaSite Not Available
V.S. General Hospital
Ahmedabad, Gujarat 380006
IndiaSite Not Available
Tristar Hospital
Surat, Gujarat 395001
IndiaSite Not Available
Amber Clinic
Ahmedabad 1279233, Gujarat 1270770 380015
IndiaSite Not Available
B. J. Medical College & Civil Hospital
Ahmedabad 1279233, Gujarat 1270770 380016
IndiaSite Not Available
GMERS Medical College & Hospital
Ahmedabad 1279233, Gujarat 1270770 380060
IndiaSite Not Available
V.S. General Hospital
Ahmedabad 1279233, Gujarat 1270770 380006
IndiaSite Not Available
Tristar Hospital
Surat 1255364, Gujarat 1270770 395001
IndiaSite Not Available
Father Muller Medical College Hospital
Mangalore, Karnataka 575002
IndiaSite Not Available
Father Muller Medical College Hospital
Mangalore 1263780, Karnataka 1267701 575002
IndiaSite Not Available
Lilavati Hospital And Research Centre
Mumbai, Maharashtra 400050
IndiaSite Not Available
Government Medical College And Hospital - Nagpur
Nagpur, Maharashtra 440003
IndiaSite Not Available
Dr. D. Y. Patil Medical College & Hospital
Navi Mumbai, Maharashtra 400706
IndiaSite Not Available
Center for Rheumatic Diseases
Pune, Maharashtra 411001
IndiaSite Not Available
Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra 411001
IndiaSite Not Available
Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
Pune, Maharashtra 411005
IndiaSite Not Available
Dr. D. Y. Patil Medical College & Hospital
Navi Mumbai 6619347, Maharashtra 1264418 400706
IndiaSite Not Available
Grant Medical Foundation - Ruby Hall Clinic
Pune 1259229, Maharashtra 1264418 411001
IndiaSite Not Available
Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
Pune 1259229, Maharashtra 1264418 411005
IndiaSite Not Available
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Punjab 160012
IndiaSite Not Available
Postgraduate Institute of Medical Education & Research
Chandigarh, Punjab 1259223 160012
IndiaSite Not Available
Medical College & Hospital
Kolkata, West Bengal 700073
IndiaSite Not Available
Wizderm Specialty Skin And Hair Clinic
Kolkata, West Bengal 700017
IndiaSite Not Available
Medical College & Hospital
Kolkata 1275004, West Bengal 1252881 700073
IndiaSite Not Available
Wizderm Specialty Skin And Hair Clinic
Kolkata 1275004, West Bengal 1252881 700017
IndiaSite Not Available

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