Health Condition 1: M049- Autoinflammatory syndrome, unspecified Health Condition 2: null- Patients with Psoriatic Arthritis
Conditions
Interventions
Intervention1: Ixekizumab: Ixekizumab - 80 mg subcutaneous (SC)injection: A starting dose of ixekizumab 160 mg (two 80-mg SC injections) will be administered at randomization (Visit 2
[Week 0]) for al
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1] Are male or female patients 18 years or older [1a] Male patients agree to use a reliable method of birth control during the study. [1b] Female patients: Are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after the last dose of investigational product, whichever is longer. Methods of contraception considered acceptable when used properly include oral contraceptives, contraceptive patch, injectable or implantable contraceptives, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive foam. OR Are women of non childbearing potential, defined as: Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation); OR Women who are >=60 years of age; OR Women >=40 and >=12 months and a FSH test confirming non-childbearing potential (>=40 mIU/mL). [2] Have a documented diagnosis of PsA for at least 6 months and currently meet the CASPAR classification criteria. [3] Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints at Visit 1 (Screening) and Visit 2 (Week0). [4] Have active psoriatic skin lesions (plaque psoriasis) with a BSA >=3% at Visit 1 (Screening) and Visit 2 (Week 0).
Exclusion criteria
Exclusion criteria: 1. Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study 2. Have received any prior, or are currently receiving, treatment with any bDMARD therapy or small-molecule for PsA or for psoriasis, including investigational therapies (such as but not limited to TNF inhibitors, IL-1 receptor antagonists, IL-6 inhibitors, anti-IL-12/23p40 therapies, T cell or B cell targeted therapies, or Janus kinase inhibitors). 3. Have previously completed or withdrawn from this study or any other study investigating ixekizumab or other IL-17 inhibitors, eg, anti-IL-17 or anti-IL-17 receptor (anti-IL-17R) monoclonal antibodies. 4. Have a history of drug-induced Ps 5. Have used csDMARDs other than MTX,leflunomide, sulfasalazine, or cyclosporine or hydroxychloroquine in the 8 weeks prior to randomization (Visit 2). 6. Have discontinued MTX, sulfasalazine, hydroxychloroquine, or cyclosporine within 12 weeks prior to randomization. 7. Have discontinued leflunomide within 4 weeks prior to randomization or have received leflunomide from 4 to 12 weeks prior to randomization and have not undergone a drug elimination procedure. 8. Use of oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent, or use of variable doses of any oral corticosteroids, within 4 weeks prior to randomization (Visit 2). 9. Have received any parenteral glucocorticoid administered by intraarticular, intramuscular, or intravenous (IV) injection within 6 weeks prior to randomization, or for whom a parenteral injection of glucocorticosteroids is anticipated during the Open-Label Treatment Period. 10. Concomitant use of nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors, unless the patient is on a stable dose for at least 2 weeks prior to randomization (Visit 2). 11. Use of any opiate analgesic at average daily doses of >30 mg/day of morphine or its equivalent or use of variable doses of any opiate analgesic within 6 weeks prior to randomization (Visit 2). 12. Have received systemic nonbiologic Ps therapy other than csDMARDs or corticosteroids as indicated above (including, but not limited to oral psoralens and ultraviolet A light therapy oral retinoids, thioguanine,hydroxyurea, sirolimus, azathioprine, fumaric acid derivatives, or 1, 25 dihydroxy vitamin D3 and analogs) or phototherapy (including either oral and topical ultraviolet A, ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to randomization (Visit 2); OR Had topical Ps treatment within the previous 2 weeks prior to randomization (Visit 2). 13.Patients with plaque Ps, who cannot avoid use of tanning booths for at least 4 weeks prior to randomization (Visit 2) and during the study. 14. Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study. 15. Have ever received efalizumab or natalizumab or other agents that target alpha-4-integrin. 16. Had a live vaccination within 12 weeks prior to randomization (Visit 2), or intend to have a live vaccination during the course of the study, or within 12 weeks of completing treatment in this st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100)Timepoint: Proportion of patients simultaneously achieving ACR50 and PASI 100 at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether ixekizumab is noninferior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by ACR50Timepoint: Proportion of patients achieving ACR50 in each treatment group at Week 24;To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by PASI 100Timepoint: Proportion of patients achieving PASI 100 in each treatment group at Week 24 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed