JPRN-jRCT2071210076
Recruiting
Phase 3
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC
Hibi Kazushige0 sites36 target enrollmentOctober 15, 2021
ConditionsSystemic Lupus Erythematosus
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Hibi Kazushige
- Enrollment
- 36
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for 24 weeks prior or more to signing the ICF
- •2\. To be eligible a patient must have SLEDAI\-2K 6 points or more and Clinical SLEDAI\-2K score 4 points or more at screening
- •3\. BILAG2004 with at least 1 of the following:
- •\- BILAG2004 level A disease in 1 organ system or more
- •\- BILAG2004 level B disease in 2 organ systems or more
- •4\. Physician's Global Assessment (PGA) score 1\.0 or more on a 0 to 3 VAS at Screening
- •5\. Antinuclear antibody, and/or Anti\-dsDNA and/oranti\-Smith positive at Screening,
- •6\. Must be on stable background standard therapy with DMARD, glucocorticoids or anti\-malarials alone or in combinations.
Exclusion Criteria
- •7\. Active severe or unstable neuropsychiatric SLE
- •8\. Active severe SLE\-driven renal disease
- •9\. History of any non\-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- •10\. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
- •11\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
- •12\. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
- •13\. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1\),
- •14\. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
- •15\. History of cancer, apart from:
- •a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy 3 months prior or more to Week 0 (Day 1\)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 2
A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients With Chronic Kidney Disease With Estimated Glomerular Filtration Rate (eGFR) Between 20 mL/Min/1.73 m^2 or moreChronic Kidney DiseaseJPRN-jRCT2041200106Ageishi Yuji660
Recruiting
Phase 3
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus NephritisJPRN-jRCT2011210060Ageishi Yuji360
Recruiting
Phase 3
A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic SclerosisSystemic Sclerosis, SclerodermaJPRN-jRCT2051230127Ageishi Yuji32
Not Yet Recruiting
N/A
Assessment of safety & Efficacy of cosmetic productCTRI/2023/07/055698Transformative Learning Solution Pvt Ltd
Completed
N/A
The effect of Manual Lymphatic Drainage to treat leg edema at late pregnancywomen with edema of legs in the third quarter of pregnancyReproductive Health and Childbirth - Normal pregnancyACTRN12611000272998Fapesp20