臨床研究等提出・公開システム

A randomized, double-blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of subcutaneous anakinra in Japanese patients with Still's disease (SJIA and AOSD)

Sobi.ANAKIN-303

Takeshi KUROSAWA

CMIC Co., Ltd.

1-1-1, Minato-ku, Shibaura, Tokyo

ClinicalTrialInformation@cmic.co.jp

CMIC Co., Ltd

CMIC Co., Ltd.

1-1-1, Minato-ku, Shibaura, Tokyo

+81-3-6779-8000

ClinicalTrialInformation@cmic.co.jp

Not Recruiting

July. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male and female patients, 8 months of age or older with a body weight >_10 kg
2. Diagnosis of Still's disease.
3. If < 16 years of age at disease onset, the diagnosis is made according to adapted ILAR criteria i.e., CARRA criteria for SJIA. If >_ 16 years of age at disease onset, the diagnosis is made according to Yamaguchi criteria for AOSD.
4. Active disease confirmed by the following three signs and symptoms. a. Active arthritis in >_ 1 joint. b. CRP > 30 mg/L. c. At least one fever episode (>_ 38.0 degree Celsius) attributable to the disease within one week before enrollment.
5. The result of tuberculosis test within 8 weeks prior to enrollment is negative.

1. Previous or current treatment with anakinra, or any other Interleukin-1 (IL-1) inhibitor except for canakinumab. Previous treatment with canakinumab is allowed if canakinumab was discontinued for reasons other than lack of efficacy and after a washout period of minimum 130 days (Refer to Exclusion Criteria 5h). Patients who have discontinued canakinumab because of insufficient effect or refractory disease are not allowed to be enrolled in the study.
2. Use of the following therapies prior to enrollment. a. Narcotic analgesics within 24 hours prior to enrollment. b. Diaminodiphenyl sulfone within 1 week prior to enrollment or etanercept within 2 weeks prior to enrollment. c. Intraarticular, intramuscular, or intravenous administration of glucocorticoids within 72h (3 days) prior to enrollment, or intravenous immunoglobulin within 4 weeks prior to enrollment. d. Intravenous immunoglobulin with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment. e. Thalidomide within 72h (3 days) prior to enrollment, cyclosporine within 5 weeks prior to enrollment, mycophenolate mofetil within 1 week prior to enrollment, 6-mercaptopurine within 48h (2 days) prior to enrollment, azathioprine within 72h (3 days) week prior to enrollment, cyclophosphamide within 96h (4 days) prior to enrollment, chlorambucil (not approved in Japan) within 48h (2 days) prior to enrollment, or any other immunosuppressant within 12 weeks prior to enrollment. f. Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medication within 4 half-lives prior to enrollment. g. Rituximab within 13 weeks prior to enrollment. h. Canakinumab within 130 days prior to enrollment.
3. Live vaccines within 4 weeks prior to enrollment.
4. Known presence or suspicion of active, chronic, or recurrent bacterial, fungal, or viral infections, including but not limited to tuberculosis, HIV infection, Covid-19 infection, or hepatitis B or C infection at baseline. Patients with acute or chronic HBV (i.e., with positive HBsAg, except if a documented history of vaccination), or at risk of HBV reactivation (i.e., with negative HBsAg AND positive anti-HBc) will be excluded.
5. Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests. a. AST or ALT > 5 x upper limit of normal (ULN), or b. AST or ALT > 3 x ULN accompanied by elevated bilirubin > 2 x ULN.
6. Presence of severe chronic kidney disease (CKD) grades 4 and 5 (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m2).
7. Presence of neutropenia (absolute neutrophil count [ANC] < 1.5 x 10^9/L).
8. Presence of thrombocytopenia (platelets count < 100 x 10^9/L).
9. Presence or suspicion of MAS at baseline.
10. History or diagnosis of MAS within the last 4 weeks prior to enrollment.

Both

Systemic juvenile idiopathic arthritis(SJIA)., adult-onset Still's disease (AOSD)

- Pediatric and adult patients weighing >_ 50kg:Anakinra 100mg/day
- Pediatric and adult patients weighing < 50 kg:should be dosed by body weight with a starting dose of 2mg/kg/day of anakinra (with a maximum of 100mg/day)

ACR30 response at Week 2 with absence of fever attributable to the disease during the 7 days preceding Week 2 visit.

+81-44-977-8111

June. 15, 2022

No

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