A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

NCT05814159 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Sobi.ANAKIN-303
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief Summary

A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis \[SJIA\] and Adult-onset Still's disease \[AOSD\]).

Conditions

Still's Disease, Juvenile Onset; Still's Disease, Adult-Onset

Outcome Measures

Primary Outcomes (6)

• An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

• An improvement of ≥ 30% from baseline in patient/parent global assessment of overall well-being (VAS).

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

• An improvement of ≥ 30% from baseline in number of joints with active arthritis.

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

• An improvement of ≥ 30% from baseline in number of joints with limitation of motion.

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

• An improvement of ≥ 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

• An improvement of ≥ 30% from baseline in C-reactive protein (CRP) (mg/L).

  ACR30 response with absence of fever attributable to the disease during the 7 days

  Week 2

Secondary Outcomes (56)

• Change in CRP.

  Week 2

• Change in ferritin.

  Week 2

• Change in haemoglobin.

  Week 2

• Change in platelets count.

  Week 2

• Change in white blood cells count.

  Week 2

Study Arms (2)

Anakinra

EXPERIMENTAL

100 mg/day or 2 mg/kg/day of subcutaneous anakinra for those with a body weight ≥50 kg or \<50 kg, respectively.

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

Corresponding volume to 100 mg/day or 2 mg/kg/day

Drug: Placebo

Interventions

Anakinra DRUG

sub cutaneous daily injection

Also known as: Kineret

Anakinra

Placebo DRUG

sub cutaneous daily injection

Placebo

Eligibility Criteria

• Age: 8 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients, 8 months of age or older with a body weight ≥ 10 kg
• Diagnosis of Still's disease
• If \< 16 years of age at disease onset, the diagnosis is madeaccording 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.
• 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.
• The result of tuberculosis test within 8 weeks prior to enrollment is negative.

You may not qualify if:

• 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. Patients who have discontinued canakinumab because of insufficient effect or refractory disease are not allowed to be enrolled in the study.
• Use of the following therapies prior to enrollment.
• Narcotic analgesics within 24 hours prior to enrollment.
• Diaminodiphenyl sulfone within 1 week prior to enrollment or etanercept within 2 weeks prior to enrollment.
• Intraarticular, intramuscular, or intravenous administration of glucocorticoids within 72h(3 days) prior to enrollment, or intravenous immunoglobulin within 4 weeks prior to enrollment.
• Intravenous immunoglobulins with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment.
• 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) prior to enrollment, cyclophosphamide within 96h(4 days) prior to enrollment, chlorambucil (not approved inJapan) within 48h(2 days) prior to enrollment, or any other immunosuppressants within 12 weeks prior to enrollment.
• Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medications within 4 half-lives prior to enrollment.
• Rituximab within 13 weeks prior to enrollment.
• Canakinumab within 130 days prior to enrollment
• Live vaccines within 4 weeks prior to enrollment.
• 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.
• Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests.
• Presence of severe chronic kidney disease (CKD) grades 4 and 5.
• Presence of neutropenia (absolute neutrophil count \[ANC\] \< 1.5 x 10\^9/L).

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• CMIC Co, Ltd. Japan: collaborator

Study Sites (8)

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Location

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, Japan

Location

Yokohama City University Hospital (Hematology and Clinical Immunology)

Yokohama, Kanagawa, Japan

Location

Shinshu University

Matsumoto, Nagano, Japan

Location

Tokyo Medical And Dental University Hospital

Bunkyō-Ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Location

Gifu University Hospital

Gifu, Japan

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Still's Disease, Adult-Onset

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Masaaki Mori, MD

  St. Marianna University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: April 14, 2023
• Study Start: August 24, 2022
• Primary Completion: December 10, 2025
• Study Completion (Estimated): June 24, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)