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Monoclonal Antibodies

Canakinumab for Still's Disease

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, days 3, 15, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, eos(up to week 152)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This is a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Adult Onset Still's Disease (AOSD). Interim analysis (IA) data at Week 28 and 48 from this study supports a registration submission of canakinumab in the indication of Adult still's disease (ASD) in Japan.

Eligible Conditions

Still's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, days 3, 15, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, eos(up to week 152)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, days 3, 15, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, eos(up to week 152)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 3, 15, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, eos(up to week 152) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants who achieve adapted American College of Rheumatology (ACR) 30 response at Week 8

Secondary study objectives

Absolute change from baseline in the component of adapted ACR at Day 15 and all subsequent visits: Health Assessment Questionnaire

Absolute change from baseline in the component of adapted ACR at Day 15 and all subsequent visits: Patient's global assessment of disease activity

Absolute change from baseline in the component of adapted ACR at Day 15 and all subsequent visits: Physician's global assessment of disease activity

+12 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291

50%

Diarrhoea

50%

Bronchitis

50%

Conjunctivitis

50%

Gastroenteritis

50%

Drug eruption

25%

Scleritis

25%

Ear infection

25%

Rash pruritic

25%

Hyper IgD syndrome

25%

Pyoderma gangrenosum

25%

Viral tonsillitis

25%

Pancytopenia

25%

Hepatic failure

25%

Laryngitis

25%

Familial mediterranean fever

25%

Eye allergy

25%

Eye pain

25%

Aphthous ulcer

25%

Constipation

25%

Dental caries

25%

Gastritis

25%

Haemorrhoids

25%

Nausea

25%

Stomatitis

25%

Teething

25%

Vomiting

25%

Malaise

25%

Pyrexia

25%

Influenza

25%

Nasopharyngitis

25%

Rhinitis

25%

Sialoadenitis

25%

Tonsillitis bacterial

25%

Viral upper respiratory tract infection

25%

Alanine aminotransferase increased

25%

Aspartate aminotransferase increased

25%

C-reactive protein increased

25%

Neutrophil count decreased

25%

Neutrophil count increased

25%

Serum amyloid A protein increased

25%

White blood cell count increased

25%

Dehydration

25%

Hypocalcaemia

25%

Hypophosphataemia

25%

Arthralgia

25%

Back pain

25%

Pain in extremity

25%

Pyogenic granuloma

25%

Headache

25%

Somnolence

25%

Dermatitis allergic

25%

Eczema

25%

Keloid scar

25%

Pain of skin

25%

Urticaria

25%

Skin ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events

Non-randomized Open Label crFMF, HIDS/MKD Patients

Any ACZ crFMF Patients - ACZ Events

Randomized ACZ and Placebo crFMF Pts - No Medication Events

Non-randomized Open Label TRAPS Patients

Any ACZ crFMF Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Pts - No Medication Events

Any ACZ HIDS/MKD Patients - No Medication Events

Any ACZ HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events

Any ACZ TRAPS Patients - Placebo Events

Any ACZ TRAPS Patients - ACZ Events

Any ACZ TRAPS Patients - no Medication Events

Any ACZ HIDS/MKD Patients - Placebo Events

Any ACZ crFMF Patients - No Medication Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CanakinumabExperimental Treatment1 Intervention

All participants receive canakinumab (ACZ885) as open-label study medication. Participants are administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed is 300 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Canakinumab

2011

Completed Phase 3

~3090

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