2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2011-000276-34-IT
• Date of registration: 29/12/2011
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: 2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis
• Scientific title: Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, per dimostrare l’efficacia di secukinumab a 24 settimane e per valutare la sicurezza, la tollerabilita' e l’efficacia a lungo termine fino a 2 anni in pazienti con artropatia psoriasica attiva
• Date of first enrolment: 25/07/2011
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000276-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Germany, Israel, Italy, Peru, Philippines, Poland, Russian Federation, Singapore, Slovakia, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or non-pregnant, non-lactating female subjects at least 18 years of age 2. Diagnosis of PsA classified by CASPAR criteria (see Appendix 2) and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 3. RF and anti-CCP antibodies negative. 4. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis. SEE PROTOCOL FOR MORE DETAILS
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 568
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion criteria:
1. Chest X-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. 2. Subjects who have previously been treated with more than 3 different TNFa inhibitors (investigational or approved). 3 Subjects taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine). 4 Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa, investigational or approved. 5 Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. 6 Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 and investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic arthritis
MedDRA version: 14.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks

Main Objective: To demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response in the subgroup of subjects who are TNFa inhibitor naïve.

Primary end point(s): ACR 20

Secondary Objective: • The efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR20 response in the entire study population. • The improvement (change) from baseline on secukinumab 75 or 150 mg is superior to placebo for the HAQ-DI at Week 24 in the subgroup of subjects who are TNFa inhibitor naïve. • The improvement (change) from baseline to Week 24 on secukinumab 75 and 150 mg is superior to placebo for joint/bone structural damage (van der Heijde modified total Sharp score) in the subgroup of subjects who are TNFa inhibitor naïve. • Secukinumab 75 or 150 mg is superior to placebo (as originally randomized) with regards to the proportion of subjects achieving Major Clinical Response at Week 52 in the subgroup of subjects who are TNFa inhibitor naïve.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Respectively: - 16 weeks - 52 weeks

Secondary end point(s): - HAQ-DI, and van der Heijde modified total Sharp Score - Major clinical response

Secondary ID(s)

2011-000276-34-CZ

CAIN457F2306

Source(s) of Monetary Support

Novartis Pharma AG