Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002631-33-NL
• Date of registration: 17/09/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis
• Scientific title: Randomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209
• Date of first enrolment: 23/02/2009
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002631-33
• 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: 4

Countries of recruitment

Germany, Netherlands, United Kingdom

Contacts

• Name: Clinical operations Manager
• Affiliation: Harrison Clinical Research Benelux n.v.

• Name: Clinical operations Manager
• Affiliation: Harrison Clinical Research Benelux n.v.

Key inclusion & exclusion criteria

Inclusion criteria:
• Male and female patients aged 18-65
• A diagnosis of moderate to severe AS fulfilling the modified New York criteria for a diagnosis of AS and whose disease is not controlled on NSAIDS (on at least one NSAID over a period of at least 3 months at maximum dose).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Male or female patients who plan to conceive during the time course of the study and for 6 months following the second dose.
• Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
• Previous use of immunosuppressive agents such as cyclosporine without the necessary wash-out period
• History of severe allergy to food or drugs
• Positive tuberculin test
• Total ankylosis of the spine (end stage disease)
• Patients with psoriatic arthritis


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

Health Condition(s) or Problem(s) studied

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

ankylosing spondylitis
MedDRA version: 13.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: AIN457
Product Code: AIN457
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 47-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): PART 1: Percentage of ASAS20 responders
PART 2: Change in BASDAI response

Main Objective: • Part 1: To evaluate the efficacy of AIN457 at 6 weeks based ASAS20 response (ASAS includes measures of patient global assessment, inflammatory back pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and morning stiffness by BASDAI).
• Part 2: To evaluate the efficacy of lower doses of AIN457 at 6 weeks based on the change in BASDAI score

Secondary Objective: • 20% and 40% improvement compared to baseline as measured by ASAS response
• ASAS 5/6 response (based on ASAS plus Bath Ankylosing Spondylitis Metrology Index (BASMI) and C reactive protein (acute phase reactant)
• Physician’s global assessment of disease activity
• Quality of Life Questionnaires (SF-36 and ASQoL)
• 44-joint count
• Maastricht Ankylosing Spondylitis Enthesis Score (MASES) and Leeds enthesis index (LEI)

Timepoint(s) of evaluation of this end point: Week 6

Secondary Outcome(s)

Secondary end point(s): • 20% and 40% improvement compared to baseline as measured by ASAS response
• ASAS 5/6 response (based on ASAS plus Bath Ankylosing Spondylitis Metrology Index (BASMI) and C reactive protein (acute phase reactant)
• Physician’s global assessment of disease activity
• Quality of Life Questionnaires (SF-36 and ASQoL)
• 44-joint count
• Maastricht Ankylosing Spondylitis Enthesis Score (MASES) and Leeds enthesis index (LEI)

Timepoint(s) of evaluation of this end point: At screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28:
• 20% and 40% improvement compared to baseline as measured by ASAS response
• ASAS 5/6 response (based on ASAS plus Bath Ankylosing Spondylitis Metrology Index (BASMI) and C reactive protein (acute phase reactant)
• Physician’s global assessment of disease activity
At baseline and weeks 4, 12 and 28:
• Quality of Life Questionnaires (SF-36 and ASQoL)
• 44-joint count
• Maastricht Ankylosing Spondylitis Enthesis Score (MASES) and Leeds enthesis index (LEI)

Secondary ID(s)

2008-002631-33-GB

CAIN457A2209

Source(s) of Monetary Support

Novartis Pharma AG