Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis

Randomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00809159

Enrollment

Registered

2008-12-17

Start date

2009-03-31

Completion date

2011-05-31

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis

Brief summary

Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as treatment of moderate to severe ankylosing spondylitis (AS).

Interventions

DRUGPlacebo

Placebo to AIN457

BIOLOGICALAIN457

AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with moderate to severe AS fulfilling the modified New York criteria for a diagnosis of AS and whose disease was not controlled on NSAIDS (on at least one NSAID over a period of at least 3 months at maximum dose). Minimum disease activity for inclusion of patients was assessed based on the ASAS core set domains: back pain & nocturnal pain score ≥ 4 despite concurrent NSAID use, PLUS a BASDAI score ≥ 4. Elevated CRP or ESR was not mandatory for study inclusion * No evidence of liver disease or liver injury as indicated by abnormal liver function tests such as serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvic transaminase (SGPT/ALT), gamma glutamyl transpeptidase (GGT), alkaline phosphatase, or serum bilirubin. The investigator was guided by criteria as outlined under

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Achieved ASAS20 Response	6 Weeks	Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2	6 Weeks	ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)

Secondary

Measure	Time frame	Description
Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Baseline, week 6, week 28	The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation
Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.
Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.
PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 8,15,29,week, 6, 10,12,16,20,24,28	MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).
PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28	ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)
PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28	BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28	The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28	MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).
Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28	The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.
Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8	The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.
PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2	Week 28	Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28
Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28	a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data

Countries

Germany, Netherlands, United Kingdom, United States

Participant flow

Recruitment details

Part 1 of the study, patients received 2 infusions spaced three weeks apart of 10 mg/kg AIN457 or placebo, and in Part 2 of the study, patients received 2 infusions spaced three weeks apart of 0.1 mg/kg, 1.0 mg/kg or 10 mg/kg AIN457, respectively.

Pre-assignment details

Part 1 participants were randomized 4:1 to receive AIN457A or placebo. Part 2, the randomization ratio was to be 2:2:1 for the three dose groups, 0.1 mg/kg, 1 mg/kg and 10 mg/kg. More subjects were randomized to the 0.1 and 1mg/kg dose groups as compared to the 10 mg/kg group, as 24 subjects were already randomized to the 10 mg/kg group in Part 1.

Participants by arm

Arm	Count
Parts 1 and 2 - AIN457A 10 mg/kg AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.	30
Part 1 and 2 - AIN457 1.0 mg/kg AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22	12
Part 1 and 2 - AIN457 0.1 mg/kg AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22	12
Part 1 and 2 - Placebo Placebo to AIN457A was administered intravenously as a single dose	6
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Part 1	Adverse Event	1	1	0	0	0	0
Part 1	Lost to Follow-up	1	0	0	0	0	0
Part 1	Unsatisfactory therapeutic effect	3	1	0	0	0	0
Part 1	Withdrawal by Subject	3	1	0	0	0	0
Part 1 and 2	Administrative problems	0	0	0	1	0	0
Part 1 and 2	Adverse Event	0	0	1	0	1	1
Part 1 and 2	Lost to Follow-up	0	0	1	1	0	0
Part 1 and 2	Unsatisfactory therapeutic effect	0	0	4	3	5	1
Part 1 and 2	Withdrawal by Subject	0	0	4	0	0	1

Baseline characteristics

Characteristic	Parts 1 and 2 - AIN457A 10 mg/kg	Part 1 and 2 - AIN457 1.0 mg/kg	Part 1 and 2 - AIN457 0.1 mg/kg	Part 1 and 2 - Placebo	Total
Age, Continuous	40.7 Years STANDARD_DEVIATION 9.69	47.2 Years STANDARD_DEVIATION 10.5	42.8 Years STANDARD_DEVIATION 9.17	45.0 Years STANDARD_DEVIATION 9.96	42.8 Years STANDARD_DEVIATION 9.88
Sex: Female, Male Female	11 Participants	6 Participants	4 Participants	1 Participants	22 Participants
Sex: Female, Male Male	19 Participants	6 Participants	8 Participants	5 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	27 / 30	10 / 12	9 / 12	5 / 6
serious Total, serious adverse events	2 / 30	1 / 12	0 / 12	1 / 6

Outcome results

Primary

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2

ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)

Time frame: 6 Weeks

Population: Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Part 1 - AIN457A 10 mg/kg	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2	-1.87 Units on a scale
Part 1 - Placebo	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2	-2.0151 Units on a scale
Part 1 and 2 - AIN457 0.1 mg/kg	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2	-1.2002 Units on a scale
Part 1 and 2 - Placebo	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2	-1.0577 Units on a scale

Primary

Percentage of Participants Who Achieved ASAS20 Response

Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores

Time frame: 6 Weeks

Arm	Measure	Value (NUMBER)
Part 1 - AIN457A 10 mg/kg	Percentage of Participants Who Achieved ASAS20 Response	59.2 Percentage
Part 1 - Placebo	Percentage of Participants Who Achieved ASAS20 Response	24.5 Percentage

Secondary

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2

The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.

Time frame: Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 10 (n=24,11,9,3)	-1.6246 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.3863 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 6 (n=26,11,11,3)	-1.8713 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.7373 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 24 (n=20,8,5,3)	-1.1318 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 15 (n=28,12,11,5)	-1.7094 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 8 (n=28,12,11,6)	-1.7011 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 20 (n=21,9,6,3)	-1.2072 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 16 (n=24,10,8,3)	-1.3990 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 29 (n=28,12,11,6)	-2.2530 Score
Part 1 - AIN457A 10 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 12 (n=24,12,11,3)	-1.4744 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 29 (n=28,12,11,6)	-2.4237 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 8 (n=28,12,11,6)	-1.2793 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 15 (n=28,12,11,5)	-2.1256 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 6 (n=26,11,11,3)	-2.0151 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.6994 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 10 (n=24,11,9,3)	-1.7402 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 12 (n=24,12,11,3)	-1.3755 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 16 (n=24,10,8,3)	-2.3081 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 20 (n=21,9,6,3)	-1.4070 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 24 (n=20,8,5,3)	-1.0035 Score
Part 1 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.8980 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 29 (n=28,12,11,6)	-1.3886 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 10 (n=24,11,9,3)	-1.0800 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 20 (n=21,9,6,3)	-1.1596 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 12 (n=24,12,11,3)	-1.6834 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 8 (n=28,12,11,6)	-1.2920 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 16 (n=24,10,8,3)	-1.7628 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 15 (n=28,12,11,5)	-1.1263 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 6 (n=26,11,11,3)	-1.2002 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 28 (n=28,11,11,5)	-1.2227 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.2020 Score
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 24 (n=20,8,5,3)	-0.8020 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.7839 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.9722 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 10 (n=24,11,9,3)	-0.8527 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 20 (n=21,9,6,3)	-1.5864 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 24 (n=20,8,5,3)	-1.2048 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 8 (n=28,12,11,6)	-1.0837 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 12 (n=24,12,11,3)	-1.3529 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Day 15 (n=28,12,11,5)	-0.6417 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.4619 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 6 (n=26,11,11,3)	-1.0577 Score
Part 1 and 2 - Placebo	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2	Week 16 (n=24,10,8,3)	-1.4083 Score

Secondary

Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.

The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.

Time frame: SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 28 SF36 Mental component (n=21,4)	41.65 Score	Standard Deviation 9.86
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 12 SF36 Mental component (n=20,3)	43.45 Score	Standard Deviation 10.56
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 28 SF36 Physical component (n=21,4)	32.2 Score	Standard Deviation 5.68
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Baseline SF36 physical component (n=22,6)	31.42 Score	Standard Deviation 5.2
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Day 29 ASQoL (n=21,6)	-2.9 Score	Standard Deviation 4.04
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Week 12 ASQoL (n=18,3)	-2.3 Score	Standard Deviation 3.05
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 12 SF36 Physical component (n=20,3)	32.84 Score	Standard Deviation 6.39
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Week 28 ASQoL (n=20,4)	-1.2 Score	Standard Deviation 3.71
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Baseline SF36 Mental component (n= 22,6)	38.71 Score	Standard Deviation 10.78
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Week 28 ASQoL (n=20,4)	-1.3 Score	Standard Deviation 2.06
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Baseline SF36 Mental component (n= 22,6)	39.57 Score	Standard Deviation 14.63
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Baseline SF36 physical component (n=22,6)	30.11 Score	Standard Deviation 6.71
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 12 SF36 Mental component (n=20,3)	56.57 Score	Standard Deviation 5.39
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 12 SF36 Physical component (n=20,3)	28.95 Score	Standard Deviation 1.8
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 28 SF36 Mental component (n=21,4)	40.51 Score	Standard Deviation 15.22
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Week 28 SF36 Physical component (n=21,4)	33.96 Score	Standard Deviation 8.73
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Week 12 ASQoL (n=18,3)	0.0 Score	Standard Deviation 1
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.	Change from Baseline to Day 29 ASQoL (n=21,6)	-0.7 Score	Standard Deviation 2.58

Secondary

Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.

The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.

Time frame: SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Mental component (n=25,11,10,3)	44.37 Score	Standard Deviation 11.05
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Physical component (n=26,11,10,4)	31.85 Score	Standard Deviation 5.3
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Mental component (n=26,11,10,4)	40.94 Score	Standard Deviation 10.56
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Mental component (n=27,12,12,6)	38.97 Score	Standard Deviation 10.91
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Physical component (n=25,11,10,3)	32.71 Score	Standard Deviation 6.24
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 28 ASQoL(n=25,11,9,4)	-1.4 Score	Standard Deviation 3.37
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 12 ASQoL(n=23,11,9,3)	-2.7 Score	Standard Deviation 2.91
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Physical component (n=27,12,12,6)	30.95 Score	Standard Deviation 6.34
Part 1 - AIN457A 10 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Day 29 ASQoL(n=26,11,10,6)	-3.2 Score	Standard Deviation 3.78
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Day 29 ASQoL(n=26,11,10,6)	-3.1 Score	Standard Deviation 2.63
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 12 ASQoL(n=23,11,9,3)	-2.7 Score	Standard Deviation 4.71
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 28 ASQoL(n=25,11,9,4)	-1.3 Score	Standard Deviation 3.66
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Mental component (n=27,12,12,6)	39.46 Score	Standard Deviation 11.95
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Mental component (n=25,11,10,3)	38.45 Score	Standard Deviation 10.13
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Physical component (n=25,11,10,3)	31.3 Score	Standard Deviation 7.67
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Mental component (n=26,11,10,4)	36.6 Score	Standard Deviation 10.3
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Physical component (n=26,11,10,4)	29.95 Score	Standard Deviation 6.92
Part 1 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Physical component (n=27,12,12,6)	26.17 Score	Standard Deviation 7.63
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Day 29 ASQoL(n=26,11,10,6)	-0.7 Score	Standard Deviation 2.26
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Mental component (n=26,11,10,4)	46.96 Score	Standard Deviation 9.67
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 28 ASQoL(n=25,11,9,4)	-0.9 Score	Standard Deviation 2.15
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 12 ASQoL(n=23,11,9,3)	-1.3 Score	Standard Deviation 3.16
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Physical component (n=27,12,12,6)	33.53 Score	Standard Deviation 7.47
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Physical component (n=26,11,10,4)	35.54 Score	Standard Deviation 5.9
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Physical component (n=25,11,10,3)	35.81 Score	Standard Deviation 5.29
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Mental component (n=27,12,12,6)	51.9 Score	Standard Deviation 8.7
Part 1 and 2 - AIN457 0.1 mg/kg	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Mental component (n=25,11,10,3)	49.7 Score	Standard Deviation 11.74
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 28 ASQoL(n=25,11,9,4)	-1.3 Score	Standard Deviation 2.06
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Mental component (n=27,12,12,6)	39.57 Score	Standard Deviation 14.63
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Baseline SF36 Physical component (n=27,12,12,6)	30.11 Score	Standard Deviation 6.71
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Mental component (n=25,11,10,3)	56.57 Score	Standard Deviation 5.39
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 12 SF36 Physical component (n=25,11,10,3)	28.05 Score	Standard Deviation 1.8
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Mental component (n=26,11,10,4)	40.51 Score	Standard Deviation 15.22
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Week 28 SF36 Physical component (n=26,11,10,4)	33.96 Score	Standard Deviation 8.73
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Day 29 ASQoL(n=26,11,10,6)	-0.7 Score	Standard Deviation 2.58
Part 1 and 2 - Placebo	Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.	Change from Baseline to Week 12 ASQoL(n=23,11,9,3)	0.0 Score	Standard Deviation 1

Secondary

Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1

The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation

Time frame: Baseline, week 6, week 28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Baseline (n=22,5)	9.2 Score	Standard Deviation 8.87
Part 1 - AIN457A 10 mg/kg	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Week 6 (n=22,3)	6.6 Score	Standard Deviation 6.56
Part 1 - AIN457A 10 mg/kg	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Week 28 (n=16,5)	5.7 Score	Standard Deviation 6.2
Part 1 - Placebo	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Baseline (n=22,5)	20.6 Score	Standard Deviation 20.18
Part 1 - Placebo	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Week 6 (n=22,3)	21.0 Score	Standard Deviation 24.56
Part 1 - Placebo	Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1	Week 28 (n=16,5)	19.0 Score	Standard Deviation 19.33

Secondary

Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2

BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement

Time frame: Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.036 Score	Standard Deviation 0.7345
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.376 Score	Standard Deviation 0.8686
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 8 (n=26,11,11,3)	-0.238 Score	Standard Deviation 0.81
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.281 Score	Standard Deviation 0.8138
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 24 (n=20,8,5,3)	-0.250 Score	Standard Deviation 0.7564
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.143 Score	Standard Deviation 0.9168
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 15 (n=28,12,12,5)	-0.200 Score	Standard Deviation 0.7364
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 8 (n=28,12,12,5)	-0.121 Score	Standard Deviation 0.7969
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 16 (n=24,10,8,3)	-0.200 Score	Standard Deviation 0.8299
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.384 Score	Standard Deviation 0.8887
Part 1 - AIN457A 10 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.157 Score	Standard Deviation 0.8404
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 24 (n=20,8,5,3)	0.200 Score	Standard Deviation 0.5657
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 8 (n=28,12,12,5)	-0.117 Score	Standard Deviation 0.6293
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 15 (n=28,12,12,5)	-0.383 Score	Standard Deviation 0.5937
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.417 Score	Standard Deviation 0.7259
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.436 Score	Standard Deviation 0.7256
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 8 (n=26,11,11,3)	-0.518 Score	Standard Deviation 1.0925
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.200 Score	Standard Deviation 0.9077
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.267 Score	Standard Deviation 0.7738
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 16 (n=24,10,8,3)	-0.400 Score	Standard Deviation 0.7424
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.356 Score	Standard Deviation 0.6064
Part 1 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.182 Score	Standard Deviation 0.9527
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.455 Score	Standard Deviation 0.9883
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 28 (n=28,11,11,5)	-0.230 Score	Standard Deviation 0.8145
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.633 Score	Standard Deviation 1.0912
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 15 (n=28,12,12,5)	-0.350 Score	Standard Deviation 0.7775
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 8 (n=28,12,12,5)	-0.233 Score	Standard Deviation 0.9335
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.291 Score	Standard Deviation 0.8961
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.400 Score	Standard Deviation 0.6325
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 16 (n=24,10,8,3)	-0.550 Score	Standard Deviation 0.9304
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 24 (n=20,8,5,3)	-0.800 Score	Standard Deviation 1.1045
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 8 (n=26,11,11,3)	-0.509 Score	Standard Deviation 0.9523
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.382 Score	Standard Deviation 1.0713
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 8 (n=26,11,11,3)	-0.133 Score	Standard Deviation 0.611
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.067 Score	Standard Deviation 0.4163
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 15 (n=28,12,12,5)	0.160 Score	Standard Deviation 0.8764
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 24 (n=20,8,5,3)	0.400 Score	Standard Deviation 0.7211
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 28 (n=28,11,11,5)	0.400 Score	Standard Deviation 0.469
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 16 (n=24,10,8,3)	0.400 Score	Standard Deviation 0.8
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 8 (n=28,12,12,5)	0.240 Score	Standard Deviation 0.2966
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.200 Score	Standard Deviation 1.5875
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 6 (n=27,11,11,3)	0.133 Score	Standard Deviation 0.611
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Day 29 (n=28,12,11,6)	0.100 Score	Standard Deviation 0.2098
Part 1 and 2 - Placebo	Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.200 Score	Standard Deviation 0.6928

Secondary

Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1

MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).

Time frame: Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 6 (n=22,3)	-1.5 Score	Standard Deviation 3.1
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 12 (n=20,3)	-1.2 Score	Standard Deviation 3.09
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 29 (n=23,6)	-1.0 Score	Standard Deviation 2.8
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 16 (n=30,3)	-0.9 Score	Standard Deviation 3.69
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 8 (n=21,3)	-1.0 Score	Standard Deviation 2.77
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 20 (n=18,3)	0.2 Score	Standard Deviation 3.55
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 15 (n=23,5)	-1.3 Score	Standard Deviation 2.53
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 24 (n=17,3)	-1.3 Score	Standard Deviation 2.11
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 10 (n=20,3)	-1.3 Score	Standard Deviation 3.24
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 28 (n=23,5)	-0.4 Score	Standard Deviation 3.86
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 8 (n=23,6)	-1.3 Score	Standard Deviation 2.46
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 28 (n=23,5)	1.2 Score	Standard Deviation 1.3
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 8 (n=23,6)	0.7 Score	Standard Deviation 1.37
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 15 (n=23,5)	2.4 Score	Standard Deviation 2.51
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Day 29 (n=23,6)	-0.3 Score	Standard Deviation 1.97
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 6 (n=22,3)	-0.3 Score	Standard Deviation 0.58
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 8 (n=21,3)	0.0 Score	Standard Deviation 0
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 10 (n=20,3)	-0.3 Score	Standard Deviation 0.58
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 12 (n=20,3)	-0.3 Score	Standard Deviation 0.58
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 16 (n=30,3)	-0.3 Score	Standard Deviation 0.58
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 20 (n=18,3)	0.3 Score	Standard Deviation 1.53
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1	Week 24 (n=17,3)	-0.3 Score	Standard Deviation 0.58

Secondary

Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2

Time frame: Day 8,15,29,week, 6, 10,12,16,20,24,28

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 10 (n=25,11,10,3)	-1.360 Score	Standard Deviation 3.3277
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.154 Score	Standard Deviation 2.9758
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 6 (n=27,11,11,3)	-1.556 Score	Standard Deviation 3.2026
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.238 Score	Standard Deviation 3.8458
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 15 (n=28,12,12,5)	-1.393 Score	Standard Deviation 2.7667
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 24 (n=20,8,5,3)	-1.400 Score	Standard Deviation 2.2572
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 16 (n=24,10,8,3)	-1.042 Score	Standard Deviation 3.7819
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 12 (n=25,12,11,3)	-1.280 Score	Standard Deviation 3.2342
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 29 (n=28,12,11,6)	-1.143 Score	Standard Deviation 2.9779
Part 1 - AIN457A 10 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 8 (n=28,12,12,6)	-1.321 Score	Standard Deviation 2.7763
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 8 (n=28,12,12,6)	-1.917 Score	Standard Deviation 2.2344
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 15 (n=28,12,12,5)	-1.167 Score	Standard Deviation 1.9924
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 29 (n=28,12,11,6)	-2.083 Score	Standard Deviation 2.2344
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.339 Score	Standard Deviation 3.1318
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 8 (n=26,11,11,3)	-1.273 Score	Standard Deviation 1.6787
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 10 (n=25,11,10,3)	-1.091 Score	Standard Deviation 3.145
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 12 (n=25,12,11,3)	-1.167 Score	Standard Deviation 4.1304
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 16 (n=24,10,8,3)	-0.600 Score	Standard Deviation 3.4705
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.333 Score	Standard Deviation 3.7749
Part 1 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 24 (n=20,8,5,3)	-1.000 Score	Standard Deviation 3.7417
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.545 Score	Standard Deviation 0.6876
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.800 Score	Standard Deviation 0.9189
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 8 (n=28,12,12,6)	-0.583 Score	Standard Deviation 1.0836
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.636 Score	Standard Deviation 1.804
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 15 (n=28,12,12,5)	-1.167 Score	Standard Deviation 1.9462
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 16 (n=24,10,8,3)	0.500 Score	Standard Deviation 1.6903
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 24 (n=20,8,5,3)	0.600 Score	Standard Deviation 1.9494
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.364 Score	Standard Deviation 1.0269
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 20 (n=21,9,6,3)	-0.667 Score	Standard Deviation 1.3663
Part 1 and 2 - AIN457 0.1 mg/kg	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 8 (n=26,11,11,3)	0.455 Score	Standard Deviation 2.2523
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 6 (n=27,11,11,3)	-0.333 Score	Standard Deviation 0.5774
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 20 (n=21,9,6,3)	0.333 Score	Standard Deviation 1.5275
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 16 (n=24,10,8,3)	-0.333 Score	Standard Deviation 0.5774
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 10 (n=25,11,10,3)	-0.333 Score	Standard Deviation 0.5774
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 15 (n=28,12,12,5)	2.400 Score	Standard Deviation 2.51
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 8 (n=28,12,12,6)	0.667 Score	Standard Deviation 1.3663
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Day 29 (n=28,12,11,6)	-0.333 Score	Standard Deviation 1.9664
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 12 (n=25,12,11,3)	-0.333 Score	Standard Deviation 0.5774
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 8 (n=26,11,11,3)	0.0 Score	Standard Deviation 0
Part 1 and 2 - Placebo	Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2	Week 24 (n=20,8,5,3)	-0.333 Score	Standard Deviation 0.5774

Secondary

Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined

a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data

Time frame: Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28

Arm	Measure	Group	Value (NUMBER)
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 20 (n=28,12,11,6)	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 28 (n=28,11,11,6)	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 28 (n=28,11,11,6)	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 12 (n=27,12,11,6)	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 6 (n=27,11,11,6)	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 24 (n=28,12,11,6)	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 24 (n=28,12,11,6)	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 8 (n=28,12,12,6)	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 10 (28,11,11,6)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 16 (n=28,12,11,6)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 16 (n=28,12,11,6)	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 15 (n=28,12,12,5)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 20 (n=28,12,11,6)	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 29 (28,12,11,6)	10 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 8 (n=28,12,12,6)	12 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 8 (28,12,12,6)	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 12 (n=28,12,11,6)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 15 (n=28,12,12,5)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 29 (n=28,12,11,6)	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 6 (n=27,11,11,6)	16 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 28 (n=28,11,10,6)	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 10 (n=27,11,10,6)	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 8 (n=28,11,11,6)	10 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 15 (n=28,12,12,5)	11 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 10 (n=27,11,10,6)	11 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 8 (n=28,11,11,6)	7 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 12 (n=27,12,11,6)	12 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 8 (n=28,11,11,6)	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 16 (n=28,12,11,6)	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 6 (n=28,11,11,6)	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 20 (n=28,12,11,6)	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 29 (n=28,12,11,6)	14 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 24 (n=28,12,11,6)	7 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 10 (n=27,11,10,6)	5 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 15 (n=28,12,12,5)	7 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 15 (n=28,12,12,5)	5 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 28 (n=28,11,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 28 (n=28,11,10,6)	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 24 (n=28,12,11,6)	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 10 (n=27,11,10,6)	4 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 6 (n=27,11,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 24 (n=28,12,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 29 (n=28,12,11,6)	5 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 8 (n=28,11,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 24 (n=28,12,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 20 (n=28,12,11,6)	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 6 (n=27,11,11,6)	4 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 10 (28,11,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 8 (n=28,12,12,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 29 (n=28,12,11,6)	6 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 12 (n=27,12,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 12 (n=27,12,11,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 16 (n=28,12,11,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 28 (n=28,11,11,6)	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 20 (n=28,12,11,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 6 (n=28,11,11,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 15 (n=28,12,12,5)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 16 (n=28,12,11,6)	5 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 8 (n=28,11,11,6)	4 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 20 (n=28,12,11,6)	4 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 29 (28,12,11,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 8 (n=28,11,11,6)	4 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 12 (n=28,12,11,6)	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 16 (n=28,12,11,6)	5 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 8 (28,12,12,6)	3 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 8 (n=28,12,12,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 10 (n=27,11,10,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 8 (n=28,12,12,6)	6 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 15 (n=28,12,12,5)	4 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 29 (n=28,12,11,6)	4 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 8 (n=28,12,12,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 15 (n=28,12,12,5)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 29 (28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 8 (28,12,12,6)	5 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 15 (n=28,12,12,5)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 6 (n=27,11,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 8 (n=28,11,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 29 (n=28,12,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 12 (n=27,12,11,6)	4 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 16 (n=28,12,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 20 (n=28,12,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 24 (n=28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 28 (n=28,11,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 6 (n=27,11,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 8 (n=28,11,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 10 (28,11,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 12 (n=27,12,11,6)	3 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 16 (n=28,12,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 20 (n=28,12,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 24 (n=28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 28 (n=28,11,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 6 (n=28,11,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 8 (n=28,11,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 10 (n=27,11,10,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 12 (n=28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 16 (n=28,12,11,6)	2 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 20 (n=28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 24 (n=28,12,11,6)	1 Participants
Part 1 and 2 - AIN457 0.1 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 28 (n=28,11,10,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 20 (n=28,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 20 (n=28,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 28 (n=28,11,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 16 (n=28,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 12 (n=27,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 29 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 6 (n=28,11,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 10 (n=27,11,10,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 8 (n=28,11,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 15 (n=28,12,12,5)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 8 (n=28,11,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 6 (n=27,11,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 15 (n=28,12,12,5)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 28 (n=28,11,10,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 10 (n=27,11,10,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 8 (28,12,12,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 29 (28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 24 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 12 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at day 8 (n=28,12,12,6)	2 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at week 16 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 12 (n=27,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 15 (n=28,12,12,5)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 16 (n=28,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 10 (28,11,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 8 (n=28,11,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at day 8 (n=28,12,12,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 20 (n=28,12,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 6 (n=27,11,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 28 (n=28,11,11,6)	1 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS 5/6 at day 29 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS40 at week 24 (n=28,12,11,6)	0 Participants
Part 1 and 2 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined	ASAS20 at week 24 (n=28,12,11,6)	0 Participants

Secondary

Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1

ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)

Time frame: Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28

Arm	Measure	Group	Value (NUMBER)
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 15	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 6	7 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 6	14 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 8	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 29	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 10	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 8	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 12	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 8	4 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 16	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 10	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 20	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 8	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 24	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 12	9 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 28	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 29	11 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 6	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 16	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 8	7 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 15	5 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 10	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 20	6 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 12	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 15	4 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 16	4 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 24	7 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 20	2 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 29	8 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 24	3 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 28	7 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 28	1 Participants
Part 1 - AIN457A 10 mg/kg	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 8	9 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 28	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 8	2 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 15	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at Day 29	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 8	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 15	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at Day 29	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 8	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 15	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at Day 29	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 6	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 8	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 10	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 12	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 16	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 20	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 24	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS20 at week 28	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 6	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 8	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 10	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 12	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 16	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 20	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 24	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS40 at week 28	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 6	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 8	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 10	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 12	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 16	0 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 20	1 Participants
Part 1 - Placebo	Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1	ASAS 5/6 at week 24	0 Participants

Secondary

Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1

Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.

Time frame: Week 28

Population: Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.

Arm	Measure	Value (MEDIAN)
Part 1 - AIN457A 10 mg/kg	Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1	21.07 Days

Secondary

Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2

Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.

Time frame: Week 28

Arm	Measure	Value (MEDIAN)
Part 1 - AIN457A 10 mg/kg	Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2	21.08 Days
Part 1 - Placebo	Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2	21.08 Days
Part 1 and 2 - AIN457 0.1 mg/kg	Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2	21.12 Days

Secondary