Trial Outcomes & Findings for Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis (NCT NCT01169844)

Last Updated: 2021-06-10

Results Overview

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Up to 64 weeks (End of the Study Treatment)

Results posted on

2021-06-10

Participant Flow

A total of 42 patients were randomized in the (CAIN457A2206) core study, of which 28 patients enrolled into the (CAIN457A2206E1) extension study.

Participant milestones

Participant milestones
Measure	AIN457/AIN457 3 mg/kg. Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Overall Study STARTED	19	9
Overall Study COMPLETED	14	8
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457/AIN457 3 mg/kg. Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Overall Study Adverse Event	0	1
Overall Study Patient withdrew consent	4	0
Overall Study Unsatisfactory therapeutic effect	1	0

Baseline Characteristics

Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457/AIN457 3 mg/kg n=19 Participants Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg n=9 Participants Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Total n=28 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 10.96 • n=5 Participants	47.9 years STANDARD_DEVIATION 6.81 • n=7 Participants	46.3 years STANDARD_DEVIATION 9.75 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Predominant race · Caucasian	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Predominant race · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic/Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 64 weeks (End of the Study Treatment)

Population: The safety population consisted of all randomized patients who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	AIN457/AIN457 3 mg/kg n=19 Participants Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg n=9 Participants Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Number of Participants With Adverse Events and Serious Adverse Events Serious Adverse Events	5 Participants	2 Participants
Number of Participants With Adverse Events and Serious Adverse Events Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 64 weeks

Population: No participants were evaluated as IL-17 concentration was not reported due to assay limitations

Total IL-17 concentration was not reported due to assay limitations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52.

Population: All participants from the safety set with quantifiable pharmacokinetic (PK) measurements and no major protocol deviations with impact on PK data were included in the Pharmacokinetic Analysis Set.

This outcome measure is assessing AIN457 Mean Serum Concentration Measured at Steady State. A competitive ELISA method was used for bioanalytical analyses and the anticipated LLOQ is 80 nanograms/mL serum.

Outcome measures

Adverse Events

AIN457/AIN457 3 mg/kg

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo/AIN457 3 mg/kg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AIN457/AIN457 3 mg/kg n=19 participants at risk Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg n=9 participants at risk Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Cardiac disorders Myocardial infarction	0.00% 0/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	11.1% 1/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Infections and infestations Viral sinusitis	5.3% 1/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	0.00% 0/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Metabolism and nutrition disorders Diabetes mellitus inadequate control	5.3% 1/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	0.00% 0/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 1/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	0.00% 0/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Musculoskeletal and connective tissue disorders Bursitis	5.3% 1/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	0.00% 0/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Musculoskeletal and connective tissue disorders Osteoarthritis	10.5% 2/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	0.00% 0/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
Nervous system disorders Sciatica	0.00% 0/19 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64	11.1% 1/9 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (862) 778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	AIN457/AIN457 3 mg/kg n=19 Participants Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.	Placebo/AIN457 3 mg/kg n=9 Participants Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Mean Serum Concentration Measured at Steady State 40/pre-inf	46.4 Microgram/millilitre (μg/mL) Standard Deviation 28.2	28.7 Microgram/millilitre (μg/mL) Standard Deviation 9.00
Mean Serum Concentration Measured at Steady State 40/post-inf	84.8 Microgram/millilitre (μg/mL) Standard Deviation 30.5	105 Microgram/millilitre (μg/mL) Standard Deviation 24.9
Mean Serum Concentration Measured at Steady State 56	33.8 Microgram/millilitre (μg/mL) Standard Deviation 8.93	31.6 Microgram/millilitre (μg/mL) Standard Deviation 7.62
Mean Serum Concentration Measured at Steady State 64	11.0 Microgram/millilitre (μg/mL) Standard Deviation 3.46	10.3 Microgram/millilitre (μg/mL) Standard Deviation 8.31
Mean Serum Concentration Measured at Steady State 0/pre-inf	2.76 Microgram/millilitre (μg/mL) Standard Deviation 4.73	0.00 Microgram/millilitre (μg/mL) Standard Deviation 0.00
Mean Serum Concentration Measured at Steady State 0/post-inf	80.0 Microgram/millilitre (μg/mL) Standard Deviation 17.7	68.8 Microgram/millilitre (μg/mL) Standard Deviation 19.1
Mean Serum Concentration Measured at Steady State 8/pre-inf	29.6 Microgram/millilitre (μg/mL) Standard Deviation 10.3	19.5 Microgram/millilitre (μg/mL) Standard Deviation 7.68
Mean Serum Concentration Measured at Steady State 8 /post-inf	99.7 Microgram/millilitre (μg/mL) Standard Deviation 22.1	88.9 Microgram/millilitre (μg/mL) Standard Deviation 25.5
Mean Serum Concentration Measured at Steady State 16/pre-inf	32.9 Microgram/millilitre (μg/mL) Standard Deviation 12.1	23.3 Microgram/millilitre (μg/mL) Standard Deviation 10.3
Mean Serum Concentration Measured at Steady State 16/post-inf	110 Microgram/millilitre (μg/mL) Standard Deviation 25.3	82.9 Microgram/millilitre (μg/mL) Standard Deviation 24.7
Mean Serum Concentration Measured at Steady State 20/pre-inf	31.3 Microgram/millilitre (μg/mL) Standard Deviation 9.00	25.4 Microgram/millilitre (μg/mL) Standard Deviation 13.0
Mean Serum Concentration Measured at Steady State 20/post-inf	111 Microgram/millilitre (μg/mL) Standard Deviation 29.9	85.5 Microgram/millilitre (μg/mL) Standard Deviation 19.9
Mean Serum Concentration Measured at Steady State 24/pre-inf	37.2 Microgram/millilitre (μg/mL) Standard Deviation 11.9	25.5 Microgram/millilitre (μg/mL) Standard Deviation 11.6
Mean Serum Concentration Measured at Steady State 24/post-inf	109 Microgram/millilitre (μg/mL) Standard Deviation 24.5	89.1 Microgram/millilitre (μg/mL) Standard Deviation 23.2
Mean Serum Concentration Measured at Steady State 28/pre-inf	37.4 Microgram/millilitre (μg/mL) Standard Deviation 10.2	22.1 Microgram/millilitre (μg/mL) Standard Deviation 9.45
Mean Serum Concentration Measured at Steady State 28/post-inf	122 Microgram/millilitre (μg/mL) Standard Deviation 20.2	96.9 Microgram/millilitre (μg/mL) Standard Deviation 18.5
Mean Serum Concentration Measured at Steady State 32/pre-inf	37.4 Microgram/millilitre (μg/mL) Standard Deviation 13.0	26.7 Microgram/millilitre (μg/mL) Standard Deviation 8.05
Mean Serum Concentration Measured at Steady State 32/post-inf	112 Microgram/millilitre (μg/mL) Standard Deviation 15.1	92.8 Microgram/millilitre (μg/mL) Standard Deviation 23.2
Mean Serum Concentration Measured at Steady State 36/pre-inf	33.4 Microgram/millilitre (μg/mL) Standard Deviation 9.49	27.3 Microgram/millilitre (μg/mL) Standard Deviation 7.06
Mean Serum Concentration Measured at Steady State 36/post-inf	109 Microgram/millilitre (μg/mL) Standard Deviation 24.4	88.9 Microgram/millilitre (μg/mL) Standard Deviation 13.9