Trial Outcomes & Findings for 38 Week Extension Study to CAIN457C2303 (NCT NCT01093846)
NCT ID: NCT01093846
Last Updated: 2016-02-22
Results Overview
The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
59 participants
Primary outcome timeframe
62 weeks
Results posted on
2016-02-22
Participant Flow
Participant milestones
| Measure |
AIN457 300 mg Every 2 Weeks
300 mg every two weeks
|
AIN457 300 mg Monthly
300 mg monthly
|
AIN457 Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
22
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
21
|
Reasons for withdrawal
| Measure |
AIN457 300 mg Every 2 Weeks
300 mg every two weeks
|
AIN457 300 mg Monthly
300 mg monthly
|
AIN457 Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
4
|
|
Overall Study
Condition no longer required study drug
|
1
|
1
|
1
|
|
Overall Study
Administrative Problems
|
18
|
17
|
15
|
Baseline Characteristics
38 Week Extension Study to CAIN457C2303
Baseline characteristics by cohort
| Measure |
AIN457 300 mg Every 2 Weeks
n=19 Participants
300 mg every two weeks
|
AIN457 300 mg Monthly
n=18 Participants
300 mg monthly
|
AIN457 Placebo
n=22 Participants
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 13.07 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 11.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 62 weeksThe primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .
Outcome measures
Outcome data not reported
Adverse Events
AIN457 300mg Every 2 Weeks
Serious events: 7 serious events
Other events: 28 other events
Deaths: 0 deaths
AIN457 300mg Monthly
Serious events: 8 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=39 participants at risk
AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
|
AIN457 300mg Monthly
n=39 participants at risk
AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
|
Placebo
n=39 participants at risk
Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Cataract cortical (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Cataract nuclear (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Cataract subcapsular (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Choroiditis (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Glaucoma (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Retinal infiltrates (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Retinal infiltrates (Study eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Uveitis (Fellow eye)
|
2.6%
1/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Uveitis (Study eye)
|
0.00%
0/39
|
2.6%
1/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
General disorders
Fatigue
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome (Fellow eye)
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome (Study eye)
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Infections and infestations
Folliculitis
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Infections and infestations
Hypopyon (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Investigations
Weight decreased
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
Other adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=39 participants at risk
AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
|
AIN457 300mg Monthly
n=39 participants at risk
AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
|
Placebo
n=39 participants at risk
Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
|
|---|---|---|---|
|
Eye disorders
Cataract subcapsular (Fellow eye)
|
10.3%
4/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Cataract subcapsular (Study eye)
|
10.3%
4/39
|
2.6%
1/39
|
2.6%
1/39
|
|
Eye disorders
Eye pain (Study eye)
|
2.6%
1/39
|
5.1%
2/39
|
5.1%
2/39
|
|
Eye disorders
Retinal vasculitis (Study eye)
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Vision blurred (Fellow eye)
|
0.00%
0/39
|
15.4%
6/39
|
2.6%
1/39
|
|
Eye disorders
Vision blurred (Study eye)
|
0.00%
0/39
|
5.1%
2/39
|
7.7%
3/39
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
10.3%
4/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Eye disorders
Vitreous floaters (Study eye)
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
3/39
|
7.7%
3/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.7%
3/39
|
5.1%
2/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39
|
7.7%
3/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39
|
7.7%
3/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39
|
0.00%
0/39
|
7.7%
3/39
|
|
General disorders
Fatigue
|
5.1%
2/39
|
5.1%
2/39
|
10.3%
4/39
|
|
General disorders
Non-cardiac chest pain
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
General disorders
Oedema peripheral
|
7.7%
3/39
|
5.1%
2/39
|
0.00%
0/39
|
|
General disorders
Pyrexia
|
15.4%
6/39
|
7.7%
3/39
|
10.3%
4/39
|
|
Infections and infestations
Conjunctivitis infective (Study eye)
|
2.6%
1/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Influenza
|
5.1%
2/39
|
10.3%
4/39
|
2.6%
1/39
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
2/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Oral herpes
|
0.00%
0/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Infections and infestations
Rash pustular
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Infections and infestations
Sinusitis
|
0.00%
0/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
3/39
|
12.8%
5/39
|
2.6%
1/39
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39
|
2.6%
1/39
|
5.1%
2/39
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Investigations
Blood glucose increased
|
0.00%
0/39
|
5.1%
2/39
|
0.00%
0/39
|
|
Investigations
Intraocular pressure increased (Study eye)
|
5.1%
2/39
|
7.7%
3/39
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
4/39
|
7.7%
3/39
|
7.7%
3/39
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
3/39
|
2.6%
1/39
|
5.1%
2/39
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39
|
7.7%
3/39
|
0.00%
0/39
|
|
Nervous system disorders
Headache
|
23.1%
9/39
|
17.9%
7/39
|
25.6%
10/39
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/39
|
7.7%
3/39
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/39
|
5.1%
2/39
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/39
|
2.6%
1/39
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/39
|
2.6%
1/39
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Vascular disorders
Hypertension
|
2.6%
1/39
|
5.1%
2/39
|
2.6%
1/39
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER