Trial Outcomes & Findings for Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis (NCT NCT00770965)
NCT ID: NCT00770965
Last Updated: 2018-03-12
Results Overview
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
COMPLETED
PHASE2
80 participants
baseline, week 4
2018-03-12
Participant Flow
A total of 80 participants were enrolled into the study. However, due to audit findings at one site, all 65 participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. The safety set included participants from all other sites.
Participant milestones
| Measure |
AIN457 0.3 mg/kg
Participants received AIN457 0.3 mg/kg IV on Day 1.
|
AIN457 1.0 mg/kg
Participants received AIN457 1.0 mg/kg IV on Day 1.
|
AIN457 3.0 mg/kg
Participants received AIN457 3.0 mg/kg IV on Day 1.
|
Placebo
Participants received placebo to AIN457A IV on day 1.
|
|---|---|---|---|---|
|
Safety Set
STARTED
|
2
|
4
|
4
|
5
|
|
Safety Set
COMPLETED
|
2
|
4
|
3
|
4
|
|
Safety Set
NOT COMPLETED
|
0
|
0
|
1
|
1
|
|
Excluded Set
STARTED
|
18
|
16
|
16
|
15
|
|
Excluded Set
COMPLETED
|
3
|
3
|
2
|
2
|
|
Excluded Set
NOT COMPLETED
|
15
|
13
|
14
|
13
|
Reasons for withdrawal
| Measure |
AIN457 0.3 mg/kg
Participants received AIN457 0.3 mg/kg IV on Day 1.
|
AIN457 1.0 mg/kg
Participants received AIN457 1.0 mg/kg IV on Day 1.
|
AIN457 3.0 mg/kg
Participants received AIN457 3.0 mg/kg IV on Day 1.
|
Placebo
Participants received placebo to AIN457A IV on day 1.
|
|---|---|---|---|---|
|
Safety Set
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Safety Set
Protocol deviation
|
0
|
0
|
1
|
0
|
|
Excluded Set
Administrative problems
|
14
|
12
|
12
|
10
|
|
Excluded Set
Withdrawal by Subject
|
1
|
1
|
2
|
3
|
Baseline Characteristics
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457 0.3 mg/kg
n=2 Participants
Participants received AIN457 0.3 mg/kg IV on Day 1.
|
AIN457 1.0 mg/kg
n=4 Participants
Participants received AIN457 1.0 mg/kg IV on Day 1.
|
AIN457 3.0 mg/kg
n=4 Participants
Participants received AIN457 3.0 mg/kg IV on Day 1.
|
Placebo
n=5 Participants
Participants received placebo to AIN457A IV on day 1.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 14.05 • n=4 Participants
|
52.5 Years
STANDARD_DEVIATION 10.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline, week 4This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, weeks 12, 14, 16, 20, 24, 28 and 32This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Outcome measures
Outcome data not reported
Adverse Events
AIN457 0.3 mg/kg
AIN457 1 mg/kg
AIN457 3 mg/kg
Placebo
Serious adverse events
| Measure |
AIN457 0.3 mg/kg
n=20 participants at risk
AIN457 0.3 mg/kg
|
AIN457 1 mg/kg
n=20 participants at risk
AIN457 1 mg/kg
|
AIN457 3 mg/kg
n=20 participants at risk
AIN457 3 mg/kg
|
Placebo
n=20 participants at risk
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
FEMORAL HERNIA, OBSTRUCTIVE
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
Other adverse events
| Measure |
AIN457 0.3 mg/kg
n=20 participants at risk
AIN457 0.3 mg/kg
|
AIN457 1 mg/kg
n=20 participants at risk
AIN457 1 mg/kg
|
AIN457 3 mg/kg
n=20 participants at risk
AIN457 3 mg/kg
|
Placebo
n=20 participants at risk
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
NAUSEA
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
NECROTISING COLITIS
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
VOMITING
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
General disorders
CYST
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
OEDEMA PERIPHERAL
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Infections and infestations
GENITAL HERPES
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/20
|
10.0%
2/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
5.0%
1/20
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
|
Vascular disorders
HYPERTENSION
|
10.0%
2/20
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
Additional Information
Study Director
Novartis
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER