Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome (NCT NCT00465985)
NCT ID: NCT00465985
Last Updated: 2017-08-28
Results Overview
Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
32 weeks after study start
Results posted on
2017-08-28
Participant Flow
Participant milestones
| Measure |
ACZ885
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Part I - Open-label Treatment Period
STARTED
|
35
|
0
|
|
Part I - Open-label Treatment Period
COMPLETED
|
31
|
0
|
|
Part I - Open-label Treatment Period
NOT COMPLETED
|
4
|
0
|
|
Part II - 1:1 ACZ885:Placebo
STARTED
|
15
|
16
|
|
Part II - 1:1 ACZ885:Placebo
COMPLETED
|
15
|
4
|
|
Part II - 1:1 ACZ885:Placebo
NOT COMPLETED
|
0
|
12
|
|
Part III - Open-label Treatment Period
STARTED
|
31
|
0
|
|
Part III - Open-label Treatment Period
COMPLETED
|
29
|
0
|
|
Part III - Open-label Treatment Period
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
ACZ885
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Part I - Open-label Treatment Period
Unsatisfactory therapeutic effect
|
4
|
0
|
|
Part II - 1:1 ACZ885:Placebo
Unsatisfactory therapeutic effect
|
0
|
12
|
|
Part III - Open-label Treatment Period
Unsatisfactory therapeutic effect
|
1
|
0
|
|
Part III - Open-label Treatment Period
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Baseline characteristics by cohort
| Measure |
ACZ885
n=35 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 14.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 32 weeks after study startDetermined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.
Outcome measures
| Measure |
ACZ885
n=15 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
n=16 Participants
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)
|
0 percent of participants
|
81.3 percent of participants
|
PRIMARY outcome
Timeframe: 32 weeks after study startDisease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) \> 30 mg/L and either a PGA \> minimal, or PGA equal to minimal and \> minimal SD.
Outcome measures
| Measure |
ACZ885
n=15 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
n=16 Participants
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced a Disease Flare in Part II
|
0 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after study startTreatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by \>30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA \> 30 mg/L and either PGA \> minimal or PGA = minimal and SD \> minimal. Non-responders = no PR by Day 8 or no CR by Day 15.
Outcome measures
| Measure |
ACZ885
n=35 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Response in Part I (After 8 Weeks)
Complete response
|
31 Participants
25.200
|
—
|
|
Number of Participants With Treatment Response in Part I (After 8 Weeks)
Partial response
|
2 Participants
|
—
|
|
Number of Participants With Treatment Response in Part I (After 8 Weeks)
Disease flare
|
1 Participants
|
—
|
|
Number of Participants With Treatment Response in Part I (After 8 Weeks)
Non-responder (protocol violation)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 32 weeks after study startA 5-point scale was used for the Physician's global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items: * skin disease (urticarial skin rash) * arthralgia * myalgia * headache/migraine * conjunctivitis * fatigue/malaise * other symptoms related to autoinflammatory syndrome * other symptoms not related to autoinflammatory syndrome
Outcome measures
| Measure |
ACZ885
n=15 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
n=16 Participants
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Absent
|
8 Participants
|
0 Participants
|
|
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Minimal
|
7 Participants
|
4 Participants
|
|
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Mild
|
0 Participants
|
8 Participants
|
|
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Moderate
|
0 Participants
|
4 Participants
|
|
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8 and Week 32Population: Intention to treat (ITT)population and LOCF.
Outcome measures
| Measure |
ACZ885
n=15 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
n=16 Participants
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.
C reactive protein (CRP (mg/L))
|
1.10 mg/L
Standard Deviation 3.086
|
19.93 mg/L
Standard Deviation 24.175
|
|
Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.
Serum amyloid A (SAA (mg/L))
|
2.27 mg/L
Standard Deviation 8.604
|
71.09 mg/L
Standard Deviation 136.637
|
SECONDARY outcome
Timeframe: 48 weeks after study startPopulation: Patients in Part I and Part II who received at least one dose of ACZ885.
Assessed serum clearance of ACZ885.
Outcome measures
| Measure |
ACZ885
n=35 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Pharmacokinetics (CLD (L/d))
|
0.177 L/day
Standard Deviation 0.085
|
—
|
SECONDARY outcome
Timeframe: until Week 8Population: Intention to treat (ITT) population.
Outcome measures
| Measure |
ACZ885
n=35 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.
|
19.047 pg/mL
Standard Deviation 17.6609
|
—
|
SECONDARY outcome
Timeframe: 32 weeks after study startPopulation: Intention to treat (ITT) population.
Outcome measures
| Measure |
ACZ885
n=15 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
n=16 Participants
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.
|
21.943 pg/mL
Standard Deviation 10.3698
|
0.596 pg/mL
Standard Deviation 0.7289
|
SECONDARY outcome
Timeframe: 48 weeks after study startPopulation: Intention to treat (ITT) population.
Outcome measures
| Measure |
ACZ885
n=31 Participants
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Placebo
Placebo subcutaneous injection every 8 weeks.
|
|---|---|---|
|
Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.
|
23.018 pg/mL
Standard Deviation 16.5193
|
—
|
Adverse Events
Part I ACZ885
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Part II ACZ885
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part II Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part III ACZ885
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Entire Study ACZ885
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I ACZ885
n=35 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Part II ACZ885
n=15 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Part II Placebo
n=16 participants at risk
Placebo subcutaneous injection every 8 weeks.
|
Part III ACZ885
n=31 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Entire Study ACZ885
n=35 participants at risk
Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
Other adverse events
| Measure |
Part I ACZ885
n=35 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Part II ACZ885
n=15 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Part II Placebo
n=16 participants at risk
Placebo subcutaneous injection every 8 weeks.
|
Part III ACZ885
n=31 participants at risk
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
|
Entire Study ACZ885
n=35 participants at risk
Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
2/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
12.5%
2/16 • 48 weeks
|
16.1%
5/31 • 48 weeks
|
20.0%
7/35 • 48 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
14.3%
5/35 • 48 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Asthenia
|
5.7%
2/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
General disorders
Chest pain
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Fatigue
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Hangover
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Influenza like illness
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Immune system disorders
House dust allergy
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Bronchitis
|
8.6%
3/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
11.4%
4/35 • 48 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
11.4%
4/35 • 48 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
18.8%
3/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
17.1%
6/35 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
4/35 • 48 weeks
|
26.7%
4/15 • 48 weeks
|
12.5%
2/16 • 48 weeks
|
12.9%
4/31 • 48 weeks
|
34.3%
12/35 • 48 weeks
|
|
Infections and infestations
Oral herpes
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
12.5%
2/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
11.4%
4/35 • 48 weeks
|
|
Infections and infestations
Rhinitis
|
11.4%
4/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
12.5%
2/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
17.1%
6/35 • 48 weeks
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Investigations
Liver function test abnormal
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Investigations
Weight increased
|
8.6%
3/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
11.4%
4/35 • 48 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
11.4%
4/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
9.7%
3/31 • 48 weeks
|
14.3%
5/35 • 48 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Nervous system disorders
Sciatica
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Nervous system disorders
Tension headache
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Psychiatric disorders
Stress
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35 • 48 weeks
|
13.3%
2/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
6.5%
2/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
3.2%
1/31 • 48 weeks
|
8.6%
3/35 • 48 weeks
|
|
Vascular disorders
Haematoma
|
2.9%
1/35 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.2%
1/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Vascular disorders
Hot flush
|
2.9%
1/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
5.7%
2/35 • 48 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/35 • 48 weeks
|
6.7%
1/15 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/31 • 48 weeks
|
2.9%
1/35 • 48 weeks
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER